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MANDALA study: Adult Participant Information Sheet and Informed Consent Form

 

Contents

This study took place at PRC: Newcastle, part of The Newcastle upon Tyne Hospitals NHS Foundation Trust. It is now closed and is no longer accepting new participants.

Study details

Study Title:

A Long-term, Randomized, Double-Blind, Multicenter, Parallel group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older with Asthma (MANDALA)

Short Title:

MANDALA study

Protocol Number:

AV003

Sponsor:

Bond Avillion 2 Development LP

IRAS Number:

256161

Study Doctor:

Dr Andrew Stanton

Institution: 

NIHR Patient Recruitment Centre: Newcastle

Newcastle upon Tyne Hospitals NHS Foundation Trust

0191 282 3655

07510 587 109

Introduction

You are being asked to take part in this study because you have been diagnosed withmoderate to severe asthma. Your participation is entirely voluntary. If you do not want to take part in the study, your decision will be respected. If you decide not to take part in this study, you can continue with your current medical care without consequence. This study involves research. Before you give your consent to take part in this study, it is important that you read the following information and ask as many questions as necessary to be sure you understand what you will be asked to do and what the risks and possible benefits are for you. Take all the time you need to carefully read the following information, or discuss it with relatives and/or friends, before signing the informed consent form below. You may also wish to discuss your possible participation in the study with your GP. This Participant Information Sheet and Consent Form may contain words that you do not understand. Please ask the study doctor or the study staff to explain any words or information that is not clear to you.

Why is this study being done?

Bond Avillion 2 Development LP (Avillion), the sponsor of this study, has begun a study of an investigational drug called PT027 (also known as the “study drug”), which is acombination of budesonide and salbutamol/albuterol sulfate (BDA) given in a metered-dose inhaler (MDI) as a possible treatment for asthma symptoms. An MDI is a device that delivers a measured amount of medication as a mist that the patient can inhale. This study-drug combination delivers 2 well-established asthma treatments. Budesonide is a well-established corticosteroid treatment that helps to reduce swelling and tightening of airways. Many patients take budesonide regularly as a “controller” medication to control chronic symptoms and prevent asthma attacks. Albuterol is known in many countries as salbutamol. Salbutamol/Albuterol is a treatment that is widely used as needed for short-term treatment of asthma symptoms, or a “reliever” medication. It is hoped that this investigational drug combination of both budesonide and salbutamol/albuterol will be better at preventing severe asthma attacks compared to some standard “reliever” medications.

An investigational drug is one that has not been approved by any country’s regulatory authorities (government officials who monitor the safety of medication to ensure your health).

In this study, you will continue to take your regular “controller” medications. You will be given a new “reliever” inhaler to use when you have asthma symptoms. The new inhaler will contain either a combination of budesonide and albuterol sulfate or salbutamol/albuterol. You or your study doctor will not know which treatment is in your inhaler. The main purpose of this study is to learn how well the study drug works compared to salbutamol/albuterol alone in reducing your risk of having another severe asthma attack. The study will also investigate how safe the study drug is compared to salbutamol/albuterol alone given in an MDI for asthma attacks.

How many people will take part in this study?

This study will take place in approximately 380 medical centres in more than 10 countries with about 3100 people aged 4 years and above with asthma.

Who has reviewed this study?

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by the East Midlands-Nottingham 2 Research Ethics Committee.

How long will my participation in this study last?

You will visit the study site 8 times although the treatment period will be a minimum of 24 weeks, with possible additional visits every 3 months until the study is completed. The length of your participation in this study will depend on the study completion date, which will occur after all participants have completed the treatment period of 24 weeks on study and after a specific number (570) of asthma attacks has happened in the whole global study group. All participants have to have at least 24 weeks of treatment, but some participants may be in the study longer than 2 years. Your study doctor will let you know when the end of study is due to happen and will let you know when to return for your final visit.

What will happen during this study?

The study is divided into 3 time periods: a screening period, a treatment period, and a safety follow-up period. During the screening period and the treatment period you will have at least 8 visits with your study doctor at the study centre; this period may be extended. During the safety follow-up period, the study doctor or site staff will call you by telephone 2 - 4 weeks after the End of Study Visit, or if you discontinue from the study earlier.

Before any study-related tests and procedures can be done, you will be asked to read this Participant Information Sheet and sign the Informed Consent Form. After you sign the Informed Consent Form, you may be asked for permission to check your medical records prior to the screening visit to confirm some eligibility requirements. The study will begin with a Screening Visit. The purpose of the Screening Visit is to confirm if you meet all requirements to take part in this study. If you do not meet the requirements, the study doctor will explain why and will discuss other treatment options with you. During the screening phase, you will be required to bring all of your current “reliever” inhalers to the study site and to use only the “reliever” inhalers provided by your study doctor.

If the study doctor confirms that you meet all of the requirements to be in the study, you will
be randomly assigned (like picking straws) to 1 of the following 3 treatment groups:

1. budesonide/albuterol 80/180 µg (given as 2 actuations of 40/90 µg per puff) as needed
2. budesonide/albuterol 160/180 µg (given as 2 actuations of 80/90 µg per puff) as
needed
3. albuterol sulfate 180 µg (given as 2 actuations of 90 µg per puff) as needed

The maximum daily dosage of study medication should not exceed 12 puffs per day. The recommended maximum dose is 8 puffs per day and you are advised to contact your study doctor if you need to take more than 8 puffs per day.

You will have a 1 in 3 chance of receiving each of the treatments.

You will not be told which treatment that you are receiving. The study doctor and any other people involved in the study will not know which treatment you are receiving. However, your study doctor can find out this information if it becomes necessary for your safety.

Study Procedures and Assessments

A description of the procedures and assessments that will be performed during the study, including the screening visit, is shown below.

In addition to the visits described, the study doctor may ask you to come in for extra visits, if necessary, for your safety. If you have any questions about the procedures, you should discuss them with the study doctor.

Screening

 Visit 1, Week-4 to- 2, Day- 28 to- 14, Day 0

  • Informed consent; review study requirements, medical/personal history, receive eDiary and instructions; albuterol/salbutamol reversibility test; receive albuterol for as needed - use only during screening
  • Physical examination
  • Height (cm)
  • ECG
  • Pregnancy test (if applicable)
  • Blood pressure/pulse
  • Spirometry test
  • Blood samples for safety lab tests and morning cortisol assessment
  • Multiple questionnaires
  • Discuss how you are feeling and other medications you are taking
  • Review exacerbation events; review of peak expiratory flow (PEF), use of study drug, asthma daytime/ night-time symptoms,and night- time awakenings due to asthma

Treatment Period

Visit 2, Week 0, Day 1

  • ECG
  • Pregnancy test (if applicable)
  • Blood pressure/pulse
  • Spirometry test
  • Multiple questionnaires
  • Discuss how you are feeling and other medications you are taking
  • Review e-Diary
  • Review exacerbation events; review of peak expiratory flow (PEF), use of study drug, asthma daytime/ night-time symptoms,and night- time awakenings due to asthma
  • Receive study drug and/or give back any study drug not takem

Visit 3, Week 4, Day 28

  • Pregnancy test (if applicable)
  • Blood pressure/pulse
  • Multiple questionnaires
  • Discuss how you are feeling and other medications you are taking
  • Review e-Diary
  • Review exacerbation events; review of peak expiratory flow (PEF), use of study drug, asthma daytime/ night-time symptoms,and night- time awakenings due to asthma
  • Receive study drug and/or give back any study drug not taken

Visit 4, Week 8, Day 56

  • Pregnancy test (if applicable)
  • Blood pressure/pulse
  • Multiple questionnaires
  • Discuss how you are feeling and other medications you are taking
  • Review e-Diary
  • Review exacerbation events; review of peak expiratory flow (PEF), use of study drug, asthma daytime/ night-time symptoms,and night- time awakenings due to asthma
  • Receive study drug and/or give back any study drug not taken

Visit 5, Week 12, Day 84

  • Pregnancy test (if applicable)
  • Blood pressure/pulse
  • Multiple questionnaires
  • Discuss how you are feeling and other medications you are taking
  • Review e-Diary
  • Review exacerbation events; review of peak expiratory flow (PEF), use of study drug, asthma daytime/ night-time symptoms,and night- time awakenings due to asthma
  • Receive study drug and/or give back any study drug not taken

Visit 6, Week 24, Day 168

  • Height (cm)
  • ECG
  • Pregnancy test (if applicable)
  • Blood pressure/pulse
  • Spirometry
  • Multiple questionnaires
  • Discuss how you are feeling and other medications you are taking
  • Review e-Diary
  • Review exacerbation events; review of peak expiratory flow (PEF), use of study drug, asthma daytime/ night-time symptoms,and night- time awakenings due to asthma
  • Receive study drug and/or give back any study drug not taken

Visit 7, Week 36, Day 252

  • Pregnancy test (if applicable)
  • Blood pressure/pulse
  • Multiple questionnaires
  • Discuss how you are feeling and other medications you are taking
  • Review e-Diary
  • Review exacerbation events; review of peak expiratory flow (PEF), use of study drug, asthma daytime/ night-time symptoms,and night- time awakenings due to asthma
  • Receive study drug and/or give back any study drug not taken

Extension phase - every 12 weeks until completion date

  • Pregnancy test (if applicable)
  • Blood pressure/pulse
  • Multiple questionnaires
  • Discuss how you are feeling and other medications you are taking
  • Review e-Diary
  • Review exacerbation events; review of peak expiratory flow (PEF), use of study drug, asthma daytime/ night-time symptoms,and night- time awakenings due to asthma
  • Receive study drug and/or give back any study drug not taken

End of study visit

  • Physical examination
  • Height (cm)
  • ECG
  • Pregnancy test (if applicable)
  • Blood pressure/pulse
  • Spirometry test
  • Blood samples for safety lab tests and morning cortisol assessment
  • Multiple questionnaires
  • Discuss how you are feeling and other medications you are taking
  • Review exacerbation events; review of peak expiratory flow (PEF), use of study drug, asthma daytime/ night-time symptoms,and night- time awakenings due to asthma
  • Receive study drug and/or give back any study drug not taken

PDV (if necessary)

  • Physical examination
  • Height (cm)
  • ECG
  • Pregnancy test (if applicable)
  • Blood pressure/pulse
  • Spirometry test
  • Blood samples for safety lab tests and morning cortisol assessment
  • Multiple questionnaires
  • Discuss how you are feeling and other medications you are taking
  • Review exacerbation events; review of peak expiratory flow (PEF), use of study drug, asthma daytime/ night-time symptoms,and night- time awakenings due to asthma
  • Receive study drug and/or give back any study drug not taken

Follow-up

Follow-up Phone Call

  • Discuss how you are feeling and other medications you are taking

Abbreviations: ECG=electrocardiogram; eDiary=electronic diary; PDV=Premature Discontinuation Visit.

a The follow-up phone call will occur 2 to 4 weeks after the last study dose.

b A serum pregnancy test will be performed at Visit 1, 6 and EOS/PDV; urine pregnancy test will be performed at all other clinic visits (for women of childbearing potential only).

c Additional height (cm) assessments to be collected for participants = 18 years of age at time of consent ONLY.

 

Multiple questionnaires: these will be completed to assess overall health and well-being as well as asthma symptoms and how they affect your daily life.

Spirometry test: is carried out using a machine called a spirometer that shows how well your lungs work by measuring the amount of air you exhale after forced effort in the first second.

Albuterol/salbutamol reversibility test: is also carried out using a spirometer. It measures how well your lungs work before and after you have taken medication and is sometimes done to investigate a diagnosis of asthma, or when diagnosis is not clear.

Electrocardiogram (ECG): painless, non-invasive procedure that measures the electrical activity of your heart with electrodes (patches) placed on your chest.

Physical Examination: overall check by the study doctor to see how you are feeling, checking different body parts, such as your heart, lungs, stomach, etc.

Vital Signs: checks your pulse and blood pressure.

Pregnancy Testing: will be done for females of childbearing potential to check if you may be pregnant. At visits 1, 6, End of Study/Premature Discontinuation visits, a blood sample will be taken for pregnancy testing. At all other visits, a urine sample will be taken for pregnancy testing. There is additional information relating to pregnancy noted further in this Information Sheet.

Medical History: you will be asked about your overall health and previous health conditions, surgeries and hospitalisations you have had as well as medications you have been taking and are currently taking.

eDiary: You will be given a device (electronic diary or eDiary) in which you will record symptoms and whether you had to take medications for these symptoms. You will be shown how it works and how to record information in this device. You will record your asthma symptoms in the eDiary and review these at study visits. The eDiary will also be set with limits for your asthma symptoms. You and the study centre will receive alerts if there are changes in your symptoms or if your asthma is reaching a limit set in the device that your symptoms should not reach. This alert will trigger a call between you and the study centre so you can discuss your symptoms and be advised for your safety.

Safety laboratory tests: blood samples are tested to measure various items in your blood to ensure that the study treatments are safe. A total of approximately 40 mL or 4 tablespoons of blood will be collected during the study.

Morning serum cortisol test: A cortisol test is performed with part of your blood sample. It measures the level of the hormone cortisol in the blood. Your cortisol level will be checked to see if the study drug could have any effect on your adrenal or pituitary glands. In children and adolescents it may indicate a drug effect on height.

Peak expiratory flow (PEF): PEF is a measurement of maximum speed of your breath as you exhale. It is measured with a peak flow meter (AM3, a part of your eDiary). The assessment measures airflow through your lungs and evaluates the degree of obstruction of your airways. When patients are well, measurements are higher, while lower measurements mean airways are constricted. With this assessment, the study doctor can determine how well your lungs are working, the severity of your asthma symptoms and make treatment decisions.

What do I have to do?

  • During the study, you will have the following responsibilities:
  • Tell your study doctor if you have any allergies, including drug allergies. If you are unsure, ask your GP.
  • Attend all scheduled visits.
  • Take the study drug as directed. The maximum daily dose of study drug should not total more than 12 puffs per day, although it is recommended that you should contact the study site or investigator if your asthma symptoms require you to take more than 8 puffs a day.
  • Return any unused study drug and containers as instructed by the study staff.
  • Follow the study doctor’s instructions about whether you may continue to take your regular prescribed medications or over-the-counter medicines during the study period.
  • Tell the study doctor of any changes to your current medications, illnesses or injuries, unexpected or troublesome side effects, or problems that occur during the study.
  • Do not take any other asthma medication without telling the study doctor.
  • Complete the eDiary and assessments on AM3 device as instructed.
  • Notify the study doctor if you have an asthma attack.
  • Clean the device (MDI) as instructed to ensure proper working of the inhaler.
  • Tell the study doctor if you plan to have an elective surgery or any other medical treatment or procedure.
  • You should continue to make regular visits to your GP or any other special doctors whom you were seeing before starting the study, since being in the study does not replace regular medical care.
  • Make sure that the study drug is kept out of the reach of children and people who have a limited capacity to read or understand. You are the only person who should take the study drug.
  • Contact the study doctor if you find you have any questions about the study after you sign this form.
  • You and/or your partner must use a reliable form of contraception during the study. If you or your partner becomes pregnant while you are in the study, be sure to tell the study doctor as soon as possible.

What are the benefits of being in this study?

There is no guarantee that you will receive any benefit from participating in this study. It ishoped that if you receive the combination of budesonide and albuterol sulfate (BDA MDI), you may have a potential reduction in the risk of asthma exacerbation and improvement in the control of asthma symptoms and lung function beyond what is typically seen with albuterol alone, however this cannot be guaranteed. However, you will be helping others by contributing to medical research.

What are the risks and possible discomforts?

Study treatment

Any study has risks, which may include things that could make you sick, make you feel uncomfortable, or harm you. You might experience side effects related to the study drug while participating in the study. All participants in the study will be watched carefully for any side effects; however, the study team does not know all the side effects that the study drug
may have on you. The study team may give you medicines to help reduce side effects. These side effects may be mild or serious. In some cases, these side effects might be long lasting or permanent and may even be life threatening.

Taking part in this study involves some risks and possible discomfort to you, for example, the
study drug may not work for you.

Side effects

  • The study drug may cause unpleasant side effects or reactions. The most commonly
    reported side effects in other studies of budesonide and salbutamol/albuterol were:


Very common (frequency observed =1 in 10)

  • Respiratory infection
  • Nervousness

Common (frequency observed = 1 in 10 and = 1in 10)

  • Cardiovascular (heart) effects
  • irritation in the throat
  • fungal infection in the mouth, throat, and oesophagus
  • hoarseness
  • coughing
  • behavioral disturbances
  • rash
  • skin inflammation
  • urticarial (hives)
  • angioedema (swelling under the skin)
  • restlessness
  • depression
  • not enough potassium in the blood

Uncommon (frequency observed between 1 in 1000 and 1 in 100)

  • restlessness
  • depression
  • skin bruising

Rare but serious (frequency observed – less than 1 in 1000)

  • anaphylactic reaction (serious, potentially life-threatening allergic reaction to a substance)
  • breathing distress caused by narrowing of the airways
  • paradoxical bronchospasm (constriction of airways)

Contact the study centre if you have any side effectsrelated to the study drug or any medications you are taking.

Since the study drug is investigational, there may be risks and side effects that are unknown. All drugs have a possible risk of an allergic reaction. Some signs of allergic reaction are: rash or hives, difficulty breathing, wheezing, dizziness or lightheadedness, swelling near the mouth, nose, or eyes; fast heartbeat or sweating. You should get medical help right away and contact the study doctor or staff if you have any of these or any other side effects during the study.

Study visits/procedures

  • Blood samples: Taking blood from your arm may cause faintness and/or swelling, pain, redness, bruising, bleeding at the collection site, or infection (infection rarely happens) at the site where the needle is inserted.
  • Electrocardiogram (ECG): Skin irritation is rare but could occur during an ECG from the electrode patches or gel that is used. Male participants may need to have their chest shaved to perform the ECG.
  • Spirometry & Reversibility Testing: You may feel short of breath or dizzy for a moment after you perform the test.

If you have private insurance such as life assurance, travel insurance, private medical insurance, you should check with the insurance company before agreeing to take part in this study to ensure your participation will not affect any cover you have. 

COVID-19

Attending study visits in areas where there are cases of coronavirus (COVID-19) may increase your risk of exposure to the virus. If COVID-19 cases increase locally and lockdown guidance is implemented, you may be asked to attend your study visit earlier or later than planned, or to perform your visit from home (“remotely”) for a temporary period. If you experience signs or symptoms of COVID-19, you should contact your study doctor and arrange for your visit to be delayed or to be performed remotely, until after the recommended quarantine period.

If your study visits need to be performed remotely, your study doctor will explain how this will work and ask you to confirm your consent for a remote visit.

  • Your study doctor or designee will complete some of the study questionnaires for you
    with the responses you provide verbally.
  • Some safety assessments will be delayed (for example, measurement of blood pressure and heart rate) or missed until you are next able to attend the clinic for visits and assessments.
  • For women, a negative pregnancy test will be required before you are given more study drug.

Your study doctor will remain responsible for your on-going safety and will inform you if there are any changes to the benefit-risk assessment of being on the study treatment or your participation in the study.

You remain free to withdraw from the study at any time and for any reason.

Pregnancy/Birth Control

Women

Taking the study drug may involve unknown risks to a pregnant woman, an embryo, foetus (unborn baby), or nursing infant. Therefore, if you are pregnant, planning to become pregnant, or are breastfeeding a child, you cannot take part in this study.

Before entering the study, a pregnancy test will be done for all women who are able to become pregnant. This test might not detect an early pregnancy. Pregnancy tests will be repeated at every visit during the study.

The only certain way not to become pregnant is to not have sex. If you choose to be sexually active during the study and are of childbearing potential, you must use an effective method of birth control as described below while you are taking part in this study and for 2 weeks after you finish the study treatment. You are considered to be of non-childbearing potential if you are physiologically incapable of becoming pregnant, including being 2 years postmenopausal, or surgically sterile. Menopausal women are defined as women who have not had a period for 12 consecutive months or more after stopping hormonal treatment.

If you are already using a method of birth control, the study doctor or study staff will discuss with you whether your current method of birth control is acceptable for use during this study. Methods of effective birth control acceptable for this study include total abstinence (if this is consistent with your current lifestyle), oral contraceptive, contraceptive implant, injectable
hormonal contraceptive, male condom with either cap, diaphragm, or sponge with spermicide, and/or male partner who has been surgically sterilised by vasectomy. Tubal ligation (sterilisation) is considered an acceptable permanent birth control method.

If during the study or in the follow-up phase you become pregnant, you should tell the study doctor as soon as possible. The study drug will be stopped, and your involvement in this study will end. Avillion will ask if they can collect information from you regarding the pregnancy as well as the outcome of pregnancy.

Men

If you choose to be sexually active during the study, you must use an effective method of birth control while you are taking part in this study and for 2 weeks after you finish the study treatment. Male participants should either be surgically sterile by vasectomy or agree to use a double-barrier method of contraception i.e. a combination of male condom with spermicide, cervical cap, diaphragm, or sponge.

You should not donate sperm during your participation in the study and for 2 weeks after you finish study treatment. If your partner becomes pregnant while you are participating in the study, the Sponsor would like to receive updates on the progress of the pregnancy and its outcome. If your partner agrees to this, she will be asked to sign a separate informed consent form.

What if there are new findings?

If new findings that would affect your safety and willingness to participate in the study are identified while you are in the study, you will be told as soon as possible, so you can decide whether to leave the study or continue. If you decide to continue in the study, you may be asked to sign an updated Informed Consent Form.

What other options are available if I do not take part in this study?

You do not have to take part in the study to treat your asthma. There are other options of therapies. There are many approved therapies available for the treatment of asthma. Different medications work in different ways in your body. Below is a list of the names of the types of medicines used to treat asthma. The study doctor can provide you with more details. The study staff can discuss the risks and benefits of these approved therapies with you. If you decide not to participate in this study, then your alternative treatments may include, but are
not limited to:

  • Long-acting beta agonists (LABAs)
  • Long-acting muscarinic antagonists (LAMAs)
  • Short-acting beta agonists (SABAs)
  • Leukotriene receptor antagonists (LTRAs)
  • Inhaled corticosteroids (ICs)
  • Methylxanthines

Your GP or the study doctor can answer any questions that you have about other treatments.

Who is paying for this study?

This study is being funded by Avillion, the Sponsor of this study. Avillion will pay Newcastle upon Tyne Hospitals NHS Foundation Trust for including you in this study.

Will I be paid for being in the study?

You may receive a payment of up to £44 per study visit, in order to compensate you for time and inconvenience, or loss of earnings due to your participation in this study. You will also be reimbursed for reasonable travelling expenses.

What if I get sick or hurt?

If you require medical treatment for an illness or injury that is a direct result of taking the study drug, Avillion will pay for reasonable and routine costs of such treatments if the following conditions are met:

  • You report the illness or injury right away.
  • The illness or injury was a result of taking part in the study.
  • You followed the study doctor's instructions.
  • The illness or injury is not part of your medical history.
  • The cost of treatment or any part of the costs is not covered by any other health insurance, or other institutions providing coverage for health care.

Avillion has insurance for these circumstances in accordance with applicable law.

In the event that something does go wrong and you are harmed during the research and this is due to someone's negligence then you may have grounds for a legal action for compensation against Avillion, or Newcastle upon Tyne Hospitals NHS Foundation Trust, but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you (if appropriate).

If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions 0191 282 3655.

Can I leave the study after it has begun?

Yes. Taking part in this study is voluntary, and you can leave the study at any time for any reason, without having to state the reason. There will also not be any penalty or loss of benefits to which you are entitled at this site if you decide not to take part or if you decide to leave the study.

If you decide to leave the study, you should contact the study doctor who will explain the safest way to end participation, which may involve the completion of some final tests and examinations. You should also contact your GP so he or she can provide you with the best course of continuing care.

If you discontinue study drug prior to End of Study visit you will be asked to remain in the study to complete all remaining study visits during the treatment period. If you do not wish to continue participation at all study visits, the investigator or study staff will ask if you would agree to collection of limited information after treatment discontinuation such as whether you have experienced severe asthma exacerbations, side effects from any medication you may be taking, any illnesses or injuries, and current medications including asthma treatment every three months via phone until the end of the study. You will be asked to sign a separate page to confirm your decision to either continue in the study with study visits or only limited phone calls. After study drug discontinuation you will return to an asthma treatment as advised by your GP.

If you choose not to continue with study assessments, you will complete the Premature Discontinuation Visit. A follow-up telephone call will be performed at least 14 days after the last study drug dose. In the event the Premature Discontinuation Visit is performed >14 days post last study drug intake, a follow-up call will not be performed.

The study doctor or Avillion can remove you from the study, without your permission, for any reason. Possible reasons for doing so include the following:

  • adverse event
  • if you have more than 3 severe exacerbations within a 3-month period
  • if you have 5 or more total severe exacerbation events
  • if you have a single severe exacerbation event longer than 20 days in duration
  • female participant becomes pregnant
  • any change in your medical condition that might make continuation in the study harmful to you
  • your failure to follow the study doctor’s instructions
  • discovery that you do not meet the study requirements
  • cancellation of the study by the Sponsor or health authority
  • administrative reasons

What will happen to the samples that I provide?

The blood samples that you give will be used only for specific tests that are needed for this study. Your samples will be destroyed as soon as possible after those specific tests are completed. Your samples will be tested and destroyed according to the standard procedures of the laboratory: Eurofins Central Laboratory BV, Bergschot 71, Breda, 4817, Netherlands. If you withdraw from the study, your samples will still be analysed, unless you state otherwise.

What happens when this study stops?

When the study stops, the study drug will no longer be available to you. You have the right to be informed of the overall results of the study. If you have any further questions about what happens at the end of the study or how to access the study results, please contact your study doctor.

Will my records be kept private?

Bond Avillion 2 Development LP is the sponsor for this study based in Guernsey, Channel Islands. We will be using information from you and/or your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. Bond Avillion 2 Development LP will keep identifiable information about you for the purpose of this study for 25 years after the study has finished. This information will be held by the sponsor organisation and/or Newcastle upon Tyne Hospitals NHS Foundation Trust.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible. You can find out more about how we use your information by contacting:

The Sponsor: Bond Avillion 2 Development LP, Nerine House, St George’s Place, St Peter Port, GY1 3ZG, Guernsey

The Representative: Avillion LLP, Central Working, Eccleston Yards, 25 Eccleston Place, London, SW1W 9NF, United Kingdom

You can contact the Sponsor’s data protection officer at:

Nicole Rensonnet, the Data Protection Officer of the Sponsor, by phone at +44 56 0375 0073, by email at PT027@mydata-trust.info or in writing to MyData-TRUST, Rue Descartes, 7, B1, BE 7000, Mons.

Newcastle upon Tyne Hospitals NHS Foundation Trust will collect information from you and/or your medical records for this research study in accordance with our instructions.

Newcastle upon Tyne Hospitals NHS Foundation Trust will use your name, NHS number and contact details, date/year of birth, gender, height, weight, racial or ethnic origin, health information, x-ray images to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from Bond Avillion 2 Development LP and regulatory organisations may look at your medical and research records to check the accuracy of the research study. Newcastle upon Tyne Hospitals NHS Foundation Trust will pass these details to Bond Avillion 2 Development LP along with the information collected from you and/or your medical records. The only people in Bond Avillion 2 Development LP who will have access to information that identifies you will be people who need to contact you to follow-up or audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details.

Newcastle upon Tyne Hospitals NHS Foundation Trust will keep identifiable information about you from this study for a period of 2 years after the last approval of a marketing application or at least 2 years have elapsed since the formal discontinuation of clinical
development of the investigational product.

Bond Avillion 2 Development LP will collect information about you for this research study from Dr Stanton or your usual doctor. Dr Stanton will not provide any identifying information about you to Bond Avillion 2 Development LP. We will use this information to study your response to the study drug.

When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research.

This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.

If you have any questions, concerns, or complaints as to how your information is used, you are advised to contact the study team or the Data Protection Officer of Newcastle upon Tyne Hospitals on 0191 213 7368 in the first instance.

If you wish to raise a complaint on how we have handled your personal data or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).

With your permission, your GP will be told you are taking part in this study. If you report any side effects or any serious medical events to your GP, they may need to share this medical information with the study doctor to ensure you receive the appropriate treatment.

If you need to have a remote study visit performed due to temporary COVID-19 lockdown measures and require re-supply of study drug, with your verbal consent, the study doctor will share your contact information with a courier company in order to deliver study drug to you at your home.

What if I have a question or concern?

You should feel free to ask questions about the study and your rights as a participant before, during, and after the study. If you have any concerns or complaints at any time about this study or feel you have been hurt by being part of this study and it is not an emergency, you should call:

Dr Andrew Stanton – Principal Investigator

Gez Richell – Senior Research Nurse

0191 282 3655You may also contact North of Tyne PALS on northoftynepals@nhct.nhs.uk or 0800 032 0202

A description of this clinical trial will be available on http://www.ClinicalTrials.gov. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.