Participate in a research study at PRC: Newcastle

CLOUDS study

Study date: 04 February 2022

Status: Open

CLOUDS Study - Cross-sectional investigation of burden of disease in newly operated stoma patients

The purpose of this study is to better understand the impact of living with a stoma on people who have had an ileostomy, or a colostomy.

• If you decide to take part, we will arrange a phone call to help you understand more about the study. We will explain in detail about what your participation involves, and you will be able to ask any questions you may have. You are welcome to bring a family member or a friend to this meeting. If you choose to participate in the investigation, we will then ask you to sign a consent form, in which you agree to participate in the study as described in this information sheet.

• During the study you will be invited for a virtual meeting with a member of the research team who will ask you a series of questions about your experience of living with a stoma and some personal information.

• Virtual calls: All meetings will be planned to be virtual using Microsoft Teams, Skype or Face Time, if technically possible. If a virtual visit is not possible, a face-to-face meeting will be scheduled, either at your home or at the hospital site.

• You will also be asked to fill in two (2) surveys. The surveys will be sent to you via a link in an email or SMS (text). The first survey will ask you questions on your personal experience of living with a stoma. The second survey is sent out at the end of the study so that you can feed back your experience of taking part in research. This is a way of demonstrating that your contribution is valued, and to help improve the way research studies are designed and delivered, now and in the future.

• We will ask you to keep information about the study confidential, meaning that you are welcome to discuss the trial with your loved ones and of course also your GP/stoma nurse if there should be a need for this, but we must ask you not to share information about the study in a larger forum, such as on social media.

To find out more contact us about the CLOUDS study

CORVIS (COPD) trial

Study date: 11 January 2022

Status: Open

The CORVIS trial is investigating the use of a new drug (inhaled via a handheld nebuliser to produce nitric oxide in the lungs) for treatment of infective exacerbations of COPD and bronchiectasis. Nitric oxide plays a key part in our body’s own defence against microbial infection in the lungs and has already been approved for use in the treatment of lung disease in neonates. In this study it will be used in addition to the usual treatment you would receive during an infective exacerbation, such as oral steroids and antibiotics.

CORVIS (COPD) Participant Information Sheet

Additional CORVIS information

PEARL

Study date: 03 November 2021

Status: Open

Pan-European prospective observational study of fremanezumab effectiveness in patients with chronic or episodic migraine in the Real-World: PEARL study

Fremanezumab is a humanized monoclonal antibody that selectively targets calcitonin gene-related peptide and is approved in Europe for migraine prevention in adults with ≥4 migraine days/month. The Pan-European Real Life (PEARL) study is a 24-month, prospective, observational study of fremanezumab in chronic or episodic migraine. End points include proportion of patients with ≥50% reduction in monthly migraine days during 6 months of treatment (primary); changes in monthly migraine days, disability scores and acute headache medication use; adherence and persistence; and effectiveness in patients switching from another calcitonin gene-related peptide pathway-targeting monoclonal antibody. PEARL is being conducted in approximately 100 centers in 11 European countries (estimated n = 1100). PEARL will generate important real-world data on effectiveness of fremanezumab and treatment patterns in patients with chronic migraine or episodic migraine. 

To find out more contact us about the PEARL study

NIMBLE

Study date: 31 August 2021

Status: Open

A 52-week, randomised, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinphilic phentoype treated with GSK3511294 compared with mepolizumab or benralizumab

To find out more contact us about the NIMBLE study

AERIFY-2

Study date: 29 July 2021

Status: Open

Randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD)

The purpose of the study is to investigate the effect, safety, and tolerability of the study drug for the treatment of patients with COPD, who continue to have symptoms on current treatment, and who are in need of an additional treatment to their current COPD management (standard of care SoC ). Simply put, we want to see if adding the drug on top of your current treatments improves COPD outcomes/exacerbations, therefore this study treatment will be given in addition to your current controller therapy.

The study is a multicentre study conducted worldwide. It will last approximately 72 weeks and will include 1170 participants, some ex-smokers, some ongoing smokers. Of those, about 740 participants will receive study drug itepekimab and about 430 participants will receive placebo (substance looks exactly like itepekimab but is not medically active). If you provide consent to participate, you will undergo study activities described in the following sections. During the study, the term “study treatment” will refer to either itepekimab or placebo.

This study is randomised, meaning study treatment will be assigned to you on a random basis (like flipping a coin). Your chance of receiving active treatment (itepekimab) if you are a former smoker at study start is 2 out of 3. Your chance of receiving active treatment (itepekimab) if you are a current smoker at study start is 1 out of 2. The study is also “blinded”, which means that both you and the study doctor will not know in which treatment group you are included and which study treatment you are receiving (itepekimab or placebo). However, in an emergency the exact treatment can be identified.

To find out more contact us about the AERIFY study

ALLEVIATE

Study date: 24 June 2021

Status: Open

Interventional, randomised, double-blind, parallel-group, placebo-controlled delayed-start study to evaluate the efficacy and safety of eptinezumab in patients with episodic Cluster Headache (eCXH)

To find out more contact us about the ALLEVIATE study

Study of Erenumab in Adults with Chronic Migraine and Medication Overuse Headache

Study date: 23 June 2021

Status: Open

20170703 is a study in adult participants with Chronic Migraine (CM) and Medication Overuse Headache (MOH). The purpose of conducting the study is to better understand the effectiveness and safety of erenumab compared to placebo when given to a targeted population diagnosed with CM and MOH that have at least one preventative treatment failure, to see if it makes any changes in the number of days participants suffer from monthly headache days (MHD) and are able to revert the medication overuse status.

Erenumab study details

Erenumab study on the Be Part of Research website

 

There are currently no upcoming studies.