Respiratory Research Newsletter
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1 Date Published: September 2012 Respiratory Research Newsletter Contents Research at the Belfast Trust 1 NICRN Respiratory Health 2 The Respiratory Research Team 3 Our Partners 4 Getting Involved in Upcoming 5 Studies Current Research Closed to 6-7 Recruitment Research Collaborators 8-9 News & Events 10
2 Research at the Belfast Trust Within the Belfast Trust, research is recognised as an important role to help improve patient care. Clinical research studies look at whether different treatments work and if they are safe to use to treat diseases. Before any research study is set up in the Belfast Trust, it is examined to make sure it is safe for patients. At the Regional Respiratory Centre, the research team work closely with the clinical teams. This is to make sure that all patients get the best clinical care whilst having an opportunity to take part in research studies. To become involved in research within the Belfast Trust a patient will be invited by researchers to take part. Taking part in a study is voluntary and if a patient does not wish to take part, normal care is not affected in any way. Why get involved in a research study? There are many different reasons for getting involved in a research study: Some people want to become more active in their health care and feel good about helping advance medical knowledge. Some people feel that they benefit as they get regular follow up meetings when involved in a clinical study. This can mean that health problems may be found earlier. Research studies also offer high quality care and patients may be among the first to benefit if a new treatment is proven to work. Becoming involved in a clinical trial gives patients an active role in a decision that affects their treatment and their life. Patients also have the chance to help others and improve treatment. We have a wide range of studies looking at new therapies in a variety of respiratory illnesses including cystic fibrosis (CF), asthma, bronchiectasis and chronic obstructive pulmonary disease (COPD). Dr Stephen Rowan demonstrating one of our lung function tests. 1
3 Northern Ireland Clinical Research Network (NICRN) Respiratory Health The Northern Ireland Clinical Research Network (NICRN) is made up of ten regional interest groups, all lead by specialist clinicians in research. The NICRN Respiratory Health interest group undertakes research in respiratory medicine throughout Northern Ireland. It is a branch of a UK-wide project to involve patients and clinicians in high-quality research studies. The NICRN is funded by the Health and Social Care (HSC) Research and Development division. It supports high quality research studies across all HSC Trusts in Northern Ireland. The NICRN s Respiratory Health interest group aims to: Promote research in respiratory medicine within Northern Ireland; Attract clinical trials in respiratory medicine to Northern Ireland; Conduct clinical trials across Northern Ireland to the highest standards of quality and safety; Provide resources and staff to help the start-up of new trials in respiratory medicine; Improve access for respiratory patients to new cutting-edge treatments. Areas of interest to the NICRN Respiratory Health Exploring and providing new/novel therapies through partnership with the commercial sector. Evaluation of therapies for cystic fibrosis (CF), asthma, bronchiectasis and chronic obstructive pulmonary disease (COPD). Studies examining the pathology behind cystic fibrosis, in support with international partners. Cystic fibrosis trials in children and adults. For more information on the work of NICRN (Respiratory Health) please contact the NICRN Co-ordinating Centre: Telephone: Angelina.O Neill@belfasttrust.hscni.net Visit our website: 2
4 The Respiratory Research Team The Respiratory Health interest group comprises a dedicated, professional team. Clinical Leads Dr Judy Bradley 1,2 Dr Lorcan McGarvey 1,3 The Clinical Lead Provides leadership and strategic direction of respiratory portfolio. Gives direction and leads the clinical management group. Works at a national level within networks to share information and good practice with other professional groups. Principal Investigators (PI s) Dr Judy Bradley 1,2 Dr Rory Convery 3 Dr Damian Downey 1 Prof Stuart Elborn 1,4 Prof Liam Heaney 1,4 Dr Martin Kelly 5 Dr Nick Magee 1 Dr Lorcan McGarvey 1,4 Dr Brenda O Neill 2 The Principal Investigator Has overall responsibility for the study and ensures the study meets safety guidelines. Leads the study team: physiotherapists, nurses, clinical physiologists and medics. Meets with patients who are interested in taking part in a study to: o discuss the trial and answer questions, o look at their medical history, and o decide if they are suitable to take part. Looks at laboratory results from the study visits. Makes sure that all patients receive professional and safe clinical care. Coordinators Dr Mary Armstrong 1 Research physiotherapist Dr Denise Cosgrove 1,2 Research physiotherapist Dr Lisa Kent 1,2 Research physiotherapist Dr Susan Martin 1 Research clinical physiologist Vivienne McClenaghan 1 Research nurse Adrian McDonald 5 Research nurse Roisin Stone 1 Research nurse The Coordinator Is responsible for the day-to-day running of a study. Helps identify suitable patients for studies. Organises and conducts study visits. Works closely with the PI and the clinical team to make sure patients receive professional and safe medical care. Works closely with patients to teach the study tasks, for example how and when to take the medication, how and when to fill in study diaries, how and when to collect sputum samples. Is the patients first point of contact if they have any queries or have a change in medical circumstance. Collects and records information from study visits for sponsors. 1 =Belfast Health and Social Care Trust 2 =University of Ulster 3 =Southern Health and Social Care Trust 4 =Queen University Belfast 5 =Western Health and Social Care Trust 3
5 Our Partners We provide access to clinical trials to patients across all 5 Healthcare Trusts in Northern Ireland. We work with a wide range of Pharmaceutical companies, Clinical research organisations, Universities and other organisations. This is so we can provide an extensive range of studies and provide the highest level of expertise and patient care. Pharmaceutical Companies Almac Group Ltd Aradigm AstraZeneca Bayer Healthcare Boehringer Ingelheim Ltd Chiesi Ltd Celerion Edmond Pharma Roche Gilead Sciences GlaxoSmithKline Harrison Clinical Research Moorfields Pharmaceuticals Mpex Pharmaceuticals, Inc Novartis Omnicare Clinical Research Ltd Parexel International Ltd Pharmaxis Pharmaceuticals Ltd PTC Therapeutics Quintiles Ltd Respicopea Ltd Schering Plough Ltd Synairgen Research Ltd United Biosource Corporation Vectura Group Vertex Pharmaceuticals Worldwide Clinical Trials Universities Queens University Belfast Leeds Teaching Hospitals NHS Trust McGill University Health Centre, Montreal University of Ulster, Belfast 4
6 Getting Involved in Upcoming Studies If I am a patient with a respiratory condition, how do I get involved in a clinical research study? Each study has a criteria list that potential participants must meet if they are to be involved in that study. A member of the team may approach you to ask if you meet the criteria and tell you about the study. This could happen at a clinic appointment or during an in-patient stay. Otherwise you may be contacted by telephone or information may be posted out to you. Physiotherapist Denise Cosgrove taking a spirometry measurement with a patient. Upcoming Trials Taking part in research is voluntary. If you are approached, you will be given an information sheet about that study. You will have time to ask questions about the study and decide whether you would like to take part or not. If you decide not to take part, this will not affect your medical care in any way. If you are happy to take part in a study, you will be asked to sign a consent form. If you change your mind at any stage and would like to drop out of the study, you are free to do so. You do not have to give a reason and your care and treatments will not be affected in any way. We have 9 research studies starting in the next year. These studies will look at medications and therapies for a number of respiratory conditions, including: Cystic fibrosis Bronchiectasis Asthma Chronic Cough If you would like further information on any of our studies, please don t hesitate to contact a member of the research team. Telephone: ext or ext
7 Current Research Closed to Recruitment The following studies are now completed by the NICRN Respiratory Health interest group. They are closed to new patients. A phase III, open-label, randomised trial to evaluate the safety and efficacy of a new inhaled antibiotic for Pseudomonas aeruginosa infection in stable cystic fibrosis patients. Pseudomonas aeruginosa lung infection is linked with cystic fibrosis (CF) and other chronic lung conditions. The body's response to Pseudomonas aeruginosa includes infection, which causes repeated episodes of intense breathing problems. The aim of this study was to test the safety and use of a new inhaled antibiotic for treatment of Pseudomonas aeruginosa lung infection. Patients who finished this study will be given the chance to take part in an extended study for 6 months where they continued to receive the new antibiotics. For this study our recruitment rate was 100%. *At the time of this publication the results of this study were not available. A randomised, double-blind, placebocontrolled phase II study comparing the efficacy and safety of an inhaled anti viral medicine to placebo administered to asthmatic subjects after the onset of a respiratory viral infection for the prevention or attenuation of asthma symptoms caused by respiratory viruses. Exacerbations of asthma are an area of unmet medical need, causing significant illness and amount of healthcare resources used. Up to 85% of asthma exacerbations are caused by respiratory viruses. The aim of this study was to decide the advantage of a new inhaled anti-viral medicine to a placebo. This was given to asthmatic patients after the onset of a respiratory viral infection for the prevention or reduction of asthma symptoms caused by respiratory viruses. For this study our recruitment rate was 117%. *At the time of this publication the results of this study were not available. 6
8 Current Research Closed to Recruitment The efficacy and safety of a mucolytic in the long-term therapy of chronic obstructive pulmonary disease (COPD). Mucolytics are a medicine which improves the symptoms and reduces the time of exacerbations in COPD. The aim of this study was to test the ability of a mucolytic medicine, compared to a placebo. It aimed to reduce the number of acute exacerbations over a 12 month treatment period in patients with moderate to severe COPD. The study checked the results of mucolytic medicine on pulmonary function measurements, symptoms and quality of life. It also tested the long-term safety of the drug. For this study our recruitment rate was 100%. *At the time of this publication the results of this study were not available. A phase II, randomised, double-blind, placebo-controlled, parallel group study to assess the efficacy of 28 day oral administration of a new anti-inflammatory twice daily in patients with bronchiectasis. Bronchiectasis is a disease which causes damage to the airways, causing them to widen and become flabby and scarred. In bronchiectasis airways are unable to clear phlegm and can become infected and inflamed. The main purpose of this study was to examine whether the new anti-inflammatory medicine affects the inflammatory markers in the sputum of your lungs. Information was gathered on the safety of the antiinflammatory and how well it is tolerated by patients. For this study our recruitment rate was 67%. *At the time of publication the results of this study were not available. A phase III multicenter, randomized, parallel group, controlled, double blind study to investigate the safety and efficacy of a new mucolytic medicine over 12 months in the treatment of bronchiectasis. The aim of this study was to test the safety and ability of a new mucolytic medicine in patients with bronchiectasis compared to a placebo. Earlier studies with this treatment in patients with both bronchiectasis and cystic fibrosis have shown positive results in adults and children, when given over periods of up to 12 months. From this study we will learn whether 12 months of treatment with the medicine reduces the number of chest infections bronchiectasis patients may have, by helping clear mucus from their lungs. It will find out if the medicine improves quality of life, amount of antibiotics needed, mucus production, lung function and daytime sleepiness. For this study our recruitment rate was 100%. *At the time of this publication the results of this study were not available. 7
9 Research Collaborations Examples of key research projects. Collaborations between the Belfast Trust, Queens University and University of Ulster. Adherence to treatment in bronchiectasis patients infected with Pseudomonas aeruginosa. Amanda McCullough 1, Dr Michael Tunney 1, Dr Judy Bradley 2,3, Prof Stuart Elborn 1,2, Dr Carmel Hughes 1 We will use this information to see if there are any differences in the number of chest infections, quality of life or beliefs about treatment between those who completed all of their prescribed treatments each day and those who did not. For this study our recruitment rate was 75%. Some patients with bronchiectasis get infections in their lungs caused by the bacteria (bug) Pseudomonas aeruginosa. These infections are usually treated with antibiotics which are sometimes taken with a nebuliser. Patients may also have flare ups of the Pseudomonas aeruginosa infection, known as chest infections. The aim of the study was to find out if taking medication and doing airway clearance physiotherapy as prescribed by the healthcare professional affects how often bronchiectasis patients with Pseudomonas aeruginosa have chest infections. Patients from across Northern Ireland took part in this year-long study. Patients answered questions about their quality of life, beliefs about their treatments and about whether they completed all of their prescribed treatments for bronchiectasis each day. Patients also gave information about the number of times they had taken antibiotics for their bronchiectasis as well as how many times they had been in hospital during the study. 1 =Queens University Belfast 2 =Belfast Health and Social Care Trust 3 =University of Ulster 8
10 Research Collaborations Examples of key research projects Collaborations between the Belfast Trust, Queens University and University of Ulster Facilitating education in pulmonary rehabilitation: The Living Well with COPD Programme for Pulmonary Rehabilitation. Surviving but egregated: Making sense of living with cystic fibrosis and Burkloderia cepacia complex. Dr Denise Cosgrove 1,2, Dr Joseph McMahon 1, Dr Jean Bourbeau 3, Dr Judy Bradley 1,2 and Dr Brenda O Neill 2 The aim of this study was to adapt the self management programme Living Well with COPD (LWWCOPD) so that we could use it during pulmonary rehabilitation programmes in Northern Ireland. This was completed based on feedback from people with COPD, health professionals and from the original authors of the programme. Our study then assessed how effective the LWWCOPD programme for pulmonary rehabilitation was. The study showed that the LWWCOPD programme for pulmonary rehabilitation was useful to deliver the education and information sessions during pulmonary rehabilitaion. Patients and health professionals reported high satisfaction with the content of the programme and the methods used to deliver it. It also showed that patients knowledge, understanding and confidence improved after pulmonary rehabilitation. *This study was granted an award from the Research and Development Office to provide all pulmonary rehabilitation sites in Northern Ireland with a completed copy of the programme and to carry out workshops to train all health professionals in its use. Dr Elaine Davison 1, Dr Kate Russo 4, Dr Amanda Crossan 1 and Prof Stuart Elborn 1,4 This aim of this study was to gain a better understanding of living with cystic fibrosis and Burkloderia cepacia complex in order to help develop a better service for those with Cepacia in the future. Burkholderia cepacia complex, better known as cepacia, is a group of bacteria that can live in the lungs of people with cystic fibrosis. When a patient contracts the bacteria Burkolderia cepacia, they may have to undergo changes to their lifestyle and healthcare. Interviews took place and looked at patients experience of living with cepacia and problems with segregation policies because of cross infection control. The study showed the experiences of those living with cepacia and how patients with cepacia view themselves, their health and how they cope. From a healthcare viewpoint it will give professionals a better understanding of the daily challenges in which patients with cepacia struggle with. 1 =Belfast Health and Social Care Trust 2 =University of Ulster 3 =McGill University Health Centre 4 =Queens University Belfast 9
11 News and Events Lagan River Zip Slide In April 2012 some of our researchers took part in a zip slide across the Lagan River in aid of the Cystic Fibrosis Trust. Some even took to the sky in fancy dress! Over 2.5 k was raised!!! Well done to everyone involved and thank you to everyone who donated generously! We would like to take this opportunity to thank all patients who have participated in our research studies. Without your participation in research, none of our studies would be possible. THANK YOU! 10
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