Overview of the Research
The Respiratory Clinical Trials Unit at BIHR has been conducting clinical trials since 2009. We are fully self funding and are currently recruiting to 13 active phase 2&3 severe asthma trials, 6 phase 3 COPD trials & 1 nasal polyp and severe asthma study. In addition we have successfully recruited into over 60 completed severe asthma and COPD trials. In all the trials we have consistently recruited to our target and even surpassed it. We have had at least 3 Global first patients & several European first recruits into the trials we have conducted. Our site has been audited on numerous occasions by our industry partners. Our unit was inspected by the MHRA in January 2012. The MHRA inspection highlighted the exemplary record keeping at our site and our leadership. Dr Saralaya was one of the leading investigators in a recently concluded real life study looking at the real life effectiveness of Omalizumab in real life UK clinical practise. In addition he has been the collaborator investigator in several COPD and severe asthma trials which have been published in the New England Journal of Medicine in 2014 & 2016. He is an international key opinion leader in severe asthma research. Dr Saralaya has been awarded the best National Principle Investigator award by NIHR on 2 separate occasions in 2015 & 2016 for his consistent delivery into the national respiratory research portfolio. We are a preferred site in the UK for severe asthma and COPD research to our Industry partners.
The research team is supported by 4 Research Nurses, 1 research assistant and 1 study administrator.
We have conducted non-commercial trials for some of the leading universities in the UK with respiratory research, namely:
- University of Portsmouth
- University of Aberdeen
- University of Southampton
- University of Huddersfield
Our Areas of Research include:
Clinical Trials activity :
- COPD: both inhaled and biologics
- Severe Asthma : Biologics and newer inhaler technologies.
- Nasal Polyposis & Asthma : Biologics
We currently have 20 open trials and 3 more in set-up. 8 trials are still in the recruitment phase of which 4 have a target ranging from 2 – 100 patients.
Outstanding success information:
- Dr Saralaya awarded the Best Principal Investigator award by NIHR in 2015 & 2016.
- Global 1st Patient in: 3 COPD trials,,in 2011-13.
- Leading Recruiter in Apex 2 Severe asthma trial in 2014.
- Highly commended for patient involvement strategy
- 80% of commercial trials closed on time, to target in 2015-16
The Research Team
NTHI Mcat-002 – An observer blind study to evaluate the efficacy, safety , reactogenicity and immunogenicity of the GSK Biologicals’ investigational vaccine GSK3277511A when administered to COPD patients.
SINUS – A randomised, 24-week treatment, double-blind, placebo-controlled efficacy and safety study of dupilumab 300 mg every other week, in patients with bilateral nasal polyposis on a background therapy with intranasal corticosteroids
Somosa – Study of Mechanisms of action of Omalizumab in Severe Asthma
205715 – A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual combination of FF/VI, administered once-daily via a dry powder inhaler in subjects with inadequately controlled asthma
KFL3502 – A two-arm, randomized, parallel group study to evaluate the effect of fluticasone/formoterol breath actuated inhaler (BAI) and Relvar Ellipta Dry Powder Inhaler (DPI) on ventilation heterogeneity in subjects with partially controlled or uncontrolled asthma
QAW039A2307 – A 52-week, multicentre, randomised, double-blind, placebo- controlled study to assess the efficacy and safety of QAW039 when added to existing asthma therapy in patients with uncontrolled severe asthma.
PEARL PT010005 – A Randomized, Double-Blind, Multi-Center, Parallel Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD
SOPHOS – A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 compared to PT005 on COPD
Exacerbations over a 52-Week Treatment Period in Subjects With
Moderate to Very Severe COPD
ANDHI – A Multicenter, Randomized, Double-blind, Parallel Group, Placebo‑controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients with Severe Asthma Uncontrolled on Standard of Care Treatment
Throughout our five years of been involved in respiratory research we have many achievements to be proud of these include:
Within 2 years of commencing clinical research we achieved a global first patient first visit in 2011. Since then we have repeated this feat for 3 successive years, between 2011 and 2013.
Dr Saralaya has been invited to be Chief Investigator for two trials, this is a massive privilege and responsibility, as someone relatively new to research this is quite an achievement.
We have often been the highest recruiters on many trials in the UK and have been asked to recruit further patients to a trial to enable the UK to reach its target.
Our progress and achievements have been reported on in the trusts magazine, the local telegraph and even the Yorkshire post. Not only does this inform people of our achievements but advertises respiratory research to all.
Our site has been audited on numerous occasions. We have had a MHRA inspection in January 2012 from which we received a glowing report and were told our documentation was “exemplary”.
We have also had internal audits by the pharmaceutical companies in which we have always had minimal audit findings.
Patient and public involvement
We see patient and public involvement as a very important aspect of our research, and regularly hold events where patient and relatives are invited to voice their opinions or queries. We also take this as an opportunity to disseminate information and use these occasions to improve our service.
We hold our events at locations away from the hospital to enable people to speak openly.
CQAB149B2350-This was the very first trial that respiratory research took part in, as a team we managed to be the highest recruiters in the UK. Our target was to recruit 5 patients and we managed to recruit 11. It was a 12 week treatment, mutlicentre, randomised, parallel group, blinded, double dummy study, to compare the efficacy and safety of Indacaterol delivered via a SDDPPI with Tiotropium delivered via a handihaler, in patients with moderate to severe COPD.
After successfully completing the first trial we then went on to take part in many other COPD trials for Novartis (a swiss-based pharmaceutical company) these included:
We always strive to meet our targets and often exceed these. It is our aim to maintain our high standards at all times.
We have also worked with other well-known companies such as GSK (Glaxo SmithKline, a global healthcare company) on the Zephyr trial and Almirall (International pharmaceutical company) both were COPD trials.
Following these we took on our first asthma trial in 2012 this was the CQAW03A2206- A randomised, placebo-controlled, dose-ranging, multi-centre trial of QAW039 to investigate the effect on FEV1 and ACQ in patients with moderate to severe, persistent, allergic asthma, inadequately controlled with ICS therapy. We managed to recruit 3 patients to this trial which involved 10 visits to clinic over a period of 52 weeks.
- Real-life effectiveness of omalizumab in patients with severe persistent allergic
(IgE-mediated) asthma at a single UK hospital
Simons A, Regan K, Aziz A, Saralaya D, AJRCCM, May 2010.
- Real-life effectiveness of omalizumab in patients with severe persistent allergic (IgE-mediated) asthma: pooled data from three UK centres
Britton M, Howes T, Boland A, Saralaya D, Hepburn D, Nordstrom M, Welham K, Regan K,3 Kasujee , ERJ, September 2011.
- Real-life effectiveness of omalizumab in patients with severe persistent allergic (IgE-mediated) asthma: pooled data from four UK centres
Britton M, Howes T2 Saralaya D, Masoli M, Nordstrom M, Regan K, Hepbur D, Kasujee. ERJ Sept 2012.
- Long-term effectiveness of omalizumab in patients with severe persistent allergic (IgE-mediated) asthma: real-life data from three UK centres
Britton M, Howes T, Saralaya D, Hepburn D, Nordstrom M, Welham K, Regan K,Kasujee
ERJ Sept 2012.
- Improved Metered Dose Inhaler Technique when a co-ordination cap is used
Wahida Azouz, Jessica Campbell, D Saralaya, H Hosker, H Crystyan.
J of Aerosol medicine, Volume 26, Number 0,May 2013.
- Enhanced training on how to use a dry powder inhaler (DPI) improves the inhalation manoeuvre (IM) of patients with asthma (child 6–17yrs and adult >17yrs) or COPD and in healthy adults (HA) when they use a Spiromax® (S) and Turbuhaler® (T) DPI
Azouz W, Chetcuti P, Hosker H, Saralaya D, Chrystyn H
ERJ September 2013.
- Inhalation characteristics with Spiromax®(S) versus Turbuhaler® (T) dry powder inhalers (DPIs) in healthy adults (HA) and in patients with asthma (A) or COPD
Azouz W, Chetcuti P, Hosker H, Saralaya D, Chrystyn H
ERJ September 2013.
- Lung function response to omalizumab in severe allergic asthma in UK clinical practice – APEX II study . Dinesh Saralaya1, Andrew Menzies-Gow2, Ian Clifton3, Adel Mansur4, Alan Hart-Thomas5, Robert Niven6, APEX Study Investigators , ERS 2014.
- Improved Metered Dose Inhaler Technique when a Coordination Cap Is Used
Wahida Azouz, MSc,1 Jessica Campbell, MPharm,1 John Stephenson, PhD,2
Dinesh Saralaya, MD, FRCP,3 and Henry Chrystyn, PhD1
JOURNAL OF AEROSOL MEDICINE AND PULMONARY DRUG DELIVERY
Volume 27, Number 3, 2014
- A prospective observational study of the impact of COPD on daily life following the initiation of indacaterol. Jones PW1, Low EL2, McCaughey M3, Banik AN4, Farley J5, Victory J6, Morjaria JB7, Saralaya D8, Mclain-Smith S2, Uden R2, Qurbain A9, Radwan A9.ERS 2014.
- The impact of indacaterol (Onbrez®) on the daily lives and health status of patienwith COPD: interim results. Authors: Jones PW1, Saralaya D2, Morjaria JB3, Quadrino T4, Qurbain A5.
- The inhalation characteristics of patients when they use different dry powder
Wahida Azouz, PhD, Phd, Philip Chetcuti, MB ChB FRCP , Harold SR Hosker, MB ChB FRCP, Dinesh Saralaya, MD FRCP, John Stephenson, PhD, Henry Chrystyn PhD.
- Impact of omalizumab on treatment of severe allergic asthma in UK clinical practice: a UK multicentre observational study (the APEX II study).
BMJ Open. 2016 Aug 9;6(8)
- Early bronchodilator action of glycopyrronium versus tiotropium in moderate-to-severe COPD patients: a cross-over blinded randomized study (Symptoms and Pulmonary function in the moRnING).
Int J Chron Obstruct Pulmon Dis. 2016 Jun 28;11:1425-34
- Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD.
N Engl J Med. 2016 Jun 9;374(23):2222-34.
- Mepolizumab treatment in patients with severe eosinophilic asthma.