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: 

COPD

Asthma

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