Lead Investigator: Thomas Antalffy, Smart Respiratory Products Ltd
Title of Proposal Research: Analysing Clinical Applicability of CompEx Endpoints
Vivli Data Request: 7495
Funding Source: Self-funded by Smart Respiratory Products Ltd
Potential Conflicts of Interest: None
Summary of the Proposed Research:
CompEx is a very well researched and promising endpoint for asthma exacerbations developed to accelerate clinical development. The CompEx events recommended by the authors are 2.78 times more frequent than severe exacerbations. The same CompEx endpoints could be very useful in clinical practice. The only immediately obvious factor hindering clinical introduction is the fact that compliance with keeping detailed asthma diaries is much lower in the general asthma population than in trial participants. A secondary factor is the well-known phenomenon of patients fabricating asthma diary data. Our research intends to revisit the CompEx dataset to determine the impact of patient non-compliance on the number of CompEx events detected.
Requested Studies:
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
Data Contributor: AstraZeneca
Study ID: NCT01238861
Sponsor ID: MI-CP220
A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma. (NIMBUS)
Data Contributor: AstraZeneca
Study ID: NCT01704495
Sponsor ID: D3551C00001
Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 mg
Data Contributor: AstraZeneca
Study ID: NCT00242775
Sponsor ID: D5890C00002
Study to Investigate the Efficacy of Symbicort® SMART. (SAKURA)
Data Contributor: AstraZeneca
Study ID: NCT00839800
Sponsor ID: D589LC00001
AstraZeneca study 1
Data Contributor: AstraZeneca
Sponsor ID: D5890C00667
AstraZeneca study 2
Data Contributor: AstraZeneca
Sponsor ID: D5890C00668
AstraZeneca study 3
Data Contributor: AstraZeneca
Sponsor ID: D5890C00673
AstraZeneca study 4
Data Contributor: AstraZeneca
Sponsor ID: D5890C00734
AstraZeneca study 5
Data Contributor: AstraZeneca
Sponsor ID: D5890C00735