Status: Planned First registered on: 25/05/2020
Last updated on: 25/05/2020
1. Study identification
EU PAS Register NumberEUPAS35439
Official titleComparative safety of extrafine beclometasone fixed dose combinations (FDC) and fluticasone FDC in COPD
Study title acronym
Study typeObservational study
Brief description of the studyA historical cohort study, comparing time to pneumonia events in patients with COPD who initiated a fixed dose combination containing beclometasone (Fostair® or Trimbow®) with • Patients initiating a fixed dose combination containing fluticasone • Patients initiating a long-acting bronchodilator The primary outcome is time until a pneumonia event. The secondary outcome is time until a respiratory infection. The following exploratory outcomes will be used: Time until the first pneumonia related hospitalisation: a primary care recorded hospital admission within one month of a physician diagnosed pneumonia Time to first primary care recorded hospital admission. The rate of moderate/severe COPD exacerbations and pneumonia events during the entire follow-up period (to be used for a benefit/harm comparison). A set of confounding handling approaches will be evaluated, and the best one with regard to residual bias will be chosen. Superiority will be tested in a per protocol analysis comparing the FDC beclomethasone group with the FDC fluticasone reference group, with a superiority margin of 10% (or loge(1.1) on the log scale). Patients will be censored at the end of data availability (due to leaving the practice, or the last time data were extracted for the practice), 4 weeks after the last prescription containing ICS or 4 weeks after the patient switches to the comparator medication. This four-week period is to ensure we will capture a pneumonia event, even if early symptoms have caused discontinuation of ICS or switching to the other medication. Non-inferiority will be tested in per protocol analyses comparing the FDC beclometasone group with the LABD reference group, with a non-inferiority margin of a relative difference of 15%. Patients will be censored at the end of data availability (due to leaving the practice, or the last time data were extracted for the practice) or on addition of an ICS.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsOPRI Pte Ltd
Department/Research groupObservational and Pragmatic Research Institute Pte Ltd
Organisation/affiliationOPRI Pte Ltd
Website/Homepagewww.opri.sg
Details of (Primary) lead investigator
Title Professor
Last name Price
First name David
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/04/2020
Start date of data collection01/06/2020
Start date of data analysis01/07/2020
Date of interim report, if expected01/09/2020
Date of final study report31/10/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesChiesi pharmaceuticals, Italy100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 15a Coles Lane
Address line 2Oakington 
Address line 3 
CityCambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom
Phone number (incl. country code)441223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@rirl.org
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 15a Coles Lane 
Address line 2Oakington 
Address line 3 
CityCambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom 
Phone number (incl. country code)441223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@rirl.org 
Top