Status: Ongoing First registered on: 30/05/2017
Last updated on: 30/05/2017
1. Study identification
EU PAS Register NumberEUPAS19323
Official titleEffectiveness of triple therapy vs. dual bronchodilation in COPD
Study title acronymEffectiveness of triple therapy in COPD
Study typeObservational study
Brief description of the studyMost patients with COPD can be managed using long-acting bronchodilators. Triple therapy – inhaled corticosteroids (ICS) with long-acting muscarinic antagonist and beta agonist (LAMA+LABA) - is the most intensive type of treatment, but it is uncertain whether patients do better on triple therapy [TT] compared to therapy with two bronchodilators only. More evidence is needed so that clinicians can make informed treatment decisions for their patients. The study aims to examine whether the effectiveness, in terms of reducing COPD-related exacerbations and loss of lung function, of triple therapy is superior to that of dual bronchodilation (LAMA+LABA) in patients with COPD. In addition, the potential heterogeneity of the effectiveness driven by patient’s and therapy characteristics will be studied. The study uses a historic cohort design, and matches the patients between treatment groups, according to relevant demographic and clinical characteristics using information from anonymous primary care records of COPD patients. Two designs will be used to study the effectiveness of TT in COPD patients with a history of smoking: A. Patients who step-up from LAMA+LABA to TT will be compared with patients who remain on LAMA+LABA B. Patients who step-up from LAMA to TT will be compared with patients who step up to LAMA+LABA Primary outcomes will be the occurrence of COPD exacerbations (number in first year and time to first event) and the average decline in forced expiratory volume in first second [FEV1] per year during follow-up. A one year baseline period is used to identify variables for matching, and patients are followed up during an outcome period of at least one year. Exacerbations will be compared using conditional negative binomial regression to estimate the adjusted rate ratios with 95% confidence intervals. Stratified Cox regression will be used to compare the time to first exacerbation and a multilevel regression model to analyse change in FEV1 over time.
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 signed01/05/201701/05/2017
Start date of data collection15/05/201715/05/2017
Start date of data analysis01/06/2017
Date of interim report, if expected
Date of final study report01/08/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesChiesi100
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)44-1223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address marjan@opri.sg
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)44-1223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address marjan@opri.sg 
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