Effectiveness of triple therapy vs. dual bronchodilation in COPD (Effectiveness of triple therapy in COPD)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/19324
• EU PAS number:
  EUPAS19323
• Study ID:
  19324
• Official title and acronym:
  Effectiveness of triple therapy vs. dual bronchodilation in COPD (Effectiveness of triple therapy in COPD)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Most 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+LABAB. Patients who step-up from LAMA to TT will be compared with patients who step up to LAMA+LABAPrimary 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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 01/05/2017

Actual: 01/05/2017

Study start date

Planned: 15/05/2017

Actual: 15/05/2017

Data analysis start date

Planned: 01/06/2017

Date of final study report

Planned: 01/08/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Chiesi

Study protocol

Initial protocol

170526_OPRI Study protocol Triple Therapy study Chiesi_V1.1

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable