COMParative clinical effectiveness of FostAIR (extrafine beclomethasone/formoterol) as maintenance and reliever therapies in adult patients with asthma (CompAIR)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Fostair
• Study drug International non-proprietary name (INN) or common name:
  BECLOMETASONE DIPROPIONATE

  FORMOTEROL FUMARATE DIHYDRATE
• Anatomical Therapeutic Chemical (ATC) code:
  (R03AK08) formoterol and beclometasone

  formoterol and beclometasone
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  The study will use the Optimum Patient Care Research Database (OPCRD) to identify adults (≥18 years) with a diagnosis of asthma and no other additional chronic respiratory condition who initiated Fostair or Symbicort as MART for the first time from July 2012 (i.e. when Fostair was first introduced). Index date will be the date of initiating Fostair or Symbicort with at least 12 months registration at the relevant GP surgery. Individuals will be propensity score weighted such that the chosen characteristics of the individuals are the same in each of the treatment groups.
• Age groups:
  Adult and elderly population (≥18 years)
• Special population of interest, other:
  People living with asthma
• Estimated number of subjects:
  78938

Study design details

• Study design:
  Historical cohort study using the Optimum Patient Care Research Database (OPCRD).
• Main study objective:
  Determine whether Fostair® is at least equivalent (non-inferior) to Symbicort® for MART for exacerbation prevention in adults with asthma. ; ; ; ;
• Setting:
  This is a historical cohort study using the Optimum Patient Care Research Database (OPCRD). The OPCRD is an electronic primary care record database covering more than 1,000 GP surgeries across England, Scotland, Wales and Northern Ireland.
• Comparators:
  The study population (i.e. people taking Fostair) will be compared with people taking Symbicort using the same inclusion/exclusion criteria.
• Outcomes:
  (1) Non-inferiority of severe exacerbation rates (primary aim), asthma control (secondary aim) and persistence (secondary aim) is defined as inferiority of no more than 10% at the 2.5% (one-sided probability).; (2) Overall asthma control; (3) Persistence; (4) Number and timing of SABA inhalers and total greenhouse gases associated with SABA
• Data analysis plan:
  The baseline characteristics of the study (Fostair) and control (Symbicort) populations will be described in accordance with the inclusion/exclusion criteria before and after propensity score methods to balance characteristics. Binary outcomes (asthma control, persistence) will be compared using logistic regression and exacerbation rates using negative binomial regression. Estimates of greenhouse gas emissions will be derived from the number of SABA inhalers used and will be descriptive only.
• Summary results:
  Preliminary findings from this study will be presented at the European Respiratory Society (ERS) Conference in February 2025. The work will be published in a peer-reviewed journal in August 2025.