Characterising patients and examining real-life outcomes for UK patients with COPD initiating on or changing to Fostair (REACH II)

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:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Historical cohort database study

Study drug and medical condition

• Name of medicine, other:
  Fostair pMDI
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  Clinician diagnosed COPD (confirmed by spirometry: FEV1/FVC <0.7); Age ≥35 years at index date; Two years of continuous practice data comprising 1-year baseline data and 1-year outcome data; ≥2 prescriptions of the same licensed FDC ICS/LABA (including the prescription on index date) during the outcome period [Fostair® pMDI, Seretide® 500 Accuhaler®, Symbicort® 200 Turbohaler®, and Symbicort® 400 Turbohaler®]; ≥1 prescription of LABA and/or LAMA (with or without an ICS alone) and/or a FDC ICS/LABA therapy during a 2-year period prior to the index date; ≥1 moderate to severe COPD exacerbation during an 18-month period preceding index date OR ≥1 moderate to severe COPD exacerbation preceding index date ever; FEV1 <55% predicted recorded ever.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Chronic obstructive pulmonary disease (COPD) patients
• Estimated number of subjects:
  80000

Study design details

• Main study objective:
  To evaluate whether beclomethasone/formoterol (Fostair pMDI) is non-inferior in terms of COPD exacerbation prevention, to other fixed dose combination inhaled corticosteroid/long-acting beta agonist COPD therapies.
• Outcomes:
  The proportion of patients with no COPD exacerbations in the outcome period. Respiratory outcomes for Fostair pMDI relative to other COPD therapies considered (please see full protocol for details) and cost-effectiveness outcomes for Fostair pMDI relative to other COPD therapies considered (please see full protocol for details)
• Data analysis plan:
  Statistically significant results will be defined as p<0.05 and trends as 0.05≤p<0.10Summary statistics will be produced for all baseline and outcome variables, as a complete dataset and by therapy. Treatment groups will be compared using t-test / Mann Whitney U-test (depending on distribution) for variables measured on the interval/ratio scale and using a chi square test for categorical variables.Outcomes analyses: patients may be matched on demographics and key measures ofdisease severity to minimise confounding, using random selection process through SAS statistical software to avoid selection bias.To show non-inferiority in exacerbation prevention, the adjusted proportions of patients within each treatment group, recording no exacerbations in the outcome period will be calculated using a generalised linear model with binomial distribution and logit link.95% confidence interval will be reported.