Exploratory study identifying the benefits of pMDI versus Diskus for delivering fluticasone/salmeterol combination therapy in patients with chronic obstructive pulmonary disease (COPD)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Seretide Evohaler, Seretide Accuhaler
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

  Pneumonia

  Diabetes mellitus

  Oral candidiasis

  Lower respiratory tract infection

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  (1) Characterising patients with COPD on fluticasone/salmeterol combination therapy via pMDI and Diskus.(2) Identifying and comparing the potential benefits of using pMDI versus Diskus in the delivery of fluticasone/salmeterol combination therapy in terms of both efficacy and adverse events.
• 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 device. For variables measured on the interval or ratio scale, these will include:Sample size (n) & percentage non-missingMean & Variance / Standard DeviationRange (Minimum / Maximum)Median & Inter-quartile Range (25th and 75th percentiles)For categorical variables, the summary statistics will include:Sample size (n)Range (if applicable)Count and Percentage by category (distribution)Treatment arms 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.