Real life assessment of chronic obstructive pulmonary disease Inhaler devices handling (INHALER)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Other
• If ‘other’, further details on the scope of the study:
  Handling of medical devices
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  General practitioners (GPs) and pulmonologists were recruited to participate in the study using paper mail or emails sent to all non-hospital-based pulmonologists and a random sample of GPs. They were asked to recruit patients above the age of 40 years, current or ex-smokers of ⩾10 pack-years, who had been using an inhaler device for more than 1 month for continuous treatment of COPD. Physicians asked their COPD patients using any of the six most common inhalers to come to the next visit with their own inhaler. They were requested to take a puff of their usual inhaler with their usual inhalation technique, which was observed and rated by the physician. Physicians were asked not to give any instructions before the test and to pay attention particularly to dose preparation and delivery.
• 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:
  5000

Study design details

• Main study objective:
  The objective is to assess COPD patient handling with their usual inhaler (Breezhaler®, Handihaler®, Diskus®, pMDI, Respimat® or Turbuhaler®) in real-life by general practitioners or pulmonologists.
• Data analysis plan:
  Statistical analysis will provide a description of the selection of physicians and patients in the study, the characteristics of physicians, the characteristics of patients included the handling of each COPD inhaler device, the handling error rate of the COPD inhaler devices, the characteristics of patients presenting a handling error for each type of error.Statistical analysis will be performed after database lock using SAS® software. The descriptive analysis of qualitative and ordinal variables will be presented using the frequency and the proportion of each modality. Quantitative variables will be presented using the size, number of patients with missing data, the arithmetic mean, standard deviation, the first quartile, median, third quartile, and extreme values. Two-sided 95% confidence intervals (CI) will be assessed for the error rates. The CIs will be calculated using normal approximation, exact binomial or Poisson method according to the size of samples.