A real-world non-interventional study to assess patient satisfaction with and preference for re-usable Respimat Soft Mist inhaler in patients with chronic obstructive pulmonary disease

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Evaluation of patient-reported outcomes

  Other
• If ‘other’, further details on the scope of the study:
  Patient satisfaction with inhaler attributes
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  SPIRIVA RESPIMAT

  STRIVERDI RESPIMAT

  SPIOLTO RESPIMAT
• Anatomical Therapeutic Chemical (ATC) code:
  (R03BB04) tiotropium bromide

  tiotropium bromide

  (R03AC19) olodaterol

  olodaterol

  (R03AL06) olodaterol and tiotropium bromide

  olodaterol and tiotropium bromide
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  The study population will include patients (aged 40 and above) with COPD, who are residing in one of the target countries and follow the routine clinical practice of the participant sites. Patients should be prescribed a re-usable Respimat SMI product, during the study period, in the course of standard medical practice. Patients must be able to inhale the medication in a competent manner from the Respimat SMI according to the Clinical investigator's judgement, which will be recorded in the electronic case report form (eCRF) as per standard clinical practice.; Inclusion criteria:; Patients fulfilling all the following inclusion criteria will be eligible for participation in the study:; - Provision of signed informed consent prior to study data collection; - Patient with COPD aged 40 years or older; - Patient prescribed (or already receiving the disposable Respimat SMI and switched to) 1 of the following re-usable Respimat SMI products per the standard clinical practice:; Spiriva 2.5 microgram inhalation solution, Striverdi 2.5 microgram inhalation solution or Spiolto 2.5 microgram / 2.5 microgram inhalation solution; - Patient unlikely to change their Respimat therapy during the observation period (in the opinion of the investigator); Exclusion criteria:; Patients fulfilling any of the following exclusion criteria will not be eligible for participation in the study:; - Patient using a disposable Respimat SMI product during the study period, after study entry; - Patient who have had a severe COPD exacerbation requiring hospitalisation in the immediate 3 months prior to study entry; - Patient participating in a clinical trial or any other non-interventional study of a drug or inhaler at the time of enrolment; - Visual, cognitive, motor or health impairment that, as judged by the investigator, may cause concern regarding the patient's ability to complete the questionnaires; - Patient not fluent and literate in one of the main languages of the country
• Age groups:
  • Adults (46 to < 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:
  250

Study design details

• Study design:
  This was a multi-centre, open-label, prospective, real-world non-interventional study conducted on patients with COPD who received the re-usable Respimat SM
• Main study objective:
  The primary objective of the study is to assess patientsatisfaction with the re-usable Respimat SMI, assessingthe mean total score of the validated Patient Satisfactionand Preference Questionnaire (PASAPQ) at study end.
• Setting:
  Number of sites: 20 overall, from 6 countries (Belgium, Denmark, Finland, Germany, Netherlands, and Norway)
• Outcomes:
  The primary objective of the study is to assess patientsatisfaction with the re-usable Respimat SMI, assessingthe mean total score of the validated Patient Satisfactionand Preference Questionnaire (PASAPQ) at study end. 1. To examine the individual domains of the PASAPQ:total performance score, total convenience score, the overall satisfaction question and the question onwillingness to continue with inhaler at study end2. To examine ease of handling of the re-usableRespimat SMI at study end
• Data analysis plan:
  The total PASAPQ and the domain scores (total performance score, totalconvenience score, overall patient satisfaction score and the rating ofwillingness to continue with the inhaler) will be summarised usingdescriptive statistics for continuous variables.The difference in the mean total PASAPQ score between baseline andstudy end, in Respimat SMI-experienced patients switching from adisposable to a re-usable Respimat SMI product at study entry, will becompared using a two-tailed paired t-test or an appropriate non-parametric test (e.g. Wilcoxon signed ranks test), depending on the distributions of the count / score data.Responses to the questions on the ease of handling of the re-usable Respimat SMI will be summarised using descriptive statistics for categorical or continuous variables, as appropriate.