HANDLING USI20 Study: Satisfaction assessment and Good Usage Practice of RS01® versus Handihaler® inhalers in patients with COPD, a randomized comparative multicenter study
Phase 3
- Conditions
- Respiratory
- Registration Number
- PACTR202008893896971
- Lead Sponsor
- OPALIA pharma RECORDATI Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 87
Inclusion Criteria
Age ? 18 years old
Informed consent, read and signed
Patient with COPD
No previous use of any of the study devices
Exclusion Criteria
Consent not signed
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A satisfaction questionnaire was developped based on 20 items and administrated to the population study after using of the RS1 or the Handihaler inhalers. The primary endopoint is a quantitative criterion defined by of the number of subjects who had a final score = 80% iassessment questionnaires.
- Secondary Outcome Measures
Name Time Method Mean score of the satisfaction questionnaire for each trial group