A study to assess ease of use of a novel inhaler device.
Not Applicable
- Registration Number
- CTRI/2016/04/006838
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1 A written, signed and dated informed consent from all participants/ legally acceptable representatives will be obtained before start of study procedures,
2 Healthy volunteers (having no significant major organ disease)
3 Either gender with age between 30 and 65 years (both inclusive).
Exclusion Criteria
1. Previous experience or current use of any inhaler device
2. History of asthma or COPD or diabetes mellitus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average time taken for three consecutive correct attempts during the first and second visit.Timepoint: Throughout the study
- Secondary Outcome Measures
Name Time Method Device rating scoreTimepoint: At 2nd visit;Number of errors during both visitsTimepoint: Throughout the study;Number of training sessions and attempts required to perform the inhalation technique correctly during the first and second visitTimepoint: Throughout the study;Percentage of participants who use the novel inhaler device without errors and without retraining at 2nd visitTimepoint: At 2nd visit;Types of errors.Timepoint: Throughout the study