A clinical trial to assess the confidence, usability, preference and satisfaction on use of peak flow master in healthy volunteers and in subjects with mild Asthma or COPD.
Phase 4
Completed
- Registration Number
- CTRI/2009/091/000586
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1.Subjects and healthy volunteers willing to sign informed consent
2.Subjects and healthy volunteers of 18 years and above
3.Subjects with or without a respiratory condition. Each subject with a respiratory condition (prior experience of using an device) should be matched as far as possible with an individual without a respiratory condition (device naïve) with respect to the age, sex, literacy status etc
4.Subjects with mild Asthma or COPD or healthy volunteer.
5.Subjects who are only English speaking
Exclusion Criteria
1.Subjects already using Peak flow master prior to start of the study.
2.Subjects with co-ordination problems like Parkinson?s disease, mental illness, tremors etc.
Study & Design
- Study Type
- Observational
- 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: Between visit-1 and visit-2
- Secondary Outcome Measures
Name Time Method Confidence assessmentTimepoint: Between Visit-1 and Visit-2;Preference assessmentTimepoint: Between Visit-1 and Visit-2;Satisfaction assessmentTimepoint: Between Visit-1 and Visit-2;Type and number of errors during first and second visit.Timepoint: Between Visit-1 and Visit-2;Usability assessmentTimepoint: Between Visit-1 and Visit-2