Study to assess the confidence, usability,preference and satisfaction on use of Zerostat spacer in healthy volunteersand in subjects with mild Asthma or COPD.
Phase 4
Completed
- Conditions
- Health Condition 1: null- Subjects with mild Asthma or COPD or healthy volunteer.
- Registration Number
- CTRI/2014/03/004448
- 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.
Exclusion Criteria
1. Subjects already using Zerostat spacer prior to start of the study.
2. Subjects with co-ordination problems like Parkinsonâ??s disease, mental
illness, tremors etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average time taken for 3 consecutive correct attemptTimepoint: Average time taken for 3 consecutive correct attempt
- Secondary Outcome Measures
Name Time Method Confidence, Usability, Preference and Satisfaction assessmentTimepoint: Throughout the study period;Type and number of errorsTimepoint: During first and second visit