Study to assess the confidence, usability, preference and satisfaction on use of Zerostat-VT Spacer in healthy volunteers and in subjects with mild asthama or COPD
Phase 4
Completed
- Conditions
- Health Condition 1: null- subjects with mild asthma or COPD
- Registration Number
- CTRI/2014/02/004432
- 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 ethics committee
approved informed consent form.
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 a device) should be
matched as far as possible with an individual without a respiratory
condition (device naive) 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-VT 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 attempts <br/ ><br>Timepoint: During First and second visit
- Secondary Outcome Measures
Name Time Method Confidence, Usability, Preference, Satisfaction assessmentTimepoint: Throughout the study;Number of attempts required to achieve first correct attemptTimepoint: At baseline and follow-up visit;Type and number of errorsTimepoint: During first and second visit