To test usability of Tiotropium Bromide device of Cipla limited in Indian adult subjects with respiratory diseases
- Conditions
- Health Condition 1: - Health Condition 2: J449- Chronic obstructive pulmonary disease, unspecifiedHealth Condition 3: J398- Other specified diseases of upperrespiratory tract
- Registration Number
- CTRI/2020/08/027463
- Lead Sponsor
- Cipla Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1)Male and female adult subjects of any ethnic origin, aged 40 years and above.
2)Subjects willing to provide signed and dated written informed consent voluntarily.
3)Subjects who can read, understand and converse in English.
4)Subjects with stable COPD based on investigatorâ??s discretion.
5)Subjects who have not taken part in any market research or a clinical trial related to a pharmaceutical product or a medical device in the past one month.
6)Subjects who can use the inhaler independently.
1)Subjects with co-ordination problems like Parkinsonâ??s disease, mental illness, tremors etc.
2)Subjects having medical history of intolerance to milk and other dairy products, and/or confirmed physician diagnosis of lactose intolerance.
3)Subjects who are judged suspicious by the investigator for coronavirus disease 2019 (COVID-19) based on the screening questionnaire for COVID-19.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method