A device handling study comparing two dry powder inhalers in Asthma and COPD.
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecifiedHealth Condition 2: J459- Other and unspecified asthma
- Registration Number
- CTRI/2023/01/048837
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
1. Voluntarily given signed dated Informed consent from subjects.
2. Subjects of 18 years and above with history of asthma or COPD for more than 6 months prior to screening.
3. Subjects with asthma or COPD who are device naïve or those using BAI, pMDI or pMDI + spacer.
4. Subjects naïve to Ciphaler™ and Rotahaler® use.
5. Subjects naïve to any other DPIs for 6 months prior to screening.
6. Subjects able to read PIL.
1. Subjects who are hypersensitive to placebo or its constituents.
2. Subjects with any condition that affected the subject’s ability to operate the inhaler such as cognitive or musculoskeletal or neurological conditions (myopathy or neuropathy causing muscle weakness of the upper limbs, tracheostomy and impaired mental status, rheumatism, eye disorder, dementia, and finger disorder or injury).
3. Subjects ineligible to use a DPI in Investigator’s opinion.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method