A study to determine safety and effectiveness of Budesonide-Formoterol given through the Ciphaler device in patients with Asthma.
Not Applicable
Completed
- Conditions
- Health Condition 1: J459- Other and unspecified asthma
- Registration Number
- CTRI/2023/06/053727
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. A voluntarily given written, signed dated informed consent from subjects and/or legally acceptable representative. 2. Subjects of either gender of age 18 years or above with documented diagnosis of Asthma. 3. Subjects receiving Budesonide-Formoterol through the Rotahaler, who have uncontrolled asthma. and in the Investigator’s opinion can be switched to treatment with Budesonide-Formoterol Ciphaler. 4. Subjects able to use Ciphaler correctly during course of the study and able to comply with the study protocol.
Exclusion Criteria
1. Hypersensitivity to study drug or any of its components. 2. Subjects using devices other than Rotahaler. 3. Previous experience with the use of Ciphaler.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method