Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Budesonide-Formoterol 200/6
mcg or 400/6 mcg: Ciphaler (multidose DPI)
Intervention2: Budesonide-Formoterol 400/6 mcg: CiphalerTM (multidose DPI)
Control Intervention1: Nil: Nil
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Asthma Control Questionnaire-5 (ACQ-5) ScoreTimepoint: At Week 12 from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events throughout the observationalTimepoint: Period of 12 weeks;Assessment of Device usability questionnaireTimepoint: At week 4;Change in Asthma Control Questionnaire-5 (ACQ-5) ScoreTimepoint: At week 4 and week 8 from baseline;Change in PEFRTimepoint: At week 4, week 8 and week 12 from baseline;Proportion of subjects as responders well-controlled, partially controlled, and uncontrolledTimepoint: At week 4, 8 and 12. | — |
Countries
India
Contacts
Public ContactMr Abhijit Vaidya
Cipla Limited
Outcome results
None listed