Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patient willing to provide signed data sharing consent form. AND 2)Patients of either gender of age 40 years or above with documented diagnosis of COPD as per GOLD 2020 guidelines and CAT score of more than 10 units. AND 3)Patients prescribed formoterol/budesonide FDC through Synchrobreathe inhaler for COPD due to any of the following reason: a) Patient not controlled with current treatment or current ICS/LABA and requires the addition of formoterol/budesonide FDC. b) Unable to use or not satisfied with the previously prescribed inhaler for taking Formoterol/Budesonide FDC. 4)Patients suitable to share data for the study as per Investigator’s discretion
Exclusion criteria
Exclusion criteria: 1)Hypersensitivity to study drug or any of its components. 2)Acute exacerbation of COPD within past 1 month. 3)Current or previous experience with the use of Synchrobreathe.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean CAT scores for COPD at week 12 from baseline.Timepoint: Day-0 to Week-12 | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Change in CAT score at week 4 and 8 from baseline. b) Change in modified Borg dyspnea scale score at week 4, 8 and 12 from baseline. c) Device usability assessment at week 4. d) Adverse Events throughout the observational period of 12 weeks. Timepoint: Week-4, Week 8 & Week-12 | — |
Countries
India
Contacts
Public ContactAbhijit Vaidya
Cipla Ltd
Outcome results
None listed