Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Salmeterol-Fluticasone through Ciphaler TM for uncontrolled COPD while they had been on
same combination delivered through DPI/pMDI.: Subjects will be given Seroflo Ciphaler TM Salmeter
Sponsors
Dr M k Gupta
Eligibility
Inclusion criteria
Inclusion criteria: Volunteers must fulfil all of the following criteria to be considered for inclusion into this study: 1 A voluntarily given written, signed dated informed consent from subjects and/or legally acceptable representative. 2 Subjects of either gender of age 40 years or above with documented diagnosis of COPD as per GOLD 2025. 3 Subjects receiving Salmeterol-Fluticasone through the DPI/pMDI, who are unable to use DPI/pMDI, have uncontrolled COPD (CAT) and that require to switch treatment to Salmeterol-Fluticasone Ciphaler TM . 4 Subjects able to use Ciphaler TM correctly during course of the study and able to comply with protocol.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate disease control and device usability of Salmeterol/Fluticasone delivered through Ciphaler in COPD patients.Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events throughout the observational periodTimepoint: 12 weeks;Change in COPD Assessment Test (CAT) ScoreTimepoint: 4, 8 and 12 weeks;Assessment of Device usability questionnaire at the start and at weekTimepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDr M K Gupta
AANCH Hospital
Outcome results
None listed