Health Condition 1: null- Patient with COPD
Conditions
Interventions
Intervention1: Ciclesonide,Formoterol,Tiotropium FDC (Triohale®): Dry Powder Inhaler (Ciclesonide 400mcg- Formoterol 12mcg - Tiotropium 18 mcg)-
1 Rotacap OD through oral route, for 24 weeks. Metere
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient is ready to sign informed consent form 2. Patients of either sex above 40 years of age with a confirmed diagnosis of COPD (GOLD updated January 2014) 3. Patient able to use the Revolizer or Rotahaler dry powder inhaler, pMDI or pMDI with spacer and perform the Spirometry. 4. Triohale®/triple therapy naïve patients who are assessed to benefit from the intake of Triohale® (Investigator adjudicated need to step-up to triple therapy due to increased symptoms or clinical deterioration or frequent exacerbation).
Exclusion criteria
Exclusion criteria: 1. Patient Known or suspected hypersensitivity to combination or any other constituents of the Investigational Medicinal Product (IMP) & study drugs. 2. Actively participating in any clinical trial or participated in past 1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in the pre-dose value of forced expiratory volume in first second (FEV1) from baseline to the end of the 24 week treatment periodTimepoint: Baseline to the end of the 24 week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| All drug related or non-related AEs and SAEs will be documented.Timepoint: Throughout the study period;Mean change in post dose values of FEV1Timepoint: Baseline to subsequent visits;Mean change in pre & post dose values of FVCTimepoint: Baseline to subsequent visit;Mean change in the CAT score from baselineTimepoint: At 4, 8, 12, 18 and 24 weeks;Mean change in the mMRC score from baselineTimepoint: At 4, 8, 12, 18 and 24 weeks;Mean change in the pre dose value of FEV1 from baselineTimepoint: At week 4, 8, 12 and 18 weeks;Number of exacerbations recordedTimepoint: At the end of the 24 weeks treatment # mild (requiring new prescription of bronchodilator only), # moderate (requiring antibiotics and/or oral steroids) # severe exacerbations (requiring hospitalization);Questionnaire on satisfaction of triple therapyTimepoint: recorded at the end of 4 weeks | — |
Countries
India
Contacts
Public ContactMr Satish Marukurti
Cipla Ltd.
Outcome results
None listed