Health Condition 1: J688- Other respiratory conditions due to chemicals, gases, fumes and vapors
Conditions
Interventions
Intervention1: INDACATEROL/GLYCOPYRRONIUM: Indacaterol/Glycopyrronium in comparison with Formoterol/Tiotropium in assessing efficacy and safety in patients with mild to modearte COPD. Group 1 will be
Sponsors
PGIMS Rohtak
Monika verma
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both male and female adults aged 40 years and abovewith clinical diagnosis of mild to moderate COPD according to GOLD Criteria. 2. Confirmed post-bronchodilator spirometry criteria of FEV1 50-70%and FEV1/FVC 3. All patients will be needed to be symptomatic for inclusion, classified as CAT total score 4. Smokers with a smoking history of at least 10 pack years. 5. Stable and symptomatic, fresh and old cases will be taken. 6. Patient who will agree to sign written informed consent prior to participation. 7. Patient who will accept to comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Patient suffering from asthma, allergic rhinitis. 2. COPD exacerbations 4 weeks before screening. 3. Other Cardiovascular conditions like myocardial infarction, heart failure, severe cardiac arrhythmia requiring treatment within last 6 weeks. 4. Patient with lung cancer, active tuberculosis, interstitial lung disease. 5. Patient with narrow angle glaucoma requiring drug therapy. 6. Known symptomatic prostatic hypertrophy requiring drug therapy or operation. 7. Women who are pregnant and nursing. 8. Patients suffering with liver or renal dysfunction. 9. Prior hospitalization in last one month that required treatment with antibiotics and corticosteroids. 10. Patients with a current or recent (within the past 4 weeks) acute serious illness, acute psychiatric illness. 11. Any history of allergy to study medication. 12. Patients vaccinated with live attenuated vaccines within 2 weeks prior to screening visit or during run-in period. 13. Patient who use oxygen therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung functions (PFT) TDI focal scoreTimepoint: PFT at baseline, 0 min, 15 min, 1hour, 6hour and 24 hour to assess short term efficacy and then at 4,8 and 12 weeks to assess long term efficacy. TDI focal score at baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.COPD assessment test 2.exacerbation frequency and severity 3. need for rescue medication (duration and number)Timepoint: 4,8 and 12 weeks | — |
Countries
India
Contacts
Public ContactMonika Verma
PGIMS ROHTAK
Outcome results
None listed