Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified Health Condition 2: null- Chronic Obstructive Pulmonary Disorder (COPD) and Asthma-COPD Overlap Syndrome (ACOS)
Conditions
Interventions
Intervention1: AIRZ (Glycopyrrolate) 50 mcg DPI capsule
Airtec FB (Formoterol/Budesonide) DPI capsule: Glycopyrrolate 50 mcg, single dose (Morning) as add on to ICS/LABA inhalation (given Morning & Ev
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed Patients aged >=40 years with COPD or ACOS diagnosis according to the current GINA/GOLD strategy who are symptomatic with >=1 exacerbation in the last year o In case ACOS, post-bronchodilator response improvement in FEV1 should be > 12% with 200 ml increase 2. Patients who have symptomatic stable moderate to severe COPD diagnosis with post-bronchodilator FEV1/FVC ratio 3. >=10 pack years of smoking or biomass/household chullah/occupational dust exposure for >=10 years 4. Patients who have no exacerbation within last 4 weeks 5. Females patients with childbearing potential using effective birth control method 6. Patients who signed written informed consent prior to participation 7. Patients who accept to comply with the requirements of the protocol
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to drugs contains anticholinergics, beta-adrenergic, lactose 2. Diagnosis of asthma 3. Patients vaccinated with live attenuated vaccines within 2 weeks prior to screening visit or during run-in period. 4. Patients who had COPD exacerbation or lower respiratory tract infections that required antibiotic, oral or parenteral corticosteroid treatment within 4 weeks prior to screening visit or during run-in period. 5. Patients who have a history of myocardial infarction, heart failure, acute ischemic coronary disease or severe cardiac arrhythmia requiring treatment within last 6 weeks 6. Patients with concomitant pulmonary disease, eg, pulmonary tuberculosis (unless confirmed by imaging to be no longer active) or clinically significant bronchiectasis, sarcoidosis and interstitial lung disorder 7. Patients who use oxygen therapy 8. Patients with active liver disease or hepatic dysfunction (AST and/or ALT >3 x ULN) or Patients with nephrotic syndrome or renal insufficiency (sr. creatinine >1.5 mg/dl) 9. Women who are pregnant or nursing 10. Known symptomatic prostatic hypertrophy requiring drug therapy or operation 11. Patients with narrow-angle glaucoma requiring drug therapy 12. Patients receiving oral xanthines including theophylline, acebrophylline, deriphylline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Trough FEV1 improvementTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage CAT score improvementTimepoint: 4 weeks and 12 weeks;Treatment Emergent Adverse Events (TEAEs)Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr K Krishnaprasad
Glenmark Pharmaceuticals Ltd.
Outcome results
None listed