Health Condition 1: J684- Chronic respiratory conditions dueto chemicals, gases, fumes and vapors
Conditions
Interventions
Intervention1: Glycopyrrolate and Formoterol Fumarate Inhalation 9 mcg and 4.8 mcg: All patients need to take two inhalations of the MDI (Glycopyrrolate and formoterol fumarate inhalation 9 mcg and 4.
Sponsors
Zydus Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either sex between 40-65 years of age (both inclusive) 2.Patients who are current/ex-smokers 3.Patients diagnosed with moderate to severe COPD as per the GOLD guidelines classification at screening visit: a. Post-bronchodilator FEV1/FVC ratio b. Post-bronchodilator FEV1, >= 30% to 4.Clinically stable COPD within 4 weeks prior to the screening visit and during the screening period 5.Written informed consent from the patient 6.Patients literate enough to fill the diary card and willing to comply with the protocol requirements
Exclusion criteria
Exclusion criteria: 1. Patients suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc. 2. Patients with known alpha1 antitrypsin deficiency 3. COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period 4. Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period 5. Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period 6. Patients who required long-term oxygen therapy ( greater or equal to 12 hours/day) within 4 weeks prior to the screening or during the screening period 7. Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention 8. Patients with known hypersensitivity to formoterol, glycopyrronium, salbutamol, other beta-2 agonists or other anti-muscarinic agents 9. Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy 10. Patients with hepatic dysfunction (serum transaminases greater or equal to 3 x Upper Normal Limit) or renal dysfunction (serum creatinine greater or equal to 2.5 mg/dl) at screening 11. Patients with continuing history of alcohol and/or drug abuse 12. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception 13. Participation in another clinical trial in the past 3 months 14. Any other reason for which the investigator feels that the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in trough FEV1 at week 4 and week 12 as compared to baselineTimepoint: 12 Week | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in trough FVC at week 4 and week 12 as compared to baseline Change in post-bronchodilator FEV1 and FVC at week 4 and week 12 as compared to baseline Change in CATTM score at week 4, 8 and 12 as compared to baseline Responder rate at week 4 and week 12 Rescue bronchodilator use at week 4, 8 and 12 as compared to baseline (screening period) Proportion of patients with COPD exacerbations during the studyTimepoint: on 4, 8 and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Zydus Lifesciences Limited
Outcome results
None listed