A study to evaluate Glycopyrrolate and Formoterol Fumarate Inhalation 9 mcg and 4.8 mcg in patients with Chronic Obstructive Pulmonary Disease
- Conditions
- Health Condition 1: J684- Chronic respiratory conditions dueto chemicals, gases, fumes and vapors
- Registration Number
- CTRI/2022/07/043634
- Lead Sponsor
- Zydus Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 < 0.7;
b. Post-bronchodilator FEV1, >= 30% to < 80% predicted
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
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in trough FEV1 at week 4 and week 12 as <br/ ><br>compared to baselineTimepoint: 12 Week
- Secondary Outcome Measures
Name Time Method Change in trough FVC at week 4 and week 12 as compared to baseline <br/ ><br>Change in post-bronchodilator FEV1 and FVC at week 4 and week 12 as compared to baseline <br/ ><br>Change in CATTM score at week 4, 8 and 12 as compared to baseline <br/ ><br>Responder rate at week 4 and week 12 <br/ ><br>Rescue bronchodilator use at week 4, 8 and 12 as compared to baseline (screening period) <br/ ><br>Proportion of patients with COPD exacerbations during the studyTimepoint: on 4, 8 and 12 weeks