A study to evaluate the efficacy and safety of Fixed Dose Combination of Glycopyrronium, Formoterol Fumarate, Budesonide in patients with chronic obstructive pulmonary disease.
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
- Registration Number
- CTRI/2023/10/058791
- Lead Sponsor
- upin Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- 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:
• Post-bronchodilator FEV1/FVC ratio < 0.7
• Post-bronchodilator FEV1, = 30% to < 80% predicted
4. COPD Assessment Test (CATTM) score = 10 even after receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) for at least 4 weeks at the time of screening.
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 a1 antitrypsin deficiency
3. Patients diagnosed with COVID-19 in last 3 months
4. COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period
5. Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period
6. Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period
7. Patients who required long-term oxygen therapy (=12 hours/day) within 4 weeks prior to the screening or during the screening period
8. Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention
9. Patients with known hypersensitivity to formoterol glycopyrronium, salbutamol, other beta-2 agonists or other anti muscarinic agents
10. Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy
11. Patients with hepatic dysfunction (serum transaminases = 3 x Upper Normal Limit) or renal dysfunction (serum creatinine = 2.5 mg/dl) at screening
12. Patients with continuing history of alcohol and/or drug abuse
13. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
14. Participation in another clinical trial in the past 3 months
15. Any other reason for which the investigator feels that the patient should not participate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in trough FEV1Timepoint: At 4 weeks & 12 weeks
- Secondary Outcome Measures
Name Time Method 1.Change in trough FVC <br/ ><br>2.Change in post-bronchodilator FEV1 & FVC <br/ ><br>3.Change in CAT score <br/ ><br>4.Responder rate <br/ ><br>5.Proportion of patients with COPD exacerbations during the study. <br/ ><br>6.Rescue bronchodilator use during treatment period. <br/ ><br>Timepoint: At 4 weeks, 8 weeks & 12 weeks;Safety endpoints <br/ ><br>• Adverse events reported during the study <br/ ><br>• Serious adverse events reported during the study <br/ ><br>Timepoint: At 4 weeks, 8 weeks & 12 weeks