A clinical study to evaluate Glycopyrronium, FormoterolFumarate and Budesonide DPI 25 mcg, 12 mcg and 400 mcg inpatients with COPD
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
- Registration Number
- CTRI/2022/12/048192
- Lead Sponsor
- Zydus Healthcare Limited
- 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. 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 α1 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: Week 4 and 12
- Secondary Outcome Measures
Name Time Method Adverse events reported during the studyTimepoint: Up to week 12;Change in CATscoreTimepoint: on week 4, 8 & 12;Change in post-bronchodilator FEV1 and FVCTimepoint: On week 4 & 12;Change in trough FVCTimepoint: On week 4 and 12;Proportion of patients with COPD exacerbations during the studyTimepoint: Up to week 12;Rescue bronchodilator use during treatment periodTimepoint: Up to week 12;Responder rateTimepoint: At week 4 & 12;Serious adverse events reported during the studyTimepoint: Up to week 12