A clinical study to evaluate the efficacy and safety of Indacaterol and Budesonide Powder for Inhalation in patients with Chronic Obstructive Pulmonary Disease.
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
- Registration Number
- CTRI/2021/10/037044
- Lead Sponsor
- Zydus Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 340
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. Clinically stable COPD within 4 weeks prior to the screening visit and during the screening period
5. COPD Assessment Test (CATTM) score � 10 at screening
6. Patients with absolute eosinophil count > 100 cells/mcl
7. Patients with history of at least one moderate exacerbation in last one year
8. Written informed consent from the patient
9. 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 diagnosed with COVID-19 in last 3 months
3. Patients with known �±1 antitrypsin deficiency
4. Patients not on stable doses of LABA/LAMA since last 4 weeks
5. Patients who have used ICS in last 4 weeks
6. COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period
7. Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period
8. Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period
9. Patients who required long-term oxygen therapy (�12 hours/day) within 4 weeks prior to the screening or during the screening period
10. Patients with known hypersensitivity to formoterol, Indacaterol, salbutamol or other beta-2 agonists
11. Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy
12. Patients with hepatic dysfunction (serum transaminases � 3 x Upper Normal Limit) or renal dysfunction (serum creatinine � 2.5 mg/dl) at screening
13. Patients with continuing history of alcohol and/or drug abuse
14. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
15. Participation in another clinical trial in the past 3 months
16. 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 FEV1 at week 12 as compared to baselineTimepoint: Week 12
- Secondary Outcome Measures
Name Time Method Adverse events / Serious adverse events reported during the studyTimepoint: Week 4, Week 8 and Week 12;Change in CATTM score at week 4, 8 and 12 as compared to baselineTimepoint: Week 4, Week 8 and Week 12;Change in post-bronchodilator FEV1 and FVC at week 4 <br/ ><br>and week 12 as compared to baselineTimepoint: Week 4 and Week 12;Change in trough FEV1 at week 4 as compared to <br/ ><br>baselineTimepoint: Week 4;Change in trough FVC at week 4 and week 12 as <br/ ><br>compared to baselineTimepoint: Week 4 and Week 12;Overall tolerability evaluation at the end of studyTimepoint: Week 12;Proportion of patients with COPD exacerbations during the studyTimepoint: Week 4, Week 8 and Week 12;Rescue bronchodilator use at week 4, 8 and 12 as compared to baseline (screening period)Timepoint: Week 4, Week 8 and Week 12;Responder rate at week 4 and week 12Timepoint: Week 4 and Week 12