An open label, phase IV trial of Glycopyrronium/Formoterol/Budesonide (25mcg/12mcg/400mcg) fixed dose triple combination (FDC) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecifiedHealth Condition 2: J439- Emphysema, unspecified
- Registration Number
- CTRI/2021/08/035992
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. A voluntarily given, written, signed, and dated informed consent from subject and/or legally acceptable representative.
2. Subjects of either gender and age between 40 and 75 years (both inclusive).
3. Subjects with a documented history of COPD (GOLD 2020 guidelines)-based on spirogram within past one year from screening.
4. Post-bronchodilator FEV1 greater than or equal to 30% and less than or equal to 80% of the predicted normal value.
5. Post-bronchodilator FEV1/FVC ratio of less than 0.7.
6. Subjects with CAT score greater than 10.
7. Current or ex-smoker of at least 10 pack years of cigarette/ biddi smoking or subjects who had exposure to noxious stimuli which led to development of COPD.
8. Subjects having ability to use Revolizer® during course of the study and able to comply with protocol.
1. Hypersensitivity to glycopyrronium or formoterol or budesonide or levosalbutamol or any of its components.
2. Subjects with any hospitalization required for severe exacerbation or any serious condition within past 12 weeks from screening.
3. Subjects requiring oral/parenteral corticosteroids within past 4 weeks from screening.
4. Subjects requiring oxygen therapy (at least 12 hours daily) in past 4 weeks from screening.
5. Clinically significant ECG abnormality.
6. Clinically significant neurologic, cardiovascular, hepatic, renal, endocrine, pulmonary (post-tuberculosis fibrosis, pulmonary fibrotic disease, pulmonary arterial hypertension), hematologic, psychiatric or other medical illness that will interfere with participation in this study.
7. History of asthma (rule out complete history and examination of asthma and/or post-bronchodilator FEV1 values greater than 400ml of predicted normal values) with persistent airflow limitation or history of atopy or any other chronic respiratory disease other than COPD.
8. Subjects on dual bronchodialator such as LABA/LAMA or SABA/SAMA or on tripe therapy for COPD within 3 months from screening.
9. Life-threatening/unstable respiratory disease, including lower respiratory tract infection, within past 4 weeks from screening.
10. History of lung resection of more than one full lobe.
11. Scheduled for in-patient hospitalization, including elective surgery during the trial.
12. Clinically significant laboratory values, as judged by the investigator.
13. History of clinically significant bladder neck obstruction or urinary retention.
14. History of glaucoma.
15. History of diabetes mellitus.
16. Participation in clinical trial in within past 4 weeks of screening.
17. Female who is pregnant or lactating or planning to be pregnant.
18. Woman of childbearing potential who is unwilling to use adequate contraceptive measures unless abstinence is considered adequate in the opinion of the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method