A 12-week study to determine efficacy and safety of Glycopyrronium Formoterol combination through dry powder inhaler in patients with Chronic Obstructive Pulmonary Disease

Phase 3

Completed

• Conditions: Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: CTRI/2017/08/009286
• Lead Sponsor: Cipla Ltd

Brief Summary

This is randomized, prospective, open label, comparative, parallelgroup, multicentre, phase III study to evaluate efficacy, safety andtolerability of Glycopyrronium/Formoterol FDC 25mcg/12mcg twice daily comparedwith Glycopyrronium 50mcg once daily. 360 subjects of moderate to severe COPDwill be randomized considering 30% dropout and will be receive eitherGlycopyrronium/Formoterol FDC or Glycopyrronium treatment for 12 weeks.

Primary outcome is Mean change in pre-dose trough FEV1at 12 weeks of treatment from baseline.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-08
• Study Completion: 2018-10-30
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• A voluntarily given, written, signed, and dated Informed Consent from subject and/or legally acceptable representative.
• Subjects of either gender and age between 40 and 65 years (both inclusive) 3.
• Subjects with moderate to severe COPD (GOLD 2015).
• Subjects should have a documented history of COPD and spirogram within at least the past 6 months 4.
• Post-bronchodilator FEV1 ≥ 40% and ≤ 80% of the predicted normal value 5.
• Post bronchodilator FEV1/FVC ratio of <0.7 6.
• Subjects having ability to use pMDI and DPI during the course of the study and able to comply with the study protocol.

Exclusion Criteria

• 1.Hypersensitivity to Glycopyrronium or Formoterol or Levosalbutamol or Budesonide or Ipratropium or any of its components 2.
• Subjects with any hospitalization required for exacerbation or any serious condition in the previous 12 weeks 3.
• Subjects who had more than two exacerbations in past 1 year 4.
• Subjects requiring oxygen therapy 6.
• Clinically significant ECG abnormality 7.
• Absolute Blood eosinophil count >600 cells/c mm of blood.
• 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 9.
• History of asthma or any chronic respiratory disease other than COPD.
• Life-threatening/unstable respiratory disease, including lower respiratory tract infection, within the previous 4 weeks.
• History of lung resection of more than one full lobe.
• Scheduled for in-patient hospitalization, including elective surgery during the trial.
• Clinically significant laboratory values, as judged by the investigator.
• History of clinically significant bladder neck obstruction or urinary retention 16.
• History of uncontrolled diabetes mellitus 18.
• Subjects receiving immunotherapy or live vaccine within past 1 year and inactivated vaccine within 1 month from screening visit 1 19.
• Participation in clinical trial in prior 4 weeks of screening visit 1.
• Participation in clinical trial of Glycopyrronium alone or in combination within past 3 months of screening visit 1 21.
• Female who is pregnant or lactating or planning to be pregnant.
• 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
Mean change in pre dose trough FEV1	At 12 weeks of treatment from baseline

Secondary Outcome Measures

Name	Time	Method
Mean change in 1 hour post dose FEV1 and FVC	At 2, 4, 8 and 12 weeks of treatment from baseline
Mean change in pre dose trough FVC	At 2, 4, 8 and 12 weeks of treatment from baseline
Mean change in pre dose trough FEV1	At 2, 4, and 8 weeks of treatment from baseline
Difference in average daily number of pMDI puffs of rescue medication consumed	At 2, 4, 8 and 12 weeks of treatment from baseline
Mean change in mMRC scale	At 4, 8 and 12 weeks of treatment from baseline
Mean change in CAT score	At 4, 8 and 12 weeks of treatment from baseline
Mean change in COPD and Asthma Sleep Impact Scale (CASIS) score	At 4, 8 and 12 weeks of treatment from baseline

Trial Locations

Locations (33)

AMAI Charitable Trust’s Ace Hospital and Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Apex Hospital Private Limited; 🇮🇳 Jaipur, RAJASTHAN, India

Ashirwad Hospital & Research Center; 🇮🇳 Thane, MAHARASHTRA, India

Asian Institute of Medical Sciences; 🇮🇳 Thane, MAHARASHTRA, India

Asthma Bhawan; 🇮🇳 Jaipur, RAJASTHAN, India

Bansal Hospital and Research Center; 🇮🇳 Jaipur, RAJASTHAN, India

Chest Research Foundation; 🇮🇳 Pune, MAHARASHTRA, India

Department of Pulmonary Medicine, Govt. Siddhartha Medical college; 🇮🇳 Krishna, ANDHRA PRADESH, India

Dr Hedgewar Hospital; 🇮🇳 Aurangabad, MAHARASHTRA, India

Dr. Murarilal Chest Hospital; 🇮🇳 Nagar, UTTAR PRADESH, India

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AMAI Charitable Trust’s Ace Hospital and Research Centre

🇮🇳Pune, MAHARASHTRA, India

Dr Pophale Himanshu Shashikant

Principal investigator

9503939461

himanshupophale@yahoo.co.in