A prospective, observational study to evaluate effectiveness and safety of fixed dose combination of Indacaterol maleate 110 mcg and Glycopyrronium bromide 50 mcg in stable Chronic Obstructive Pulmonary Disease (COPD) patients

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: CTRI/2016/11/007460
• Lead Sponsor: Novartis Healthcare private limited

Brief Summary

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This is an open-label, multicenter, prospective, observational study to evaluate, effectiveness and safety of FDC of Indacaterol maleate 110 mcg + Glycopyrronium bromide 50 mcg prescribed in patients of COPD as per discretion of treating physician. The prescription decision shall be independent of decision for inclusion in the study. Patients treated according to local routine clinical practice will be enrolled in the study upon signing an Informed Consent. Eligibility for study entry will be determined by the study investigator, in accordance with the selection criteria below. Signing of the Informed Consent defines the study entry visit.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-14
• Last Update Posted: 2018-10-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 428

Inclusion Criteria

• COPD patients prescribed with FDC of Indacaterol maleate 110 mcg + Glycopyrronium bromide 50 mcg as per discretion of treating physician and as per product prescribing information.
• Patients willing to participate in the study by providing written informed consent.

Exclusion Criteria

• Contraindication as per PI 2.
• Patients simultaneously participating in other studies or use of other investigational drug at the time of enrollment or 5 times the half life of the investigational product prior to visit 1.
• Pregnant women should not be included except if, in the opinion of the investigator, the expected benefit outweighs the potential risk to the fetus (please see Section 11 for further information).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To obtain effectiveness data in patients treated with FDC of Indacaterol maleate 110 mcg + Glycopyrronium bromide 50 mcg in terms of trough FEV1 following 26 weeks of treatment in patients with COPD.	26 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Mean change in trough pre-dose FEV1 from baseline to week 8, 16 and 26	26 weeks of treatment
Assessing Safety	26 weeks of treatment
Rate of exacerbation to gain real world experience	26 weeks of treatment

Trial Locations

Locations (32)

Aware Global Hospitals; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

All India Institute of Medical Science; 🇮🇳 Delhi, DELHI, India

Apollo Gleneagles Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Apollo Hospitals; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Apollo Hospitals Enterprise Limited; 🇮🇳 Gandhinagar, GUJARAT, India

Artemis Hospital; 🇮🇳 Gurgaon, HARYANA, India

B.L.K Super Speciality Hospital; 🇮🇳 Delhi, DELHI, India

BGS Global Hospitals; 🇮🇳 Bangalore, KARNATAKA, India

Columbia Asia Hospital-Hebbal; 🇮🇳 Bangalore, KARNATAKA, India

Eesha Hopsital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

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Aware Global Hospitals

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr Sudhir Prasad

Principal investigator

914024111111

drsudhirprasad@gmail.com