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

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 - Ultibro Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/11/007460

Enrollment

428

Registered

2016-11-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic Obstructive Pulmonary Disease

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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. 2. Patients willing to participate in the study by providing written informed consent.

Exclusion criteria

Exclusion criteria: 1. 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).

Design outcomes

Secondary

Measure	Time frame
Assessing SafetyTimepoint: 26 weeks of treatment;Mean change in trough pre-dose FEV1 from baseline to week 8, 16 and 26Timepoint: 26 weeks of treatment;Rate of exacerbation to gain real world experienceTimepoint: 26 weeks of treatment	—

Primary

Measure	Time frame
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.Timepoint: 26 weeks of treatment	—

Countries

India

Contacts

Public ContactDr Pallavi Kawatra

Novartis Healthcare Pvt Ltd

pallavi.kawatra@novartis.com50243596

Outcome results