Study of the Impact of Indacaterol (Onbrez®) on the Individual Lives and Health Status of Patients With COPD

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Indacaterol (Onbrez®) /QAB149

• Registration Number: NCT02123199
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

A prospective observational multi centre research study in GP practices clustered within up to 10 UK Primary care trusts.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-12
• Status Verified: 2014-04
• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-24
• Last Update Submitted: 2014-04-24
• Study First Posted: 2014-04-25
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Patients with active diagnosis of COPD, confirmed by spirometry documented in medical notes

Exclusion Criteria

• Patients who are currently receiving other maintenance therapy (except LAMA) for COPD.
• Patients previously prescribed Indacaterol.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Indacaterol/QAB149	Indacaterol (Onbrez®) /QAB149	Patients treated with Indacaterol for COPD prior to enrollment in study

Primary Outcome Measures

Name	Time	Method
Change in COPD assessment Test (CAT Score) at 6-8 weeks after the initiation of indacaterol	6-8 weeks

Secondary Outcome Measures

Name	Time	Method
Physician Global Evaluation of Treatment effectiveness (GETE) at 6-8 weeks and 6 months.	6-8 weeks and 6 months
Patient Global Evaluation of Treatment effectiveness (GETE) at 6 months	6 months
Change in COPD Assessment test (CAT) score at 6 months after the initiation of indacaterol	6 months
Impact of indacaterol on patients' lies at 6 - 8 weeks after the initiation of indacaterol.	6-8 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 London, United Kingdom