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Clinical Trials/NCT02123199
NCT02123199CompletedNot Applicable

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

Novartis Pharmaceuticals1 site in 1 country103 target enrollmentStarted: April 2012Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
103
Locations
1
Primary Endpoint
Change in COPD assessment Test (CAT Score) at 6-8 weeks after the initiation of indacaterol

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Indacaterol/QAB149

Patients treated with Indacaterol for COPD prior to enrollment in study

Intervention: Indacaterol (Onbrez®) /QAB149 (Drug)

Outcomes

Primary Outcomes

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

Time Frame: 6-8 weeks

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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