NCT02123199CompletedNot Applicable
Prospective Observational Study of the Impact of Indacaterol (Onbrez®) on the Individual Lives and Health Status of Patients With COPD
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- 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
Study Sites (1)
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