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

April 24, 2014 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited only after indacaterol has been prescribed and is being used for the patients first maintenance therapy for COPD symptoms.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Indacaterol/QAB149
Patients treated with Indacaterol for COPD prior to enrollment in study
Drug: Indacaterol (Onbrez®) /QAB149

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in COPD assessment Test (CAT Score) at 6-8 weeks after the initiation of indacaterol
Time Frame: 6-8 weeks
6-8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 22, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (Estimate)

April 25, 2014

Study Record Updates

Last Update Posted (Estimate)

April 25, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAB149BGB01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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