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OpenTrials
Completed

NCT Number: NCT02123199

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.

Completed

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indacaterol (Onbrez®) /QAB149

Drug

Primary outcomes

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

    Time frame: 6-8 weeks

Secondary outcomes

  1. Change in COPD Assessment test (CAT) score at 6 months after the initiation of indacaterol

    Time frame: 6 months

  2. Impact of indacaterol on patients' lies at 6 - 8 weeks after the initiation of indacaterol.

    Time frame: 6-8 weeks

  3. Physician Global Evaluation of Treatment effectiveness (GETE) at 6-8 weeks and 6 months.

    Time frame: 6-8 weeks and 6 months

  4. Patient Global Evaluation of Treatment effectiveness (GETE) at 6 months

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: INHALE

Important dates

Study start
2012
Primary completion
2013
First posted
Apr 25, 2014
Registry last updated
Apr 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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