To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol

In this 5-months study, the response of patients to salbutamol at baseline will be compared with their response to treatment with indacaterol.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Ferolles-Attily, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and:

Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
Post-bronchodilator FEV1/FVC (forced vital capacity) <70%
Smoking history of at least 10 pack-years

Exclusion criteria

Patients who have had a COPD exacerbation in the 6 weeks prior to screening
Patients who have had a respiratory tract infection within 4 weeks prior to screening
Patients with concomitant pulmonary disease
Patients with a history of asthma
Patients with diabetes Type I or uncontrolled diabetes Type II
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Indacaterol

Drug

Indacaterol 150 µg once-daily via single-dose dry powder inhaler

Primary outcomes

Coefficient of correlation between FEV1 and reversibility

Time frame: After 1 month

Coefficient of correlation between the change from baseline in FEV1 with indacaterol after 1 month and the reversibility to salbutamol at screening

Secondary outcomes

Coefficient of correlation between VQ11 (an assessment of quality of life) and reversibility

Time frame: 5 months

Coefficient of correlation between the change from baseline in VQ11 with indacaterol after 5 months and the reversibility to salbutamol at screening

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Study of the Predictive Value of Airway Obstruction Reversibility on the Effectiveness of Indacaterol (Onbrez® Breezhaler ®) 150 mcg Once Daily in Patients With Moderate to Severe COPD

Acronym: REVERBREZ

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Jan 7, 2011
Registry last updated: Nov 16, 2016

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.

Published trials that share one or more normalized conditions with this study.

Completed