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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01272362

Acronym

REVERBREZ

Enrollment

625

Registered

2011-01-07

Start date

2010-04-30

Completion date

2012-05-31

Last updated

2016-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Indacaterol, COPD, LABA, Reversibility

Brief summary

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

Interventions

DRUGIndacaterol

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and: 1. Post-bronchodilator FEV1 \<80% and ≥30% of the predicted normal value 2. 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/

Design outcomes

Primary

Measure	Time frame	Description
Coefficient of correlation between FEV1 and reversibility	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

Measure	Time frame	Description
Coefficient of correlation between VQ11 (an assessment of quality of life) and reversibility	5 months	Coefficient of correlation between the change from baseline in VQ11 with indacaterol after 5 months and the reversibility to salbutamol at screening

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026