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To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol (REVERBREZ)

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Novartis

Status and phase

Completed
Phase 4

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: Indacaterol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01272362
CQAB149BFR01
2010-022831-12 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

625 patients

Sex

All

Ages

40+ years old

Volunteers

No 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/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

625 participants in 1 patient group

Indacaterol
Experimental group
Treatment:
Drug: Indacaterol

Trial contacts and locations

137

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Data sourced from clinicaltrials.gov

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