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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01272362
First received: January 5, 2011
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
 Drug: Indacaterol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Drug Information available for: Indacaterol
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Coefficient of correlation between FEV1 and reversibility [ Time Frame: After 1 month ] [ Designated as safety issue: No ]
    Coefficient of correlation between the change from baseline in FEV1 with indacaterol after 1 month and the reversibility to salbutamol at screening


Secondary Outcome Measures:
  • Coefficient of correlation between VQ11 (an assessment of quality of life) and reversibility [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Coefficient of correlation between the change from baseline in VQ11 with indacaterol after 5 months and the reversibility to salbutamol at screening


Enrollment: 625
Study Start Date: April 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indacaterol Drug: Indacaterol
Indacaterol 150 µg once-daily via single-dose dry powder inhaler

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272362

  Show 137 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01272362     History of Changes
Other Study ID Numbers: CQAB149BFR01, 2010-022831-12
Study First Received: January 5, 2011
Last Updated: November 29, 2012
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Novartis:
Indacaterol
COPD
LABA
Reversibility

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013