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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014