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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01272362
Recruitment Status : Completed
First Posted : January 7, 2011
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Indacaterol Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 625 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2010
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: Indacaterol Drug: Indacaterol
Indacaterol 150 µg once-daily via single-dose dry powder inhaler


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272362


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01272362     History of Changes
Other Study ID Numbers: CQAB149BFR01
2010-022831-12 ( EudraCT Number )
First Posted: January 7, 2011    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Indacaterol
COPD
LABA
Reversibility

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