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Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks

NCT ID: NCT01068600

Last Updated: 2011-08-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

318 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Brief Summary

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This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Indacaterol 75 µg

Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.

Group Type EXPERIMENTAL

Indacaterol

Intervention Type DRUG

Once daily via single-dose dry powder inhaler (SDDPI)

Placebo

Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.

Group Type PLACEBO_COMPARATOR

Placebo to indacaterol

Intervention Type DRUG

Once daily via SDDPI

Interventions

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Indacaterol

Once daily via single-dose dry powder inhaler (SDDPI)

Intervention Type DRUG

Placebo to indacaterol

Once daily via SDDPI

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

1. Smoking history of at least 10 pack-years
2. Post-bronchodilator FEV1 \<80% and ≥30% of the predicted normal value
3. Post-bronchodilator FEV1/FVC (forced vital capacity) \<70%

Exclusion Criteria

* Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization for in the 6 weeks prior to screening
* Patients who have had a respiratory tract infection within 6 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Anniston, Alabama, United States

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Novartis Investigative Site

Jasper, Alabama, United States

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Fullerton, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Riverside, California, United States

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Novartis Investigative Site

Clearwater, Florida, United States

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Clearwater, Florida, United States

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Hollywood, Florida, United States

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Miami, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Normal, Illinois, United States

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Iowa City, Iowa, United States

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Madisonville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Opelousas, Louisiana, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Cherry Hill, New Jersey, United States

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Albuquerque, New Mexico, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Shelby, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Marion, Ohio, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Cumberland, Rhode Island, United States

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Pawtucket, Rhode Island, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Easley, South Carolina, United States

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Greenville, South Carolina, United States

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North Charleston, South Carolina, United States

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Spartanburg, South Carolina, United States

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Union, South Carolina, United States

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Arlington, Texas, United States

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Dickinson, Texas, United States

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El Paso, Texas, United States

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McKinney, Texas, United States

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Novartis Investigative Site

South Burlington, Vermont, United States

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Novartis Investigative Site

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Gotfried MH, Kerwin EM, Lawrence D, Lassen C, Kramer B. Efficacy of indacaterol 75 mug once-daily on dyspnea and health status: results of two double-blind, placebo-controlled 12-week studies. COPD. 2012 Dec;9(6):629-36. doi: 10.3109/15412555.2012.729623. Epub 2012 Sep 28.

Reference Type DERIVED
PMID: 23020650 (View on PubMed)

Kerwin EM, Gotfried MH, Lawrence D, Lassen C, Kramer B. Efficacy and tolerability of indacaterol 75 mug once daily in patients aged >/=40 years with chronic obstructive pulmonary disease: results from 2 double-blind, placebo-controlled 12-week studies. Clin Ther. 2011 Dec;33(12):1974-84. doi: 10.1016/j.clinthera.2011.11.009.

Reference Type DERIVED
PMID: 22177371 (View on PubMed)

Other Identifiers

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CQAB149B2355

Identifier Type: -

Identifier Source: org_study_id

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