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Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00624286

Last Updated: 2011-08-18

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-07-31

Brief Summary

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This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).

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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 150 μg

Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Group Type EXPERIMENTAL

Indacaterol 150 μg

Intervention Type DRUG

Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Placebo to indacaterol

Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Group Type PLACEBO_COMPARATOR

Placebo to indacaterol

Intervention Type DRUG

Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Interventions

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Indacaterol 150 μg

Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Intervention Type DRUG

Placebo to indacaterol

Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

• Male or female patients aged 40 years or over with moderate to severe chronic obstructive pulmonary disease (COPD) plus

* 20 pack-year smoking history
* Signed informed consent
* Post-bronchodilator forced expiratory volume in 1 second )FEV1) ≥ 30% and \< 80% predicted FEV1/FVC (forced vital capacity) \< 70%

Exclusion Criteria

* History of asthma
* Prior exposure to indacaterol
* Active cancer or history of cancer
* Patients with concomitant pulmonary disease
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged
* Patients unable to successfully use a dry-powder inhaler device or perform spirometry measurements
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

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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Birmingham, Alabama, United States

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Jasper, Alabama, United States

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Mobile, Alabama, United States

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Pine Bluff, Arkansas, United States

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Buena Park, California, United States

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Encinitas, California, United States

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Fresno, California, United States

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Fullerton, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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Palmdale, California, United States

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Riverside, California, United States

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San Jose, California, United States

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San Mateo, California, United States

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Stockton, California, United States

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Torrance, California, United States

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Vista, California, United States

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Walnut Creek, California, United States

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Fort Collins, Colorado, United States

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Golden, Colorado, United States

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Wheat Ridge, Colorado, United States

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Newark, Delaware, United States

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Clearwater, Florida, United States

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Largo, Florida, United States

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Ocala, Florida, United States

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Pensacola, Florida, United States

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Pensacola, Florida, United States

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Pensacola, Florida, United States

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Rockledge, Florida, United States

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Sarasota, Florida, United States

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South Miami, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Zephyrhills, Florida, United States

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Atlanta, Georgia, United States

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Austell, Georgia, United States

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Normal, Illinois, United States

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O'Fallon, Illinois, United States

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River Forest, Illinois, United States

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Indianapolis, Indiana, United States

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Ames, Iowa, United States

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Iowa City, Iowa, United States

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Shawnee, Kansas, United States

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Crescent Springs, Kentucky, United States

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Lexington, Kentucky, United States

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Madisonville, Kentucky, United States

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Metairie, Louisiana, United States

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Opelousas, Louisiana, United States

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Slidell, Louisiana, United States

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Worcester, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Clarkston, Michigan, United States

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Flint, Michigan, United States

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Livonia, Michigan, United States

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Troy, Michigan, United States

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Edina, Minnesota, United States

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Minneapolis, Minnesota, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Kalispell, Montana, United States

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Missoula, Montana, 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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Summit, New Jersey, United States

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Cortland, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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High Point, North Carolina, United States

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Shelby, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, 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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Thornville, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Erie, Pennsylvania, United States

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Homestead, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Cumberland, Rhode Island, United States

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Charleston, South Carolina, United States

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Gaffney, 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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Johnson City, Tennessee, United States

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Amarillo, Texas, United States

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El Paso, Texas, United States

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Fort Worth, Texas, United States

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New Braunfels, Texas, United States

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San Antonio, Texas, United States

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Payson, Utah, United States

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Abingdon, Virginia, United States

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Lynchburg, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Spokane, Washington, United States

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Spokane Valley, Washington, United States

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Tacoma, Washington, United States

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Morgantown, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Lanaken, , Belgium

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Tauranga, , New Zealand

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Countries

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United States Belgium New Zealand

References

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Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011 Dec 29;12(1):161. doi: 10.1186/1465-9921-12-161.

Reference Type DERIVED
PMID: 22206353 (View on PubMed)

Bleecker ER, Siler T, Owen R, Kramer B. Bronchodilator efficacy and safety of indacaterol 150 mug once daily in patients with COPD: an analysis of pooled data. Int J Chron Obstruct Pulmon Dis. 2011;6:431-8. doi: 10.2147/COPD.S21073. Epub 2011 Aug 18.

Reference Type DERIVED
PMID: 22003288 (View on PubMed)

Feldman G, Siler T, Prasad N, Jack D, Piggott S, Owen R, Higgins M, Kramer B; INLIGHT 1 study group. Efficacy and safety of indacaterol 150 microg once-daily in COPD: a double-blind, randomised, 12-week study. BMC Pulm Med. 2010 Mar 8;10:11. doi: 10.1186/1471-2466-10-11.

Reference Type DERIVED
PMID: 20211002 (View on PubMed)

Other Identifiers

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EUDRACT Number: 2008-000301-11

Identifier Type: -

Identifier Source: secondary_id

CQAB149B2346

Identifier Type: -

Identifier Source: org_study_id

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