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

NCT00624286 | Completed Phase 3 Results

• 2 other identifiers: CQAB149B2346EUDRACT Number: 2008-000301-11
• Study Type: interventional
• Target: 416
• Locations: 3 countries
• Sites: 120

Brief Summary

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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease; COPD; indacaterol

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)

  FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

  24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)

Secondary Outcomes (1)

• Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2

  24 hours post-dose on Day 2

Study Arms (2)

Indacaterol 150 μg

EXPERIMENTAL

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.

Drug: Indacaterol 150 μg

Placebo to indacaterol

PLACEBO COMPARATOR

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.

Drug: Placebo to indacaterol

Interventions

Indacaterol 150 μg DRUG

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

Indacaterol 150 μg

Placebo to indacaterol DRUG

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

Placebo to indacaterol

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (120)

Novartis Investigative Site

Anniston, Alabama, 36207-5710, United States

Location

Novartis Investigative Site

Birmingham, Alabama, 35209-6870, United States

Location

Novartis Investigative Site

Jasper, Alabama, 35501, United States

Location

Novartis Investigative Site

Mobile, Alabama, 36608-6705, United States

Location

Novartis Investigator Site

Glendale, Arizona, 85306, United States

Location

Novartis Investigative Site

Phoenix, Arizona, 85006-2611, United States

Location

Novartis Investigative Site

Phoenix, Arizona, 85013-4232, United States

Location

Novartis Investigative Site

Tucson, Arizona, 85712, United States

Location

Novartis Investigative Site

Tucson, Arizona, 85723, United States

Location

Novartis Investigative Site

Pine Bluff, Arkansas, 71603, United States

Location

Novartis Investigative Site

Buena Park, California, 90620, United States

Location

Novartis Investigative Site

Encinitas, California, 92024-1332, United States

Location

Novartis Investigative Site

Fresno, California, 93710, United States

Location

Novartis Investigative Site

Fullerton, California, 92835, United States

Location

Novartis Investigative Site

Los Angeles, California, 90048, United States

Location

Novartis Investigative Site

Orange, California, 92869, United States

Location

Novartis Investigative Site

Palmdale, California, 93551-1411, United States

Location

Novartis Investigative Site

Riverside, California, 92506, United States

Location

Novartis Investigative Site

San Jose, California, 95117, United States

Location

Novartis Investigative Site

San Mateo, California, 94401, United States

Location

Novartis Investigative Site

Stockton, California, 95207, United States

Location

Novartis Investigative Site

Torrance, California, 90503, United States

Location

Novartis Investigative Site

Vista, California, 92083, United States

Location

Novartis Investigative Site

Walnut Creek, California, 94598, United States

Location

Novartis Investigative Site

Fort Collins, Colorado, 80528-3400, United States

Location

Novartis Investigative Site

Golden, Colorado, 80401, United States

Location

Novartis Investigator Site

Wheat Ridge, Colorado, 80033-4300, United States

Location

Novartis Investigative Site

Newark, Delaware, 19713, United States

Location

Novartis Investigative Site

Clearwater, Florida, 33765, United States

Location

Novartis Investigative Site

Largo, Florida, 33770-2335, United States

Location

Novartis Investigative Site

Ocala, Florida, 34471, United States

Location

Novartis Investigative Site

Pensacola, Florida, 32503, United States

Location

Novartis Investigative Site

Pensacola, Florida, 32504-8756, United States

Location

Novartis Investigative Site

Pensacola, Florida, 32504, United States

Location

Novartis Investigative Site

Rockledge, Florida, 32955, United States

Location

Novartis Investigator Site

Sarasota, Florida, 34233-1272, United States

Location

Novartis Investigative Site

South Miami, Florida, 33143, United States

Location

Novartis Investigative Site

Tamarac, Florida, 33321, United States

Location

Novartis Investigative Site

Tampa, Florida, 33603, United States

Location

Novartis Investigative Site

Zephyrhills, Florida, 33542-7505, United States

Location

Novartis Investigative Site

Atlanta, Georgia, 30342, United States

Location

Novartis Investigative Site

Austell, Georgia, 30106-1110, United States

Location

Novartis Investigative Site

Normal, Illinois, 61761, United States

Location

Novartis Investigative Site

O'Fallon, Illinois, 62269, United States

Location

Novartis Investigative Site

River Forest, Illinois, 60305, United States

Location

Novartis Investigative Site

Indianapolis, Indiana, 46285, United States

Location

Novartis Investigative Site

Ames, Iowa, 50010, United States

Location

Novartis Investigative Site

Iowa City, Iowa, 52240, United States

Location

Novartis Investigative Site

Shawnee, Kansas, 66216-1800, United States

Location

Novartis Investigative Site

Crescent Springs, Kentucky, 41017, United States

Location

Novartis Investigative Site

Lexington, Kentucky, 40504, United States

Location

Novartis Investigative Site

Madisonville, Kentucky, 42431, United States

Location

Novartis Investigative Site

Metairie, Louisiana, 70006-4225, United States

Location

Novartis Investigative Site

Opelousas, Louisiana, 70570, United States

Location

Novartis Investigative Site

Slidell, Louisiana, 70458, United States

Location

Novartis Investigative Site

Worcester, Massachusetts, 01605, United States

Location

Novartis Investigative Site

Ann Arbor, Michigan, 48105-9755, United States

Location

Novartis Investigative Site

Clarkston, Michigan, 48346, United States

Location

Novartis Investigative Site

Flint, Michigan, 58532, United States

Location

Novartis Investigative Site

Livonia, Michigan, 48152, United States

Location

Novartis Investigative Site

Troy, Michigan, 48085, United States

Location

Novartis Investigator Site

Edina, Minnesota, 55435, United States

Location

Novartis Investigative Site

Minneapolis, Minnesota, 55407, United States

Location

Novartis Investigative Site

Saint Charles, Missouri, 63301-2847, United States

Location

Novartis Investigator Site

St Louis, Missouri, 63141, United States

Location

Novartis Investigative Site

Kalispell, Montana, 59901, United States

Location

Novartis Investigative Site

Missoula, Montana, 59808, United States

Location

Novartis Investigative Site

Lincoln, Nebraska, 68510, United States

Location

Novartis Investigative Site

Omaha, Nebraska, 68114-3570, United States

Location

Novartis Investigative Site

Omaha, Nebraska, 68134, United States

Location

Novartis Investigative Site

Henderson, Nevada, 89014, United States

Location

Novartis Investigative Site

Las Vegas, Nevada, 89102-4508, United States

Location

Novartis Investigative Site

Cherry Hill, New Jersey, 08003, United States

Location

Novartis Investigative Site

Summit, New Jersey, 07901, United States

Location

Novartis Investigative Site

Cortland, New York, 13045, United States

Location

Novartis Investigative Site

Rochester, New York, 14618, United States

Location

Novartis Investigative Site

Charlotte, North Carolina, 28207, United States

Location

Novartis Investigative Site

Charlotte, North Carolina, 28277, United States

Location

Novartis Investigative Site

High Point, North Carolina, 27262-4320, United States

Location

Novartis Investigative Site

Shelby, North Carolina, 28150, United States

Location

Novartis Investigative Site

Cincinnati, Ohio, 45227, United States

Location

Novartis Investigative Site

Cincinnati, Ohio, 45231, United States

Location

Novartis Investigator Site

Cincinnati, Ohio, 45242, United States

Location

Novartis Investigative Site

Columbus, Ohio, 43213, United States

Location

Novartis Investigative Site

Columbus, Ohio, 43215, United States

Location

Novartis Investigative Site

Marion, Ohio, 43302, United States

Location

Novartis Investigative Site

Thornville, Ohio, 43076-8010, United States

Location

Novartis Investigative Site

Oklahoma City, Oklahoma, 73112, United States

Location

Novartis Investigative Site

Tulsa, Oklahoma, 74135-2920, United States

Location

Novartis Investigative Site

Eugene, Oregon, 97404, United States

Location

Novartis Investigative Site

Medford, Oregon, 97504-9741, United States

Location

Novartis Investigative Site

Portland, Oregon, 97213, United States

Location

Novartis Investigative Site

Erie, Pennsylvania, 15608, United States

Location

Novartis Investigative Site

Homestead, Pennsylvania, 15120, United States

Location

Novartis Investigative Site

Pittsburgh, Pennsylvania, 15243-1800, United States

Location

Novartis Investigative Site

Cumberland, Rhode Island, 02864, United States

Location

Novartis Investigative Site

Charleston, South Carolina, 29412, United States

Location

Novartis Investigative Site

Gaffney, South Carolina, 29340, United States

Location

Novartis Investigative Site

Greenville, South Carolina, 29615, United States

Location

Novartis Investigative Site

North Charleston, South Carolina, 29406-9167, United States

Location

Novartis Investigative Site

Spartanburg, South Carolina, 29303, United States

Location

Novartis Investigative Site

Union, South Carolina, 29379, United States

Location

Novartis Investigative Site

Johnson City, Tennessee, 37601, United States

Location

Novartis Investigative Site

Amarillo, Texas, 79106, United States

Location

Novartis Investigative Site

El Paso, Texas, 79902-5107, United States

Location

Novartis Investigative Site

Fort Worth, Texas, 76104-4185, United States

Location

Novartis Investigative Site

New Braunfels, Texas, 78130-6113, United States

Location

Novartis Investigative Site

San Antonio, Texas, 78229, United States

Location

Novartis Investigative Site

Payson, Utah, 84651, United States

Location

Novartis Investigative Site

Abingdon, Virginia, 24210-2921, United States

Location

Novartis Investigative Site

Lynchburg, Virginia, 24501, United States

Location

Novartis Investigative Site

Richmond, Virginia, 23229, United States

Location

Novartis Investigative Site

Richmond, Virginia, 23298, United States

Location

Novartis Investigative Site

Spokane, Washington, 99201, United States

Location

Novartis Investigative Site

Spokane Valley, Washington, 99216-1092, United States

Location

Novartis Investigative Site

Tacoma, Washington, 98405, United States

Location

Novartis Investigative Site

Morgantown, West Virginia, 26505-2713, United States

Location

Novartis Investigative Site

Milwaukee, Wisconsin, 53209, United States

Location

Novartis Investigative Site

Lanaken, Belgium

Location

Novartis Investigator Site

Tauranga, New Zealand

Location

Related Publications (3)

• 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.

  PMID: 22206353 DERIVED

• 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.

  PMID: 22003288 DERIVED

• 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.

  PMID: 20211002 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 15, 2008
• First Posted: February 27, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 18, 2011
• Results First Posted: August 18, 2011

Record last verified: 2011-07

Locations

BE (1); US (118); NZ (1)