Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Indacaterol (150 μg o.d.) in Patients With Chronic Obstructive Pulmonary Disease
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).
Status | Completed |
Enrollment | 416 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 include: - 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 Other protocol-defined inclusion/exclusion criteria applied to the study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Novartis Investigative Site | Lanaken | |
New Zealand | Novartis Investigator Site | Tauranga | |
United States | Novartis Investigative Site | Abingdon | Virginia |
United States | Novartis Investigative Site | Amarillo | Texas |
United States | Novartis Investigative Site | Ames | Iowa |
United States | Novartis Investigative Site | Ann Arbor | Michigan |
United States | Novartis Investigative Site | Anniston | Alabama |
United States | Novartis Investigative Site | Atlanta | Georgia |
United States | Novartis Investigative Site | Austell | Georgia |
United States | Novartis Investigative Site | Birmingham | Alabama |
United States | Novartis Investigative Site | Buena Park | California |
United States | Novartis Investigative Site | Charleston | South Carolina |
United States | Novartis Investigative Site | Charlotte | North Carolina |
United States | Novartis Investigative Site | Charlotte | North Carolina |
United States | Novartis Investigative Site | Cherry Hill | New Jersey |
United States | Novartis Investigative Site | Cincinnati | Ohio |
United States | Novartis Investigative Site | Cincinnati | Ohio |
United States | Novartis Investigator Site | Cincinnati | Ohio |
United States | Novartis Investigative Site | Clarkston | Michigan |
United States | Novartis Investigative Site | Clearwater | Florida |
United States | Novartis Investigative Site | Columbus | Ohio |
United States | Novartis Investigative Site | Columbus | Ohio |
United States | Novartis Investigative Site | Cortland | New York |
United States | Novartis Investigative Site | Crescent springs | Kentucky |
United States | Novartis Investigative Site | Cumberland | Rhode Island |
United States | Novartis Investigator Site | Edina | Minnesota |
United States | Novartis Investigative Site | El Paso | Texas |
United States | Novartis Investigative Site | Encinitas | California |
United States | Novartis Investigative Site | Erie | Pennsylvania |
United States | Novartis Investigative Site | Eugene | Oregon |
United States | Novartis Investigative Site | Flint | Michigan |
United States | Novartis Investigative Site | Fort Collins | Colorado |
United States | Novartis Investigative Site | Fresno | California |
United States | Novartis Investigative Site | Ft. Worth | Texas |
United States | Novartis Investigative Site | Fullerton | California |
United States | Novartis Investigative Site | Gaffney | South Carolina |
United States | Novartis Investigator Site | Glendale | Arizona |
United States | Novartis Investigative Site | Golden | Colorado |
United States | Novartis Investigative Site | Greenville | South Carolina |
United States | Novartis Investigative Site | Henderson | Nevada |
United States | Novartis Investigative Site | High Point | North Carolina |
United States | Novartis Investigative Site | Homestead | Pennsylvania |
United States | Novartis Investigative Site | Indianapolis | Indiana |
United States | Novartis Investigative Site | Iowa City | Iowa |
United States | Novartis Investigative Site | Jasper | Alabama |
United States | Novartis Investigative Site | Johnson City | Tennessee |
United States | Novartis Investigative Site | Kalispell | Montana |
United States | Novartis Investigative Site | Largo | Florida |
United States | Novartis Investigative Site | Las Vegas | Nevada |
United States | Novartis Investigative Site | Lexington | Kentucky |
United States | Novartis Investigative Site | Lincoln | Nebraska |
United States | Novartis Investigative Site | Livonia | Michigan |
United States | Novartis Investigative Site | Los Angeles | California |
United States | Novartis Investigative Site | Lynchburg | Virginia |
United States | Novartis Investigative Site | Madisonville | Kentucky |
United States | Novartis Investigative Site | Marion | Ohio |
United States | Novartis Investigative Site | Medford | Oregon |
United States | Novartis Investigative Site | Metairie | Louisiana |
United States | Novartis Investigative Site | Milwaukee | Wisconsin |
United States | Novartis Investigative Site | Minneapolis | Minnesota |
United States | Novartis Investigative Site | Missoula | Montana |
United States | Novartis Investigative Site | Mobile | Alabama |
United States | Novartis Investigative Site | Morgantown | West Virginia |
United States | Novartis Investigative Site | N. Charleston | South Carolina |
United States | Novartis Investigative Site | New braunfels | Texas |
United States | Novartis Investigative Site | Newark | Delaware |
United States | Novartis Investigative Site | Normal | Illinois |
United States | Novartis Investigative Site | O fallon | Illinois |
United States | Novartis Investigative Site | Ocala | Florida |
United States | Novartis Investigative Site | Oklahoma City | Oklahoma |
United States | Novartis Investigative Site | Omaha | Nebraska |
United States | Novartis Investigative Site | Omaha | Nebraska |
United States | Novartis Investigative Site | Opelousas | Louisiana |
United States | Novartis Investigative Site | Orange | California |
United States | Novartis Investigative Site | Palmdale | California |
United States | Novartis Investigative Site | Payson | Utah |
United States | Novartis Investigative Site | Pensacola | Florida |
United States | Novartis Investigative Site | Pensacola | Florida |
United States | Novartis Investigative Site | Pensacola | Florida |
United States | Novartis Investigative Site | Phoenix | Arizona |
United States | Novartis Investigative Site | Phoenix | Arizona |
United States | Novartis Investigative Site | Pine Bluff | Arkansas |
United States | Novartis Investigative Site | Pittsburgh | Pennsylvania |
United States | Novartis Investigative Site | Portland | Oregon |
United States | Novartis Investigative Site | Richmond | Virginia |
United States | Novartis Investigative Site | Richmond | Virginia |
United States | Novartis Investigative Site | River Forest | Illinois |
United States | Novartis Investigative Site | Riverside | California |
United States | Novartis Investigative Site | Rochester | New York |
United States | Novartis Investigative Site | Rockledge | Florida |
United States | Novartis Investigator Site | Saint Louis | Missouri |
United States | Novartis Investigative Site | San Antonio | Texas |
United States | Novartis Investigative Site | San Jose | California |
United States | Novartis Investigative Site | San Mateo | California |
United States | Novartis Investigator Site | Sarasota | Florida |
United States | Novartis Investigative Site | Shawnee | Kansas |
United States | Novartis Investigative Site | Shelby | North Carolina |
United States | Novartis Investigative Site | Slidell | Louisiana |
United States | Novartis Investigative Site | South Miami | Florida |
United States | Novartis Investigative Site | Spartanburg | South Carolina |
United States | Novartis Investigative Site | Spokane | Washington |
United States | Novartis Investigative Site | Spokane Valley | Washington |
United States | Novartis Investigative Site | St Charles | Missouri |
United States | Novartis Investigative Site | Stockton | California |
United States | Novartis Investigative Site | Summit | New Jersey |
United States | Novartis Investigative Site | Tacoma | Washington |
United States | Novartis Investigative Site | Tamarac | Florida |
United States | Novartis Investigative Site | Tampa | Florida |
United States | Novartis Investigative Site | Thornville | Ohio |
United States | Novartis Investigative Site | Torrance | California |
United States | Novartis Investigative Site | Troy | Michigan |
United States | Novartis Investigative Site | Tucson | Arizona |
United States | Novartis Investigative Site | Tucson | Arizona |
United States | Novartis Investigative Site | Tulsa | Oklahoma |
United States | Novartis Investigative Site | Union | South Carolina |
United States | Novartis Investigative Site | Vista | California |
United States | Novartis Investigative Site | Walnut Creek | California |
United States | Novartis Investigator Site | Wheat Ridge | Colorado |
United States | Novartis Investigative Site | Worcester | Massachusetts |
United States | Novartis Investigative Site | Zephyrhills | Florida |
Lead Sponsor | Collaborator |
---|---|
Novartis |
United States, Belgium, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2 | 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 on Day 2 | No |
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