Clinical trial NCT00624286: Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
COPD
indacaterol
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-27
Enrollment: 416
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)
timeFrame: 24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)
Secondary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2
timeFrame: 24 hours post-dose on Day 2
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Jasper
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Mobile
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Glendale
country: United States
facility: Novartis Investigator Site
state: Arizona
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Pine Bluff
country: United States
facility: Novartis Investigative Site
state: Arkansas
city: Buena Park
country: United States
facility: Novartis Investigative Site
state: California
city: Encinitas
country: United States
facility: Novartis Investigative Site
state: California
city: Fresno
country: United States
facility: Novartis Investigative Site
state: California
city: Fullerton
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Orange
country: United States
facility: Novartis Investigative Site
state: California
city: Palmdale
country: United States
facility: Novartis Investigative Site
state: California
city: Riverside
country: United States
facility: Novartis Investigative Site
state: California
city: San Jose
country: United States
facility: Novartis Investigative Site
state: California
city: San Mateo
country: United States
facility: Novartis Investigative Site
state: California
city: Stockton
country: United States
facility: Novartis Investigative Site
state: California
city: Torrance
country: United States
facility: Novartis Investigative Site
state: California
city: Vista
country: United States
facility: Novartis Investigative Site
state: California
city: Walnut Creek
country: United States
facility: Novartis Investigative Site
state: California
city: Fort Collins
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Golden
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Newark
country: United States
facility: Novartis Investigative Site
state: Delaware
city: Clearwater
country: United States
facility: Novartis Investigative Site
state: Florida
city: Largo
country: United States
facility: Novartis Investigative Site
state: Florida
city: Ocala
country: United States
facility: Novartis Investigative Site
state: Florida
city: Pensacola
country: United States
facility: Novartis Investigative Site
state: Florida
city: Pensacola
country: United States
facility: Novartis Investigative Site
state: Florida
city: Pensacola
country: United States
facility: Novartis Investigative Site
state: Florida
city: Rockledge
country: United States
facility: Novartis Investigative Site
state: Florida
city: Sarasota
country: United States
facility: Novartis Investigator Site
state: Florida
city: South Miami
country: United States
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state: Florida
city: Tamarac
country: United States
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state: Florida
city: Tampa
country: United States
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state: Florida
city: Zephyrhills
country: United States
facility: Novartis Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Austell
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Normal
country: United States
facility: Novartis Investigative Site
state: Illinois
city: O fallon
country: United States
facility: Novartis Investigative Site
state: Illinois
city: River Forest
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Indianapolis
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Ames
country: United States
facility: Novartis Investigative Site
state: Iowa
city: Iowa City
country: United States
facility: Novartis Investigative Site
state: Iowa
city: Shawnee
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Crescent springs
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Lexington
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Madisonville
country: United States
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state: Kentucky
city: Metairie
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Opelousas
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Slidell
country: United States
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state: Louisiana
city: Worcester
country: United States
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state: Massachusetts
city: Ann Arbor
country: United States
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state: Michigan
city: Clarkston
country: United States
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state: Michigan
city: Flint
country: United States
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state: Michigan
city: Livonia
country: United States
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state: Michigan
city: Troy
country: United States
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state: Michigan
city: Edina
country: United States
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state: Minnesota
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Saint Louis
country: United States
facility: Novartis Investigator Site
state: Missouri
city: St Charles
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Kalispell
country: United States
facility: Novartis Investigative Site
state: Montana
city: Missoula
country: United States
facility: Novartis Investigative Site
state: Montana
city: Lincoln
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Henderson
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Cherry Hill
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Summit
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Cortland
country: United States
facility: Novartis Investigative Site
state: New York
city: Rochester
country: United States
facility: Novartis Investigative Site
state: New York
city: Charlotte
country: United States
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state: North Carolina
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: High Point
country: United States
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state: North Carolina
city: Shelby
country: United States
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state: North Carolina
city: Cincinnati
country: United States
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state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Columbus
country: United States
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state: Ohio
city: Columbus
country: United States
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state: Ohio
city: Marion
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facility: Novartis Investigative Site
state: Ohio
city: Thornville
country: United States
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state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Tulsa
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Eugene
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Medford
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Erie
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Homestead
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Cumberland
country: United States
facility: Novartis Investigative Site
state: Rhode Island
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Gaffney
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Greenville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: N. Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Union
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Johnson City
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Amarillo
country: United States
facility: Novartis Investigative Site
state: Texas
city: El Paso
country: United States
facility: Novartis Investigative Site
state: Texas
city: Ft. Worth
country: United States
facility: Novartis Investigative Site
state: Texas
city: New braunfels
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Payson
country: United States
facility: Novartis Investigative Site
state: Utah
city: Abingdon
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Lynchburg
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Spokane Valley
country: United States
facility: Novartis Investigative Site
state: Washington
city: Spokane
country: United States
facility: Novartis Investigative Site
state: Washington
city: Tacoma
country: United States
facility: Novartis Investigative Site
state: Washington
city: Morgantown
country: United States
facility: Novartis Investigative Site
state: West Virginia
city: Milwaukee
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Lanaken
country: Belgium
facility: Novartis Investigative Site
city: Tauranga
country: New Zealand
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.