Clinical trial NCT01072448: 12-week Efficacy of Indacaterol
Official title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Once Daily Indacaterol in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
indacaterol
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-02-22
Enrollment: 323
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 12-week study evaluated the efficacy and safety of indacaterol versus placebo.


Eligibility criteria: Inclusion criteria:

* Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2008) and:

  * Smoking history of at least 10 pack-years
  * Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
  * 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 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 co-morbid conditions 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: Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)
timeFrame: End of the study (Week 12, Day 84)
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Novartis Investigator Site
state: Arizona
city: Pine Bluff
country: United States
facility: Novartis Investigator Site
state: Arkansas
city: Buena Park
country: United States
facility: Novartis Investigator Site
state: California
city: Encinitas
country: United States
facility: Novartis Investigator Site
state: California
city: Fountain Valley
country: United States
facility: Novartis Investigator Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigator Site
state: California
city: San Diego
country: United States
facility: Novartis Investigator Site
state: California
city: San Diego
country: United States
facility: Novartis Investigator Site
state: California
city: Temecula
country: United States
facility: Novartis Investigator Site
state: California
city: Torrance
country: United States
facility: Novartis Investigator Site
state: California
city: Walnut Creek
country: United States
facility: Novartis Investigator Site
state: California
city: Wheat Ridge
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Port Orange
country: United States
facility: Novartis Investigative Site
state: Florida
city: Sarasota
country: United States
facility: Novartis Investigative Site
state: Florida
city: Tamarac
country: United States
facility: Novartis Investigative Site
state: Florida
city: Couer D'Alene
country: United States
facility: Novartis Investigator Site
state: Idaho
city: Champaign
country: United States
facility: Novartis Investigator Site
state: Illinois
city: Downers Grove
country: United States
facility: Novartis Investigator Site
state: Illinois
city: River Forest
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Skokie
country: United States
facility: Novartis Investigator Site
state: Illinois
city: Springfield
country: United States
facility: Novartis Investigator Site
state: Illinois
city: Lexington
country: United States
facility: Novartis Investigative site
state: Kentucky
city: Covington
country: United States
facility: Novartis Investigator Site
state: Louisiana
city: Metaire
country: United States
facility: Novartis Investigator Site
state: Louisiana
city: Bangor
country: United States
facility: Novartis Investigative Site
state: Maine
city: Columbia
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Clarkston
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Flint
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Livonia
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Edina
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Plymouth
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Florissant
country: United States
facility: Novartis Investigator Site
state: Missouri
city: Ozark
country: United States
facility: Novartis Investigator Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigator Site
state: Missouri
city: Missoula
country: United States
facility: Novartis Investigative Site
state: Montana
city: Bellevue
country: United States
facility: Novartis Investigator Site
state: Nebraska
city: Lincoln
country: United States
facility: Novartis Investigator Site
state: Nebraska
city: Omaha
country: United States
facility: Novartis Investigator Site
state: Nebraska
city: Henderson
country: United States
facility: Novartis Investigator Site
state: Nevada
city: Pahrump
country: United States
facility: Novartis Investigator Site
state: Nevada
city: New Brunswick
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Ocean
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Rochester
country: United States
facility: Novartis Investigative Site
state: New York
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Salisbury
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Medford
country: United States
facility: Novartis Investigator Site
state: Oregon
city: Beaver
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Erie
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Gaffney
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Greer
country: United States
facility: Novartis Investigative site
state: South Carolina
city: Seneca
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Johnson City
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Corsicana
country: United States
facility: Novartis Investigator Site
state: Texas
city: Fort Worth
country: United States
facility: Novartis Investigator Site
state: Texas
city: Salt Lake City
country: United States
facility: Novartis Investigator Site
state: Utah
city: Abingdon
country: United States
facility: Novartis Investigator Site
state: Virginia
city: Newport News
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Tacoma
country: United States
facility: Novartis Investigator Site
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.