Clinical trial NCT01089127: Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Different Doses of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease, Using Salmeterol as an Active Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Indacaterol
COPD
salmeterol
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-03-18
Enrollment: 552
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 compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol.


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:

  1. Smoking history of at least 10 pack-years
  2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
  3. 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 comorbid 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 2 + 1 Day, Day 15)
timeFrame: 24 hours post-dose at the end of the study (Week 2 + 1 day, Day 15)
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: Florence
country: United States
facility: Novartis Investigator Site
state: Alabama
city: Jasper
country: United States
facility: Novartis Investigator Site
state: Alabama
city: Phoenix
country: United States
facility: Novartis Investigator Site
state: Arizona
city: Searcy
country: United States
facility: Novartis Investigator Site
state: Arkansas
city: Fullerton
country: United States
facility: Novartis Investigator Site
state: California
city: Rancho Mirage
country: United States
facility: Novartis Investigative Site
state: California
city: Riverside
country: United States
facility: Novartis Investigator Site
state: California
city: San Diego
country: United States
facility: Novartis Investigator Site
state: California
city: Stockton
country: United States
facility: Novartis Investigator Site
state: California
city: Temecula
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: Glastonbury
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Stamford
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Clearwater
country: United States
facility: Novartis Investigator Site
state: Florida
city: Defuniak Springs
country: United States
facility: Novartis Investigator Site
state: Florida
city: Hollywood
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigator 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: Tamarac
country: United States
facility: Novartis Investigative Site
state: Florida
city: Tampa
country: United States
facility: Novartis Investigator Site
state: Florida
city: O'Fallon
country: United States
facility: Novartis Investigator Site
state: Illinois
city: Florence
country: United States
facility: Novartis Investigator Site
state: Kentucky
city: Madisonville
country: United States
facility: Novartis Investigator Site
state: Kentucky
city: Opelousas
country: United States
facility: Novartis Investigator Site
state: Louisiana
city: Columbia
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Edina
country: United States
facility: Novartis Investigator Site
state: Minnesota
city: Fridley
country: United States
facility: Novartis Investigator Site
state: Minnesota
city: Minneapolis
country: United States
facility: Novartis Investigator Site
state: Minnesota
city: Ozark
country: United States
facility: Novartis Investigator Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigator Site
state: Missouri
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: Las Vegas
country: United States
facility: Novartis Investigator Site
state: Nevada
city: Las Vegas
country: United States
facility: Novartis Investigator Site
state: Nevada
city: Lebanon
country: United States
facility: Novartis Investigator Site
state: New Hampshire
city: Cherry Hill
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Bayside
country: United States
facility: Novartis Investigative Site
state: New York
city: Great Neck
country: United States
facility: Novartis Investigative Site
state: New York
city: Lake Success
country: United States
facility: Novartis Investigative Site
state: New York
city: Larchmont
country: United States
facility: Novartis Investigative Site
state: New York
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Shelby
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cadiz
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Canton
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Toledo
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Eugene
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Medford
country: United States
facility: Novartis Investigator Site
state: Oregon
city: Phoenixville
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Charleston
country: United States
facility: Novartis Investigative site
state: South Carolina
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Easley
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Greenville
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: Cookeville
country: United States
facility: Novartis Investigator Site
state: Tennessee
city: Dickinson
country: United States
facility: Novartis Investigator Site
state: Texas
city: Ft. Worth
country: United States
facility: Novartis Investigator Site
state: Texas
city: McKinney
country: United States
facility: Novartis Investigator Site
state: Texas
city: Salt Lake City
country: United States
facility: Novartis Investigator Site
state: Utah
city: Fredericksburg
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Newport News
country: United States
facility: Novartis Investigative site
state: Virginia
city: Richmond
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: