Clinical trial NCT01079130: Efficacy and Safety of Different Doses of Indacaterol
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 Adult Patients With Persistent Asthma, Using Salmeterol as an Active Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Indacaterol
asthma
salmeterol
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-03-02
Enrollment: 511
Sex: ALL
Minimum age (years): 18
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:

* Patients with a diagnosis of asthma, and:

  1. Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening
  2. Prebronchodilator forced expiratory volume in 1 second (FEV1) at screening ≥50 and ≤90% of predicted normal
  3. An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling albuterol

Exclusion Criteria:

* Smoking history \>10 pack-years
* Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
* Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
* Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
* Patients who have had an intubation for a severe asthma exacerbation
* Patients who have had an emergency room visit for an asthma attack/asthma exacerbation within 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 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
* Patients who have ever received or are currently receiving omalizumab or chronic oral corticosteroid therapy

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment
timeFrame: Day 15 (after 2 weeks of treatment)
Secondary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment
timeFrame: Day 2 (after 1 day of treatment)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Novartis Investigator Site
state: Arizona
city: Scottsdale
country: United States
facility: Novartis Investigator Site
state: Arizona
city: Encinitas
country: United States
facility: Novartis Investigator Site
state: California
city: Huntington Beach
country: United States
facility: Novartis Investigator Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigator Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigator Site
state: California
city: Mission Viejo
country: United States
facility: Novartis Investigative Site
state: California
city: Orange
country: United States
facility: Novartis Investigator Site
state: California
city: Rancho Mirage
country: United States
facility: Novartis Investigator Site
state: California
city: Rolling Hills Estates
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: San Jose
country: United States
facility: Novartis Investigator Site
state: California
city: Stockton
country: United States
facility: Novartis Investigator Site
state: California
city: Colorado Springs
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Denver
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Engelwood
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Lakewood
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Stamford
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Waterbury
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Destin
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: 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: Winter Park
country: United States
facility: Novartis Investigative Site
state: Florida
city: Boise
country: United States
facility: Novartis Investigator Site
state: Idaho
city: Normal
country: United States
facility: Novartis Investigator Site
state: Illinois
city: Springfield
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Overland Park
country: United States
facility: Novartis Investigator Site
state: Kansas
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Lafayette
country: United States
facility: Novartis Investigator Site
state: Louisiana
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Columbia
country: United States
facility: Novartis Investigator Site
state: Maryland
city: Wheaton
country: United States
facility: Novartis Investigative Site
state: Maryland
city: North Dartmouth
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Columbia
country: United States
facility: Novartis Investigator Site
state: Missouri
city: Rolla
country: United States
facility: Novartis Investigator Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigator Site
state: Missouri
city: Warrensburg
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: Boys Town
country: United States
facility: Novartis Investigator Site
state: Nebraska
city: Ocean
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Skillman
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Raleigh
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cadiz
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Maumee
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigator Site
state: Oklahoma
city: Lake Oswego
country: United States
facility: Novartis Investigator Site
state: Oregon
city: Medford
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigator Site
state: Oregon
city: Erie
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Phoenixville
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Upland
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Lincoln
country: United States
facility: Novartis Investigative Site
state: Rhode Island
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: North Charleston
country: United States
facility: Novartis Investigative site
state: South Carolina
city: Austin
country: United States
facility: Novartis Investigator Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigator Site
state: Texas
city: El Paso
country: United States
facility: Novartis Investigator Site
state: Texas
city: El Paso
country: United States
facility: Novartis Investigator Site
state: Texas
city: Georgetown
country: United States
facility: Novartis Investigator Site
state: Texas
city: North Richland Hills
country: United States
facility: Novartis Investigator Site
state: Texas
city: Waco
country: United States
facility: Novartis Investigator Site
state: Texas
city: Seattle
country: United States
facility: Novartis Investigator Site
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: