Clinical trial NCT01068600: Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks
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: 2010-02-15
Enrollment: 318
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 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 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 for 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 may apply

Primary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment
timeFrame: after 12 weeks
Secondary outcomes:
measure: Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment
timeFrame: after 12 weeks
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Jasper
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 Investigator Site
state: Arizona
city: Fullerton
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: Riverside
country: United States
facility: Novartis Investigator Site
state: California
city: Clearwater
country: United States
facility: Novartis Investigative Site
state: Florida
city: Clearwater
country: United States
facility: Novartis Investigative Site
state: Florida
city: Hollywood
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative site
state: Florida
city: Tampa
country: United States
facility: Novartis Investigative Site
state: Florida
city: Winter Park
country: United States
facility: Novartis Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Normal
country: United States
facility: Novartis Investigator Site
state: Illinois
city: Iowa City
country: United States
facility: Novartis Investigator Site
state: Iowa
city: Madisonville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Novartis Investigator Site
state: Louisiana
city: Opelousas
country: United States
facility: Novartis Investigator Site
state: Louisiana
city: St. Charles
country: United States
facility: Novartis Investigator Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigator Site
state: Missouri
city: Lincoln
country: United States
facility: Novartis Investigator Site
state: Nebraska
city: Omaha
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: Cherry Hill
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Albuquerque
country: United States
facility: Novartis Investigator Site
state: New Mexico
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: Shelby
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Canton
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Marion
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Eugene
country: United States
facility: Novartis Investigator Site
state: Oregon
city: Medford
country: United States
facility: Novartis Investigator Site
state: Oregon
city: Cumberland
country: United States
facility: Novartis Investigative Site
state: Rhode Island
city: Pawtucket
country: United States
facility: Novartis Investigative Site
state: Rhode Island
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: North 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: Arlington
country: United States
facility: Novartis Investigator Site
state: Texas
city: Dickinson
country: United States
facility: Novartis Investigator Site
state: Texas
city: El Paso
country: United States
facility: Novartis Investigator Site
state: Texas
city: McKinney
country: United States
facility: Novartis Investigator Site
state: Texas
city: South Burlington
country: United States
facility: Novartis Investigative Site
state: Vermont
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
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.