Clinical trial NCT00877383: Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
Official title: A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: chronic obstructive pulmonary disease
COPD
indacaterol
tiotropium
bronchodilation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-04-07
Enrollment: 1142
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 assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD).


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, 2007) and:

  * Smoking history of at least 10 pack-years
  * Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30% of the predicted normal value
  * Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

Exclusion Criteria:

* Patients who have received systemic corticosteroids and/or antibiotics and/or was hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
* 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: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of the Study (Week 12, Day 84)
timeFrame: From 5 minutes to 8 hours post-dose at the end of the study (Week 12, Day 84)
Secondary 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: End of the study (Week 12 + 1 day, Day 85)
measure: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1
timeFrame: From 5 minutes to 8 hours post-dose on Day 1
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2
timeFrame: 24 hours post-dose on Day 2
measure: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1
timeFrame: From 5 minutes to 4 hours post-dose on Day 1
measure: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of the Study (Week 12, Day 84)
timeFrame: From 5 minutes to 4 hours post-dose at the end of the study (Week 12, Day 84)
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Novartis Investigator Site
state: Alabama
city: Birmingham
country: United States
facility: Novartis Investigator Site
state: Alabama
city: Jasper
country: United States
facility: Novartis Investigator Site
state: Alabama
city: Mobile
country: United States
facility: Novartis Investigator 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: Phoenix
country: United States
facility: Novartis Investigator Site
state: Arizona
city: Scottsdale
country: United States
facility: Novartis Investigator Site
state: Arizona
city: Little Rock
country: United States
facility: Novartis Investigator Site
state: Arkansas
city: Buena Park
country: United States
facility: Novartis Investigator Site
state: California
city: Fullerton
country: United States
facility: Novartis Investigator Site
state: California
city: Mission Viejo
country: United States
facility: Novartis Investigator Site
state: California
city: San Ramon
country: United States
facility: Novartis Investigator Site
state: California
city: Santa Barbara
country: United States
facility: Novartis Investigator Site
state: California
city: Sepulveda
country: United States
facility: Novartis Investigator Site
state: California
city: Spring Valley
country: United States
facility: Novartis Investigator Site
state: California
city: Torrance
country: United States
facility: Novartis Investigator Site
state: California
city: Torrance
country: United States
facility: Novartis Investigator Site
state: California
city: Vista
country: United States
facility: Novartis Investigator Site
state: California
city: Boulder
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Centennial
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Colorado Springs
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Denver
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Glastonbury
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Waterbury
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Clearwater
country: United States
facility: Novartis Investigator Site
state: Florida
city: Destin
country: United States
facility: Novartis Investigator Site
state: Florida
city: Maitland
country: United States
facility: Novartis Investigator Site
state: Florida
city: Miami Beach
country: United States
facility: Novartis Investigator Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigator Site
state: Florida
city: Ocala
country: United States
facility: Novartis Investigator Site
state: Florida
city: Pensacola
country: United States
facility: Novartis Investigator Site
state: Florida
city: Pensacola
country: United States
facility: Novartis Investigator Site
state: Florida
city: Pensacola
country: United States
facility: Novartis Investigator Site
state: Florida
city: Port Orange
country: United States
facility: Novartis Investigator Site
state: Florida
city: South Miami
country: United States
facility: Novartis Investigator Site
state: Florida
city: Tamarac
country: United States
facility: Novartis Investigator Site
state: Florida
city: Tampa
country: United States
facility: Novartis Investigator Site
state: Florida
city: Tampa
country: United States
facility: Novartis Investigator Site
state: Florida
city: Couer D'Alene
country: United States
facility: Novartis Investigator Site
state: Idaho
city: Downers Grove
country: United States
facility: Novartis Investigator Site
state: Illinois
city: Elk Grove Village
country: United States
facility: Novartis Investigator Site
state: Illinois
city: River Forest
country: United States
facility: Novartis Investigator Site
state: Illinois
city: Springfield
country: United States
facility: Novartis Investigator Site
state: Illinois
city: Shawnee
country: United States
facility: Novartis Investigator Site
state: Kansas
city: Crescent Springs
country: United States
facility: Novartis Investigator Site
state: Kentucky
city: Lexington
country: United States
facility: Novartis Investigator Site
state: Kentucky
city: Louisville
country: United States
facility: Novartis Investigator Site
state: Kentucky
city: Shreveport
country: United States
facility: Novartis Investigator Site
state: Louisiana
city: Waldorf
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Burlington
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Troy
country: United States
facility: Novartis Investigator Site
state: Michigan
city: Chaska
country: United States
facility: Novartis Investigator Site
state: Minnesota
city: Edina
country: United States
facility: Novartis Investigator Site
state: Minnesota
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Rochester
country: United States
facility: Novartis Investigator Site
state: Minnesota
city: St Paul
country: United States
facility: Novartis Investigator Site
state: Minnesota
city: Columbia
country: United States
facility: Novartis Investigator Site
state: Missouri
city: Kansas City
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: St. Louis
country: United States
facility: Novartis Investigator Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigator Site
state: Missouri
city: Billings
country: United States
facility: Novartis Investigator Site
state: Montana
city: Kalispell
country: United States
facility: Novartis Investigator 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: Papillion
country: United States
facility: Novartis Investigator Site
state: Nebraska
city: Henderson
country: United States
facility: Novartis Investigator Site
state: Nevada
city: Brick
country: United States
facility: Novartis Investigative Site
state: New Jersey
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: 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: Larchmont
country: United States
facility: Novartis Investigative site
state: New York
city: Burlington
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Charlotte
country: United States
facility: Novartis Investigator Site
state: North Carolina
city: Charlotte
country: United States
facility: Novartis Investigator Site
state: North Carolina
city: Raleigh
country: United States
facility: Novartis Investigative Center
state: North Carolina
city: Shelby
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Statesville
country: United States
facility: Novartis Investigator Site
state: North Carolina
city: Winston Salem
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Fargo
country: United States
facility: Novartis Investigator Site
state: North Dakota
city: Grand Forks
country: United States
facility: Novartis Investigator Site
state: North Dakota
city: Akron
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Cincinnati
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Cleveland
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Toledo
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigator Site
state: Oklahoma
city: Eugene
country: United States
facility: Novartis Investigator Site
state: Oregon
city: Allentown
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Beaver
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Erie
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigative site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Phoenixville
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pawtucket
country: United States
facility: Novartis Investigative Site
state: Rhode Island
city: Providence
country: United States
facility: Novartis Investigative Site
state: Rhode Island
city: Charleston
country: United States
facility: Novartis Investigator Site
state: South Carolina
city: Easley
country: United States
facility: Novartis Investigator Site
state: South Carolina
city: Greenville
country: United States
facility: Novartis Investigator Site
state: South Carolina
city: North Charleston
country: United States
facility: Novartis Investigator Site
state: South Carolina
city: Spartanburg
country: United States
facility: Novartis Investigator Site
state: South Carolina
city: Union
country: United States
facility: Novartis Investigator Site
state: South Carolina
city: Dallas
country: United States
facility: Novartis Investigator Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigator Site
state: Texas
city: Fort Worth
country: United States
facility: Novartis Investigator Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigator Site
state: Texas
city: Tyler
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 Investigative Site
state: Virginia
city: Fredericks
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Renton
country: United States
facility: Novartis Investigator Site
state: Washington
city: Spokane
country: United States
facility: Novartis Investigator Site
state: Washington
city: Morgantown
country: United States
facility: Novartis Investigative Site
state: West Virginia
city: Gatineau
country: Canada
facility: Novartis Investigator Site
city: Joliette
country: Canada
facility: Novartis Investigator Site
city: Mirabel
country: Canada
facility: Novartis Investigator Site
city: Mississauga
country: Canada
facility: Novartis Investigator Site
city: Montreal
country: Canada
facility: Novartis Investigator Site
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Sainte-Foy
country: Canada
facility: Novartis Investigator Site
city: Sherbrooke
country: Canada
facility: Novartis Investigator Site
city: St-Jerome
country: Canada
facility: Novartis Investigator Site
city: Toronto
country: Canada
facility: Novartis Investigator Site
city: Trois-Rivières
country: Canada
facility: Novartis Investigator Site
city: Windsor
country: Canada
facility: Novartis Investigator Site
city: Armenia
country: Colombia
facility: Novartis Investigative Site
city: Barranquilla
country: Colombia
facility: Novartis Investigator Site
city: Bogota
country: Colombia
facility: Novartis Investigative Site
city: Cali
country: Colombia
facility: Novartis Investigator Site
city: Karlovy Vary
country: Czech Republic
facility: Novartis Investigative Site
city: Kladno
country: Czech Republic
facility: Novartis Investigative Site
city: Kromeriz
country: Czech Republic
facility: Novartis Investigative Site
city: Liberec
country: Czech Republic
facility: Novartis Investigative SIte
city: Rokycany
country: Czech Republic
facility: Novartis Investigative Site
city: Strakonice
country: Czech Republic
facility: Novartis Investigative Site
city: Trebic
country: Czech Republic
facility: Novartis Investigative Site
city: Erd
country: Hungary
facility: Novartis Investigative Site
city: Füzesabony
country: Hungary
facility: Novartis Investigative Site
city: Gyor
country: Hungary
facility: Novartis Investigator Site
city: Százhalombatta
country: Hungary
facility: Novartis Investgative Site
city: Ahmedabad
country: India
facility: Novartis Investigator Site
city: Bangalore
country: India
facility: Novartis Investigator Site
city: Coimbatore
country: India
facility: Novartis Investigator Site
city: Hyderabad
country: India
facility: Novartis Investigative Site
city: Indore
country: India
facility: Novartis Investigative Site
city: Jaipur
country: India
facility: Novartis Investigative Site
city: Ludhiana
country: India
facility: Novartis Investigator Site
city: Panjim
country: India
facility: Novartis Investigative Site
city: Trivandrum
country: India
facility: Novartis Investigator Site
city: Almelo
country: Netherlands
facility: Novartis Investigative Site
city: Breda
country: Netherlands
facility: Novartis Investigative Site
city: Heerlen
country: Netherlands
facility: Novartis Investigative Site
city: Helmond
country: Netherlands
facility: Novartis Investigative Site
city: Veldhoven
country: Netherlands
facility: Novartis Investigative Site
city: Zutphen
country: Netherlands
facility: Novartis Investigative Site
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Bardejov
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigator Site
city: Martin
country: Slovakia
facility: Novartis Investigative Site
city: Poprad
country: Slovakia
facility: Novartis Investigative Site
city: Povazska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Štúrovo
country: Slovakia
facility: Novartis Investigative Site
city: Alicante
country: Spain
facility: Novartis Investigative Site
city: Almeria
country: Spain
facility: Novartis Investigative Site
city: Baracaldo
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigator Site
city: Palma de Mallorca
country: Spain
facility: Novartis Investigative Site
city: Pozuelo de Alarcón
country: Spain
facility: Novartis Investigator Site
city: Riudecols
country: Spain
facility: Novartis Investigator Site
city: San Boi De Llobregat
country: Spain
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigator Site
city: Vilassar de Mar
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceticals
role: STUDY_DIRECTOR
References:
citation: Mahler DA, D'Urzo A, Bateman ED, Ozkan SA, White T, Peckitt C, Lassen C, Kramer B; INTRUST-1 and INTRUST-2 study investigators. Concurrent use of indacaterol plus tiotropium in patients with COPD provides superior bronchodilation compared with tiotropium alone: a randomised, double-blind comparison. Thorax. 2012 Sep;67(9):781-8. doi: 10.1136/thoraxjnl-2011-201140. Epub 2012 Apr 27.