Clinical trial NCT00846586: 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: 2009-02-18
Enrollment: 1134
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:

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

Exclusion Criteria:

* Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization 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 or during the run-in period
* Patients with a body mass index less than 15 or more than 40 kg/m\^2
* 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 Treatment (Week 12)
timeFrame: From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)
Secondary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)
timeFrame: 24 hours post-dose at the end of treatment (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 Treatment (Week 12)
timeFrame: From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)
Other outcomes:
Locations:
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country: United States
facility: Novartis Investigator Site
state: Alabama
city: Mobile
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facility: Novartis Investigator Site
state: Alabama
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city: Tucson
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city: Fountain Valley
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city: National City
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city: Temecula
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city: Sarasota
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city: Atlanta
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city: Conyers
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state: Georgia
city: Normal
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state: Illinois
city: Iowa City
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state: Iowa
city: Kansas City
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state: Kansas
city: Lenexa
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state: Kansas
city: Topeka
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state: Kansas
city: Lafayette
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state: Louisiana
city: Metaire
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state: Louisiana
city: New Orleans
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state: Louisiana
city: Slidell
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state: Louisiana
city: Columbia
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state: Maryland
city: Brockton
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state: Massachusetts
city: Clarkston
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state: Michigan
city: Detroit
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state: Michigan
city: St Charles
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state: Missouri
city: Missoula
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city: Boys Town
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city: Omaha
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city: Omaha
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city: Las Vegas
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city: Lebanon
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city: Asbury Park
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city: Rochester
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city: Mooresville
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state: North Carolina
city: Winston-Salem
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state: North Carolina
city: Tulsa
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state: Oklahoma
city: Medford
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state: Oregon
city: Bethlehem
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state: Pennsylvania
city: Cumberland
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state: Rhode Island
city: Greenville
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state: South Carolina
city: Spartanburg
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state: South Carolina
city: Knoxville
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state: Tennessee
city: El Paso
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state: Texas
city: Houston
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state: Texas
city: Houston
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facility: Novartis Investigative Site
state: Texas
city: New Braunfels
country: United States
facility: Novartis Investigative Center
state: Texas
city: Newport News
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state: Virginia
city: Richmond
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state: Virginia
city: Richmond
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state: Virginia
city: Buenos Aires
country: Argentina
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city: Cordoba
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city: Corrientes
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city: Mendoza
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facility: Novartis Investigative SIte
city: Rosario
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city: Box Hill
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city: Clayton
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city: Garran
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city: Glebe
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city: Kogarah
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city: Nedlands
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city: Bogota
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city: Medellin
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city: Copenhagen
country: Denmark
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city: Fredericia
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city: Silkeborg
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city: Soeborg
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city: Vejle
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city: Berlin
country: Germany
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city: Cottbus
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city: Donaustauf
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city: Gelnhausen
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city: Leipzig
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city: Neu-Ulm
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city: Neuss
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city: Potsdam
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city: Rostock
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city: Schwabach
country: Germany
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city: Schwetzingen
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city: Straussberg
country: Germany
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city: Wiesbaden
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country: Guatemala
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city: Guatemala
country: Guatemala
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city: Guadalajara
country: Mexico
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city: Mexico City
country: Mexico
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country: Mexico
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city: Manila
country: Philippines
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city: Amanzimtoti
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city: Cape Town
country: South Africa
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country: South Africa
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city: Midrand
country: South Africa
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city: Umkomaas
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city: Alicante
country: Spain
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city: Barcelona
country: Spain
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city: Begonte
country: Spain
facility: Novartis Investigator Site
city: Cadiz
country: Spain
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city: Granollers
country: Spain
facility: Novartis Investigator Site
city: Jaén
country: Spain
facility: Novartis Investigative Site
city: La Coruna
country: Spain
facility: Novartis Investigator Site
city: Leon
country: Spain
facility: Novartis Investigator Site
city: Madrid
country: Spain
facility: Novartis Investigator Site
city: Pamplona
country: Spain
facility: Novartis Investigator Site
city: Torrelavega
country: Spain
facility: Novartis Investigator Site
city: Valencia
country: Spain
facility: Novartis Investigator Site
city: Vigo
country: Spain
facility: Novartis Investigator Site
city: Antalya
country: Turkey
facility: Novartis Investigator Site
city: Canakkale
country: Turkey
facility: Novartis Investigator Site
city: Isparta
country: Turkey
facility: Novartis Investigator Site
city: Istanbul
country: Turkey
facility: Novartis Investigator Site
city: Kartal
country: Turkey
facility: Novartis Investigator Site
city: Kayseri
country: Turkey
facility: Novartis Investigator Site
city: Kozlu / Zonguldak
country: Turkey
facility: Novartis Investigator Site
city: Malatya
country: Turkey
facility: Novartis Investigator Site
city: Manisa
country: Turkey
facility: Novartis Investigator Site
city: Mecidiyekoy/Istanbul
country: Turkey
facility: Novartis Investigator Site
city: Yenisehir/Izmir
country: Turkey
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
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.