Clinical trial NCT00900731: A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
Official title: A 12-week Treatment, Multicenter, Randomized, Parallel-group, Blinded, Double-dummy Study to Compare the Efficacy and Safety of Indacaterol (150 µg Once Daily [od]) Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
indacaterol
beta 2 agonist
tiotropium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-05-13
Enrollment: 1598
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 lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.


Eligibility criteria: Inclusion Criteria:

- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:

* a) Smoking history of at least 10 pack-years
* b) Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
* c) Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

Exclusion Criteria:

* Patients who have received systemic corticosteroids or antibiotics and/or was hospitalized for a COPD exacerbation 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) at End of Treatment (Week 12)
timeFrame: End of treatment (Week 12)
Secondary outcomes:
measure: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)
timeFrame: 5 minutes to 4 hours post-dose at the end of treatment (week 12)
measure: Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment
timeFrame: 12 weeks
measure: Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment
timeFrame: 12 weeks
measure: Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
timeFrame: Baseline, up to 12 weeks
measure: Change From Baseline in the Mean Number Per Day of Daytime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
timeFrame: Baseline, up to 12 weeks
measure: Change From Baseline in the Mean Number Per Day of Nighttime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
timeFrame: Baseline, up to 12 weeks
measure: Percentage of Days With no Rescue Medication Use During the 12 Weeks of Treatment
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
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country: United States
facility: Novartis Investigative Site
state: Alabama
city: Jasper
country: United States
facility: Novartis Investigator Site
state: Alabama
city: Phoenix
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state: Arizona
city: Tucson
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city: Anaheim
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city: Stockton
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city: Fort Collins
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city: South Miami
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state: Illinois
city: Evansville
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city: Topeka
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state: Kansas
city: Lafayette
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state: Louisiana
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facility: Novartis Investigative Center
state: Missouri
city: St Louis
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state: Missouri
city: Lincoln
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city: Henderson
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city: Albany
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city: Larchmont
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country: Belgium
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city: Gilly
country: Belgium
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city: Jambes
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city: Jette
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city: Liège
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city: Montigny-le-tilleul
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city: Oostende
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city: Saint Vith
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city: Yvoir
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city: Calgary
country: Canada
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city: Mississauga
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city: Moncton
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country: Colombia
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city: Medellin
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city: Aalborg
country: Denmark
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city: Frederiksberg
country: Denmark
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city: Næstved
country: Denmark
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city: Roskilde
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city: Sønderborg
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city: Vaerlose
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city: Viborg
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city: Helsinki
country: Finland
facility: Novartis Investigator Site
city: Jyväskylä
country: Finland
facility: Novartis Investigator Site
city: Lahti
country: Finland
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city: OYS
country: Finland
facility: Novartis Investigator Site
city: Pori
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city: Turku
country: Finland
facility: Novartis Investigator Site
city: Ambroise
country: France
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city: Antibes
country: France
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city: Beuvry
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city: Nantes
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city: Paris
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city: Pessac
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facility: Novartis Investigative Site
city: Pierre Benite
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city: Suresnes
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city: Vandoeuvre Les Nancys
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city: Bergisch Gladbach
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city: Berlin
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city: Bochum
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city: Bonn
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city: Buchholz
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city: Coburg
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city: Dueren
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city: Eggenfelden
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city: Eschwege
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facility: Novartis Investigator Site
city: Euskirchen
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facility: Novartis Investigator Site
city: Freudenberg
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city: Fürth
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city: Gelsenkirchen
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city: Gummersbach
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city: Hamburg
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city: Hannover
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city: Landsberg
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country: Spain
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city: Santander
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
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city: Vila-real
country: Spain
facility: Novartis Investigative Site
city: Basel
country: Switzerland
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city: Bellinzona
country: Switzerland
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city: Lugano
country: Switzerland
facility: Novartis Investigator Site
city: Muenchenstein
country: Switzerland
facility: Novartis Investigator Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Altunizade
country: Turkey
facility: Novartis Investigator Site
city: Ankara
country: Turkey
facility: Novartis Investigator Site
city: Aydin
country: Turkey
facility: Novartis Investigative Site
city: Büyükçekmece / Ýstanbul
country: Turkey
facility: Novartis Investigator Site
city: Fatih / Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigator Site
city: Kahramanmaras
country: Turkey
facility: Novartis Investigator Site
city: Mecidiyekoy/Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Mersin
country: Turkey
facility: Novartis Investigative Site
city: Soke / Aydin
country: Turkey
facility: Novartis Investigative Site
city: Yenisehir/Izmir
country: Turkey
facility: Novartis Investigative Site
city: Ash Vale
country: United Kingdom
facility: Novartis Investigator Site
city: Ashford
country: United Kingdom
facility: Novartis Investigator Site
city: Bolton
country: United Kingdom
facility: Novartis Investigator Site
city: Boscastle
country: United Kingdom
facility: Novartis Investigator Site
city: Bradford
country: United Kingdom
facility: Novartis Investigator Site
city: Chertsey
country: United Kingdom
facility: Novartis Investigator Site
city: East Horsley
country: United Kingdom
facility: Novartis Investigator Site
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Novartis Investigator Site
city: Plymouth
country: United Kingdom
facility: Novartis Investigator Site
city: Watford
country: United Kingdom
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Buhl R, Dunn LJ, Disdier C, Lassen C, Amos C, Henley M, Kramer B; INTENSITY study investigators. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD. Eur Respir J. 2011 Oct;38(4):797-803. doi: 10.1183/09031936.00191810. Epub 2011 May 26.