Clinical trial NCT00821093: Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD)
Official title: A 12 Week Treatment, Multi-center, Randomized, Parallel Group, Double Blind, Double Dummy Study to Assess the Superiority of Indacaterol (150 µg o.d.) Via a SDDPI in Patients With Moderate to Severe COPD, Using Salmeterol (50 µg b.i.d.) as an Active Comparator Delivered Via a DISKUS Inhaler
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: respiratory
dyspnea
breathlessness
COPD
indacaterol
long-acting β2-agonist
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-01-13
Enrollment: 1123
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 safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.


Eligibility criteria: Inclusion Criteria:

* Adults aged ≥ 40 years
* Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the GOLD Guidelines, 2007) and:

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

Exclusion Criteria:

* Patients who have received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
* Patients requiring long-term oxygen therapy (\> 15 h a day) for chronic hypoxemia
* 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
* Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time
* Patients with a history of long QT syndrome or whose QTc interval (Fridericia's) measured at screening is prolonged
* Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period
* Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria applied to the study.

Primary outcomes:
measure: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 11 Hours 45 Minutes Post-dose at the End of the Study (Week 12, Day 84)
timeFrame: From 5 minutes to 11 hours 45 minutes 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: 24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Novartis Investigator Site
state: Alabama
city: Fairhope
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: Buena Park
country: United States
facility: Novartis Investigator Site
state: California
city: Encinitas
country: United States
facility: Novartis Investigator Site
state: California
city: Fullerton
country: United States
facility: Novartis Investigator Site
state: California
city: Rancho Mirage
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facility: Novartis Investigator Site
state: California
city: Riverside
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facility: Novartis Investigator Site
state: California
city: San Diego
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facility: Novartis Investigator Site
state: California
city: Torrance
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state: California
city: Walnut Creek
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state: California
city: Fort Collins
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state: Colorado
city: Wheat Ridge
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facility: Novartis Investigative Site
state: Colorado
city: Stamford
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state: Connecticut
city: Newark
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facility: Novartis Investigative Site
state: Delaware
city: Clearwater
country: United States
facility: Novartis Investigative Center
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: South Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Tamarac
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city: Tampa
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city: Tampa
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state: Florida
city: Marietta
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state: Georgia
city: Normal
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state: Illinois
city: River Forest
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state: Illinois
city: Skokie
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state: Illinois
city: Olathe
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state: Kansas
city: Wichita
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city: New Orleans
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city: Ann Arbor
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city: Livonia
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city: Minneapolis
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city: St Charles
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state: Missouri
city: St Louis
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state: Missouri
city: Lincoln
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state: Nebraska
city: Omaha
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city: Henderson
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city: Reno
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city: Summit
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city: Larchmont
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city: Hickory
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city: Columbus
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city: Willoughby Hills
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city: Tulsa
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city: Eugene
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city: Medford
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city: Portland
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state: Pennsylvania
city: Charleston
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state: South Carolina
city: Greenville
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state: South Carolina
city: North Charleston
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state: South Carolina
city: Spartanburg
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facility: Novartis Investigative site
state: South Carolina
city: Union
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state: South Carolina
city: El Paso
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state: Texas
city: Fort Worth
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state: Texas
city: Houston
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state: Texas
city: San Antonio
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state: Texas
city: Abingdon
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state: Virginia
city: Richmond
country: United States
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state: Virginia
city: Spokane
country: United States
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state: Washington
city: Tacoma
country: United States
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state: Washington
city: Milwaukee
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state: Wisconsin
city: Cvikov
country: Czech Republic
facility: Novartis Investigator Site
city: Kyjov
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facility: Novartis Investigator Site
city: Lovosice
country: Czech Republic
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city: Neratovice
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city: Ostrava
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city: Pardubice
country: Czech Republic
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city: Prague
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city: Teplice
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facility: Novartis Investigator Site
city: Aschaffenburg
country: Germany
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city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Backnang
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigator Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Borstel
country: Germany
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city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Duisburg
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigator Site
city: Geesthacht
country: Germany
facility: Novartis Investigative Site
city: Hagen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Karlsruhe
country: Germany
facility: Novartis Investigative Site
city: Kiel
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facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigator Site
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city: Mainz
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city: Marburg
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city: Neumuenster
country: Germany
facility: Novartis Investigative Site
city: Oschersleben
country: Germany
facility: Novartis Investigative SIte
city: Ruedersdorf
country: Germany
facility: Novartis Investigative Site
city: Weyhe
country: Germany
facility: Novartis Investigative Site
city: Wiesloch
country: Germany
facility: Novartis Investigative Site
city: Witten
country: Germany
facility: Novartis Investgative Site
city: Budapest
country: Hungary
facility: Novartis Investigator Site
city: Debrecen
country: Hungary
facility: Novartis Investigator Site
city: Deszk
country: Hungary
facility: Novartis Investigative Site
city: Mosonmagyarovar
country: Hungary
facility: Novartis Investigator Site
city: Nyiregyhaza
country: Hungary
facility: Novartis Investigator Site
city: Tatabanya
country: Hungary
facility: Novartis Investigator Site
city: Torokbalint
country: Hungary
facility: Novartis Investigator Site
city: Chennai
country: India
facility: Novartis Investigator Site
city: Hyderabad
country: India
facility: Novartis Investigator Site
city: Jaipur
country: India
facility: Novartis Investigator Site
city: Mangalore
country: India
facility: Novartis Investigator Site
city: Panjim
country: India
facility: Novartis Investigator Site
city: Pune
country: India
facility: Novartis Investigator Site
city: Trivandrum
country: India
facility: Novartis Investigator Site
city: Vellore
country: India
facility: Novartis Investigator Site
city: Bojnice
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigator Site
city: Humenne
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Liptovsky Hradok
country: Slovakia
facility: Novartis Investigator Site
city: Partizanske
country: Slovakia
facility: Novartis Investigative Site
city: Spisska Nova Ves
country: Slovakia
facility: Novartis Investigative Site
city: Alicante
country: Spain
facility: Novartis Investigator Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Caceres
country: Spain
facility: Novartis Investigative Site
city: Cordoba
country: Spain
facility: Novartis Investigative Site
city: La Coruna
country: Spain
facility: Novartis Investigative Site
city: Merida
country: Spain
facility: Novartis Investigative Site
city: Orense
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Altunizade
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigator Site
city: Izmir
country: Turkey
facility: Novartis Investigator Site
city: Kartal/Istanbul
country: Turkey
facility: Novartis Investigator Site
city: Kinikli / Denizli
country: Turkey
facility: Novartis Investigative Site
city: Mersin
country: Turkey
facility: Novartis Investigative Site
city: Yenisehir/Izmir
country: Turkey
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceticals
role: STUDY_DIRECTOR
References:
citation: Korn S, Kerwin E, Atis S, Amos C, Owen R, Lassen C; INSIST study group. Indacaterol once-daily provides superior efficacy to salmeterol twice-daily in COPD: a 12-week study. Respir Med. 2011 May;105(5):719-26. doi: 10.1016/j.rmed.2011.02.008. Epub 2011 Mar 1.