Clinical trial NCT00845728: Exacerbation Study
Official title: A Phase IIIb Multicenter, 52 Week Treatment, Randomized, Blinded, Double Dummy, Parallel Group Efficacy Study Comparing the Effect of Inhaled Indacaterol 150 µg o.d. vs Inhaled Tiotropium 18 µg o.d. on Lung Function, Rate of Exacerbations and Related Outcomes in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Indacaterol
Tiotropium
COPD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-02-18
Enrollment: 3439
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 compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks


Eligibility criteria: Inclusion Criteria:

* Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure
* Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe COPD and including:

  1. Smoking history of at least 10 pack years, both current and ex-smokers are eligible
  2. A documented history of at least 1 moderate or severe exacerbation in the previous 12 months

Exclusion Criteria:

* Patients who have received systemic corticosteroids and/or antibiotics 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 may apply

Primary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1).
timeFrame: 12 weeks
Secondary outcomes:
measure: Rate of COPD Exacerbations
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Capital Federal
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Pilar
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Novartis Investigative Site
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos aires
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facility: Novartis Investigative Site
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country: Argentina
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city: Adelaide
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city: Heidelberg
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city: Helsinki
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city: HUS
country: Finland
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city: Jyvaskyla
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city: Pori
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city: Porvoo
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city: Lyon cedex 04
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city: Montpellier
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city: Vandoeuvre les Nancy
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city: Berlin
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city: Berlin
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city: Berlin
country: Germany
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city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
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city: Berlin
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city: Berlin
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city: Bonn
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city: Borstel
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facility: Novartis Investigative Site
city: Dachau
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facility: Novartis Investigative Site
city: Euskirchen
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city: Frankfurt
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city: Fürstenwalde/Spree
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facility: Novartis Investigative Site
city: Hamburg
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city: Hamburg
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city: Hamburg
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facility: Novartis Investigative Site
city: Hamburg
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city: Hoyerswerda
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facility: Novartis Investigative Site
city: Landsberg
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city: Leipzig
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city: Mainz
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city: Marburg
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facility: Novartis Investigative Site
city: Muenchen
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city: Muenchen
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facility: Novartis Investigative Site
city: Muenchen
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city: Muenchen
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facility: Novartis Investigative Site
city: München
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state: Gujrat
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state: Tamil Nadu
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city: Nagpur - Maharastra
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state: MI
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country: Mexico
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city: Lisboa
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city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Bucharest
country: Romania
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state: District 3
city: Brasov
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state: Jud. Brasov
city: Constanta
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facility: Novartis Investigative Site
state: Jud. Constanta
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state: Jud. Iasi
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Cluj-Napoca
country: Romania
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
state: Tatarstan Republic
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Samara
country: Russian Federation
facility: Novartis Investigative Site
city: Sankt-Peterburg
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St.-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Spisska Nova Ves
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Lucenec
country: Slovakia
facility: Novartis Investigative Site
city: Nove Zamky
country: Slovakia
facility: Novartis Investigative Site
city: Poprad
country: Slovakia
facility: Novartis Investigative Site
city: Bloemfontein
country: South Africa
facility: Novartis Investigative Site
city: Bloemfontein
country: South Africa
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Durban
country: South Africa
facility: Novartis Investigative Site
city: Jerez de La Frontera
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sanlúcar de Barrameda
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Gijon
country: Spain
facility: Novartis Investigative Site
state: Asturias
city: Illescas
country: Spain
facility: Novartis Investigative Site
state: Castilla la Mancha
city: Valladolid
country: Spain
facility: Novartis Investigative Site
state: Castilla y Leon
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Salt
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Sant Boi de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Terrassa
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Vic
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Alzira
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Requena
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Caceres
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: Mérida
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: Plasencia
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: La Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Lugo
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Pozuelo de Alarcón
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Göteborg
country: Sweden
facility: Novartis Investigative Site
city: Göteborg
country: Sweden
facility: Novartis Investigative Site
city: Luleå
country: Sweden
facility: Novartis Investigative Site
city: Lund
country: Sweden
facility: Novartis Investigative Site
city: Malmö
country: Sweden
facility: Novartis Investigative Site
city: Skellefteå
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Sundsvall
country: Sweden
facility: Novartis Investigative Site
city: Faltigberg-Wald
country: Switzerland
facility: Novartis Investigative Site
state: ZH
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Crans-Montana
country: Switzerland
facility: Novartis Investigative Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
city: St. Gallen
country: Switzerland
facility: Novartis Investigative Site
city: Thun
country: Switzerland
facility: Novartis Investigative Site
city: Winterthur
country: Switzerland
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei County
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
city: Songkla
country: Thailand
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Canakkale
country: Turkey
facility: Novartis Investigative Site
city: Diskapi / Ankara
country: Turkey
facility: Novartis Investigative Site
city: Emek / Ankara
country: Turkey
facility: Novartis Investigative Site
city: Gaziantep
country: Turkey
facility: Novartis Investigative Site
city: Isparta
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Kahramanmaras
country: Turkey
facility: Novartis Investigative Site
city: Kecioren / Ankara
country: Turkey
facility: Novartis Investigative Site
city: Kozlu / Zonguldak
country: Turkey
facility: Novartis Investigative Site
city: Malatya
country: Turkey
facility: Novartis Investigative Site
city: Mersin
country: Turkey
facility: Novartis Investigative Site
city: Yenisehir/Izmir
country: Turkey
facility: Novartis Investigative Site
city: Swansea
country: United Kingdom
facility: Novartis Investigative Site
state: England
city: Newcastle Upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
state: Newcastle
city: Ash Vale
country: United Kingdom
facility: Novartis Investigative Site
state: Surrey
city: Crawley
country: United Kingdom
facility: Novartis Investigative Site
state: West Sussex
city: Belfast
country: United Kingdom
facility: Novartis Investigative Site
city: Bexhill-on-Sea
country: United Kingdom
facility: Novartis Investigative Site
city: Bradford
country: United Kingdom
facility: Novartis Investigative Site
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: Cambridge
country: United Kingdom
facility: Novartis Investigative Site
city: Lancashire
country: United Kingdom
facility: Novartis Investigative Site
city: Lancashire
country: United Kingdom
facility: Novartis Investigative Site
city: Liverpool
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Newport
country: United Kingdom
facility: Novartis Investigative Site
city: Stockport
country: United Kingdom
facility: Novartis Investigative Site
city: Stockport
country: United Kingdom
facility: Novartis Investigative Site
city: Surrey
country: United Kingdom
facility: Novartis Investigative Site
city: Warminster
country: United Kingdom
facility: Novartis Investigative Site
city: Watford
country: United Kingdom
facility: Novartis Investigative Site
city: Windsor
country: United Kingdom
facility: Novartis Investigative Site
city: Valencia
country: Venezuela
facility: Novartis Investigative Site
state: Estado Carabobo
city: Barquisimeto
country: Venezuela
facility: Novartis Investigative Site
state: Estado Lara
city: Maracaibo
country: Venezuela
facility: Novartis Investigative Site
state: Estado Zulia
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Decramer ML, Chapman KR, Dahl R, Frith P, Devouassoux G, Fritscher C, Cameron R, Shoaib M, Lawrence D, Young D, McBryan D; INVIGORATE investigators. Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study. Lancet Respir Med. 2013 Sep;1(7):524-33. doi: 10.1016/S2213-2600(13)70158-9. Epub 2013 Aug 21.