Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01908140
Last Updated: 2016-03-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
933 participants
INTERVENTIONAL
2013-09-30
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Aclidinium Bromide / Formoterol Fumarate
Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
Aclidinium Bromide / Formoterol Fumarate
Salmeterol / Fluticasone propionate
Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
Salmeterol / Fluticasone
Interventions
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Aclidinium Bromide / Formoterol Fumarate
Salmeterol / Fluticasone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years
* Patients with a clinical diagnosis of COPD according to GOLD guidelines 2013, with a post-bronchodilator FEV1 \<80%, and FEV1/FVC \< 70% at Screening Visits
* Symptomatic patients with a COPD assessment test (CAT) ≥10 at Screening and Randomisation Visits
* Patient must be able to perform repeatable pulmonary function testing for FEV1 according to ATS/ERS 2005 criteria at Screening Visits
* Patients eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained
Exclusion Criteria
* Development of a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the Screening Visit or during the run-in period
* Clinically significant respiratory conditions
* Type I or uncontrolled Type II diabetes, uncontrolled hypo- or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
* Patients who, in the investigator's opinion, may need to start a pulmonary rehabilitation programme during the study and/or patients who started/finished it within 3 months prior to Screening Visit
* Use of long-term oxygen therapy (≥15 hours/day)
* Patients treated on daily basis with triple therapy (LABA+LAMA+ICS) within 4 weeks prior to the Screening Visit
* Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers
* Clinically significant cardiovascular conditions
* Patient with clinically relevant abnormalities in the results of the clinical laboratory tests, ECG parameters or in the physical examination at the Screening Visit
* Patient with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm)
* Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy
* Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis
* History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer
* Patient with any other serious or uncontrolled physical or mental dysfunction
* Patient with a history (within 2 years prior to Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment
* Patient unlikely to be cooperative or that can't comply with the study procedures
* Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Screening Visit
* Patient who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication
* Any other conditions that, in the investigator's opinion, might indicate the patient to be unsuitable for the study
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Esther Garcia, Ph.D.
Role: STUDY_DIRECTOR
Global Medicines Development
Locations
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Almirall Investigational Site
Feldbach, , Austria
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Feldkirch, , Austria
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Grieskirchen, , Austria
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Linz, , Austria
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Salzburg, , Austria
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Dimitrovgrad, , Bulgaria
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Gabrovo, , Bulgaria
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Kozloduy, , Bulgaria
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Petrich, , Bulgaria
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Plovdiv, , Bulgaria
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Razgrad, , Bulgaria
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Stara Zagora, , Bulgaria
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Vidin, , Bulgaria
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Moncton, New Brunswick, Canada
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Toronto, Ontario, Canada
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Saint Romuald, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Karlovy Vary, , Czechia
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Kralupy nad Vltavou, , Czechia
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Liberec, , Czechia
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Ostrava - Hrabuvka, , Czechia
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Rokycany, , Czechia
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Strakonice, , Czechia
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Nîmes, , France
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Perpignan, , France
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Vieux-Condé, , France
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bochum, , Germany
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Bonn, , Germany
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Cologne, , Germany
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Cottbus, , Germany
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Dortmund, , Germany
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Dresden, , Germany
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Frankfurt, , Germany
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Frankfurt, , Germany
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Gauting, , Germany
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Großhansdorf, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Jena, , Germany
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Leipzig, , Germany
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Marburg, , Germany
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Munich, , Germany
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Rüdersdorf, , Germany
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Schwabach, , Germany
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Wiesbaden, , Germany
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Wiesloch, , Germany
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Witten, , Germany
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Balassagyarmat, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Komárom, , Hungary
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Nyíregyháza, , Hungary
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Pécs, , Hungary
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Százhalombatta, , Hungary
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Szigetszentmiklós, , Hungary
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Vásárosnamény, , Hungary
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Pisa, , Italy
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Pordenone, , Italy
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Trieste, , Italy
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Klaipėda, , Lithuania
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Vilnius, , Lithuania
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Almere Stad, , Netherlands
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Beek, , Netherlands
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Eindhoven, , Netherlands
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Hoofddorp, , Netherlands
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Leeuwarden, , Netherlands
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Rotterdam, , Netherlands
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Bialystok, , Poland
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Bialystok, , Poland
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Bialystok, , Poland
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Gdansk, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Ostrowiec Świętokrzyski, , Poland
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Piła, , Poland
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Poznan, , Poland
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Proszowice, , Poland
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Sopot, , Poland
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Szczecin, , Poland
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Tarnów, , Poland
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Tczew, , Poland
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Warsaw, , Poland
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Wilkowice-Bystra, , Poland
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Belville, , South Africa
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Cape Town, , South Africa
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Gauteng, , South Africa
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Gauteng, , South Africa
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Middelburg, , South Africa
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Pretoria, , South Africa
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Somerset West, , South Africa
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Alicante, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Elda, , Spain
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Laredo, , Spain
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Madrid, , Spain
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Palma de Mallorca, , Spain
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Sant Boi de Llobregat, , Spain
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Santander, , Spain
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Seville, , Spain
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Birmingham, , United Kingdom
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Chorley, , United Kingdom
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Glasgow, , United Kingdom
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Liverpool, , United Kingdom
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Manchester, , United Kingdom
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Middlesex, , United Kingdom
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Reading, , United Kingdom
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Sidcup, , United Kingdom
Countries
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References
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Vogelmeier C, Paggiaro PL, Dorca J, Sliwinski P, Mallet M, Kirsten AM, Beier J, Seoane B, Segarra RM, Leselbaum A. Efficacy and safety of aclidinium/formoterol versus salmeterol/fluticasone: a phase 3 COPD study. Eur Respir J. 2016 Oct;48(4):1030-1039. doi: 10.1183/13993003.00216-2016. Epub 2016 Aug 4.
Related Links
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Other Identifiers
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2013-000116-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M/40464/39
Identifier Type: -
Identifier Source: org_study_id
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