Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT ID: NCT01001494
Last Updated: 2017-01-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
828 participants
INTERVENTIONAL
2009-10-31
2010-11-30
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
DOUBLE
Study Groups
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Aclidinium bromide 200 μg bid
Aclidinium bromide 200 μg twice-daily via inhalation
Aclidinium bromide 200 μg bid
Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
Aclidininum bromide 400 μg bid
Aclidinium bromide 400 μg twice-daily via inhalation
Aclidinium bromide 400 μg bid
Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
Placebo
Placebo
Placebo
Placebo twice-daily by inhalation for 24 weeks
Interventions
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Aclidinium bromide 200 μg bid
Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
Aclidinium bromide 400 μg bid
Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
Placebo
Placebo twice-daily by inhalation for 24 weeks
Eligibility Criteria
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Inclusion Criteria
* Post-salbutamol (FEV1) \< 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC \< 70%.
* Current or ex-smokers of ≥10 pack-years.
Exclusion Criteria
* No evidence of an exacerbation within 6 weeks prior to the screening visit.
* No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
* No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
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, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Almirall Investigational Sites#4
Benešov, , Czechia
Almirall Investigational Sites#9
Jaroměř, , Czechia
Almirall Investigational Sites#3
Liberec, , Czechia
Almirall Investigational Sites#2
Lovosice, , Czechia
Almirall Investigational Sites#1
Neratovice, , Czechia
Almirall Investigational Sites#11
Prague, , Czechia
Almirall Investigational Sites#6
Prague, , Czechia
Almirall Investigational Sites#12
Prague, , Czechia
Almirall Investigational Sites#7
Prague, , Czechia
Almirall Investigational Sites#10
Strakonice, , Czechia
Almirall Investigational Sites#3
Clermont-Ferrand, , France
Almirall Investigational Sites#2
Marseille, , France
Almirall Investigational Sites#1
Marseille, , France
Almirall Investigational Sites#6
Montpellier, , France
Almirall Investigational Sites#4
Toulouse, , France
Almirall Investigational Sites#8
Berlin, , Germany
Almirall Investigational Sites#9
Berlin, , Germany
Almirall Investigational Sites#6
Berlin, , Germany
Almirall Investigational Sites#14
Berlin, , Germany
Almirall Investigational Site#7
Berlin, , Germany
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Bonn, , Germany
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Cologne, , Germany
Almirall Investigational Sites#3
Dortmund, , Germany
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Frankfurt, , Germany
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Gelsenkirchen, , Germany
Almirall Investigational Sites#1
Großhansdorf, , Germany
Almirall Investigational Sites#5
Hamburg, , Germany
Almirall Investigational Sites#4
Hamburg, , Germany
Almirall Investigational Site#16
Hanover, , Germany
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Jena, , Germany
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Mainz, , Germany
Almirall Investigational Site#2
Rüdersdorf, , Germany
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Budapest, , Hungary
Almirall Investigational Sites#4
Budapest, , Hungary
Almirall Investigational Sites#1
Budapest, , Hungary
Almirall Investigational Sites#2
Budapest, , Hungary
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Debrecen, , Hungary
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Debrecen, , Hungary
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Deszk, , Hungary
Almirall Investigational Sites#10
Dunaüjváros, , Hungary
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Mátraháza, , Hungary
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Pécs, , Hungary
Almirall Investigational Sites#11
Ráckeve, , Hungary
Almirall Investigational Sites#3
Százhalombatta, , Hungary
Almirall Investigational Sites#8
Zalaegerszeg, , Hungary
Almirall Investigational Sites#3
Cagliari, , Italy
Almirall Investigational Sites#1
Genova, , Italy
Almirall Investigational Sites#10
Pisa, , Italy
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Cusco, , Peru
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Bialystok, , Poland
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Bialystok, , Poland
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Elblag, , Poland
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Gdansk, , Poland
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Iława, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Olsztyn, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Poznan, , Poland
Almirall Investigational Site#11
Proszowice, , Poland
Almirall Investigational Sites#2
Ruda Śląska, , Poland
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Rudka, , Poland
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Sopot, , Poland
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Szczecin, , Poland
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Tarnów, , Poland
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Tarnów, , Poland
Almirall Investigational Sites#25
Warsaw, , Poland
Almirall Investigational Sites#23
Wilkowice-Bystra, , Poland
Almirall Investigational Site#10
Wroclaw, , Poland
Almirall Investigational Sites#5
Kazan', , Russia
Almirall Investigational Sites#2
Moscow, , Russia
Almirall Investigational Sites#14
Moscow, , Russia
Almirall Investigational Sites#6
Moscow, , Russia
Almirall Investigational Sites#13
Novosibirsk, , Russia
Almirall Investigational Sites#10
Saint Petersburg, , Russia
Almirall Investigational Sites#3
Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Tomsk, , Russia
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Tomsk, , Russia
Almirall Investigational Sites#7
Yekaterinburg, , Russia
Almirall Investigational Sites#8
Bloemfontein, , South Africa
Almirall Investigational Sites#11
Bloemfontein, , South Africa
Almirall Investigational Sites#3
Bloemfontein, , South Africa
Almirall Investigational Sites#10
Cape Town, , South Africa
Almirall Investigational Sites#1
Cape Town, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
Almirall Investigational Sites#2
Durban, , South Africa
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George, , South Africa
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Port Elizabeth, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
Almirall Investigational Sites#6
Badalona, , Spain
Almirall Investigational Sites#8
Barcelona, , Spain
Almirall Investigational Sites#7
Barcelona, , Spain
Almirall Investigational Sites#3
Madrid, , Spain
Almirall Investigational Sites#5
Valencia, , Spain
Almirall Investigational Sites#4
Donetsk, , Ukraine
Almirall Investigational Sites#3
Kharkiv, , Ukraine
Almirall Investigational Sites#1
Kyiv, , Ukraine
Almirall Investigational Sites#2
Kyiv, , Ukraine
Almirall Investigational Sites#7
Kyiv, , Ukraine
Almirall Investigational Sites#5
Zaporizhzhya, , Ukraine
Countries
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References
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McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.
Jones PW, Leidy NK, Hareendran A, Lamarca R, Chuecos F, Garcia Gil E. The effect of aclidinium bromide on daily respiratory symptoms of COPD, measured using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) diary: pooled analysis of two 6-month Phase III studies. Respir Res. 2016 May 23;17(1):61. doi: 10.1186/s12931-016-0372-1.
Jones PW, Lamarca R, Chuecos F, Singh D, Agusti A, Bateman ED, de Miquel G, Caracta C, Garcia Gil E. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J. 2014 Nov;44(5):1156-65. doi: 10.1183/09031936.00038814. Epub 2014 Sep 18.
Jones PW, Singh D, Bateman ED, Agusti A, Lamarca R, de Miquel G, Segarra R, Caracta C, Garcia Gil E. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J. 2012 Oct;40(4):830-6. doi: 10.1183/09031936.00225511. Epub 2012 Mar 22.
Related Links
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Almirall Corporate Website
Other Identifiers
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ATTAIN
Identifier Type: -
Identifier Source: secondary_id
M/34273/34
Identifier Type: -
Identifier Source: org_study_id
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