Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT01001494 | Completed Phase 3 Results

• 2 other identifiers: M/34273/34ATTAIN
• Study Type: interventional
• Target: 828
• Locations: 11 countries
• Sites: 106

Brief Summary

The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease; antimuscarinic; COPD

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment

  Baseline and Week 24

• Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment

  Baseline and Week 12

Secondary Outcomes (3)

• Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment

  Baseline and Week 24

• Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment

  Week 24

• Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment

  Week 24

Study Arms (3)

Aclidinium bromide 200 μg bid

EXPERIMENTAL

Aclidinium bromide 200 μg twice-daily via inhalation

Drug: Aclidinium bromide 200 μg bid

Aclidininum bromide 400 μg bid

EXPERIMENTAL

Aclidinium bromide 400 μg twice-daily via inhalation

Drug: Aclidinium bromide 400 μg bid

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Aclidinium bromide 200 μg bid DRUG

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 200 μg bid

Aclidinium bromide 400 μg bid DRUG

Aclidinium bromide 400 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

Placebo DRUG

Placebo twice-daily by inhalation for 24 weeks

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
• Post-salbutamol (FEV1) \< 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC \< 70%.
• Current or ex-smokers of ≥10 pack-years.

You may not qualify if:

• Patients with no history or current diagnosis of asthma.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (106)

Almirall Investigational Sites#4

Benešov, 256 01, Czechia

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Almirall Investigational Sites#9

Jaroměř, 55 101, Czechia

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Almirall Investigational Sites#3

Liberec, 460 01, Czechia

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Almirall Investigational Sites#2

Lovosice, 410 02, Czechia

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Almirall Investigational Sites#1

Neratovice, 277 11, Czechia

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Almirall Investigational Sites#11

Prague, 158 00, Czechia

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Almirall Investigational Sites#6

Prague, 158 00, Czechia

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Almirall Investigational Sites#12

Prague, 163 00, Czechia

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Almirall Investigational Sites#7

Prague, 169 00, Czechia

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Almirall Investigational Sites#10

Strakonice, 386 01, Czechia

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Almirall Investigational Sites#3

Clermont-Ferrand, 63003, France

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Almirall Investigational Sites#2

Marseille, 13008, France

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Almirall Investigational Sites#1

Marseille, 13915, France

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Almirall Investigational Sites#6

Montpellier, 34295, France

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Almirall Investigational Sites#4

Toulouse, 31059, France

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Almirall Investigational Sites#8

Berlin, 10117, Germany

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Almirall Investigational Sites#9

Berlin, 10969, Germany

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Almirall Investigational Sites#6

Berlin, 13125, Germany

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Almirall Investigational Sites#14

Berlin, 13507, Germany

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Almirall Investigational Site#7

Berlin, 14057, Germany

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Almirall Investigational Sites#12

Bonn, 53123, Germany

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Almirall Investigational Sites#10

Cologne, 51069, Germany

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Almirall Investigational Sites#3

Dortmund, 44263, Germany

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Almirall Investigational Sites#13

Frankfurt, 60596, Germany

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Almirall Investigational Sites#15

Gelsenkirchen, 45879, Germany

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Almirall Investigational Sites#1

Großhansdorf, 22927, Germany

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Hamburg, 20249, Germany

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Almirall Investigational Sites#4

Hamburg, 22143, Germany

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Almirall Investigational Site#16

Hanover, 30159, Germany

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Almirall Investigational Sites#18

Jena, 07743, Germany

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Almirall Investigational Sites#11

Mainz, 55131, Germany

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Almirall Investigational Site#2

Rüdersdorf, 15562, Germany

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Almirall Investigational Sites#13

Budapest, 1036, Hungary

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Almirall Investigational Sites#4

Budapest, 1046, Hungary

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Almirall Investigational Sites#1

Budapest, 1125, Hungary

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Budapest, 1529, Hungary

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Debrecen, 4032, Hungary

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Debrecen, 4043, Hungary

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Almirall Investigational Sites#7

Deszk, 6772, Hungary

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Almirall Investigational Sites#10

Dunaüjváros, 2400, Hungary

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Almirall Investigational Sites#9

Mátraháza, 3233, Hungary

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Almirall Investigational Sites#12

Pécs, 7621, Hungary

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Almirall Investigational Sites#11

Ráckeve, 2300, Hungary

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Almirall Investigational Sites#3

Százhalombatta, 2440, Hungary

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Almirall Investigational Sites#8

Zalaegerszeg, 8900, Hungary

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Almirall Investigational Sites#3

Cagliari, 09126, Italy

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Almirall Investigational Sites#1

Genova, 16132, Italy

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Almirall Investigational Sites#10

Pisa, 56124, Italy

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Almirall Investigational Sites#8

Cusco, Peru

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Almirall Investigational Sites#12

Bialystok, 15-003, Poland

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Almirall Investigational Sites#9

Bialystok, 15-540, Poland

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Almirall Investigational Sites#19

Elblag, 82-307, Poland

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Almirall Investigational Sites#18

Gdansk, 80-211, Poland

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Almirall Investigational Sites#20

Iława, 14-200, Poland

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Almirall Investigational Sites#7

Lodz, 90-430, Poland

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Almirall Investigational Sites#1

Lodz, 91-153, Poland

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Almirall Investigational Sites#8

Lublin, Poland

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Almirall Investigational Sites#24

Olsztyn, 10-357, Poland

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Almirall Investigational Sites#5

Olsztyn, 10-357, Poland

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Almirall Investigational Sites#21

Poznan, 60-214, Poland

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Almirall Investigational Sites#16

Poznan, 60-693, Poland

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Almirall Investigational Site#11

Proszowice, 32-100, Poland

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Almirall Investigational Sites#2

Ruda Śląska, 41-709, Poland

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Almirall Investigational Sites#13

Rudka, 05-320, Poland

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Sopot, 81-741, Poland

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Almirall Investigational Sites#14

Szczecin, 70-111, Poland

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Tarnów, 33-100, Poland

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Almirall Investigational Sites#6

Tarnów, 33-100, Poland

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Almirall Investigational Sites#25

Warsaw, 01-138, Poland

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Almirall Investigational Sites#23

Wilkowice-Bystra, 43-365, Poland

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Almirall Investigational Site#10

Wroclaw, 50-349, Poland

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Almirall Investigational Sites#5

Kazan', 420015/420103, Russia

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Almirall Investigational Sites#2

Moscow, 115446, Russia

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Almirall Investigational Sites#14

Moscow, 123182, Russia

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Almirall Investigational Sites#6

Moscow, 127018/127473, Russia

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Almirall Investigational Sites#13

Novosibirsk, 630008, Russia

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Almirall Investigational Sites#10

Saint Petersburg, 194354, Russia

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Almirall Investigational Sites#3

Saint Petersburg, 197022, Russia

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Almirall Investigational Sites#4

Saint Petersburg, 197089/197022, Russia

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Almirall Investigational Sites#8

Tomsk, 634050/634034, Russia

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Almirall Investigational Sites#12

Tomsk, 634050, Russia

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Almirall Investigational Sites#7

Yekaterinburg, 620219 / 620109, Russia

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Almirall Investigational Sites#8

Bloemfontein, 9300, South Africa

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Almirall Investigational Sites#11

Bloemfontein, 9301, South Africa

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Almirall Investigational Sites#3

Bloemfontein, 9301, South Africa

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Almirall Investigational Sites#10

Cape Town, 7500, South Africa

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Almirall Investigational Sites#1

Cape Town, 7505, South Africa

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Almirall Investigational Sites#12

Cape Town, South Africa

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Almirall Investigational Sites#15

Cape Town, South Africa

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Almirall Investigational Sites#2

Durban, South Africa

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Almirall Investigational Sites#9

George, 6529, South Africa

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Almirall Investigational Sites#4

Port Elizabeth, 6045, South Africa

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Almirall Investigational Sites#5

Pretoria, 0002, South Africa

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Almirall Investigational Sites#14

Pretoria, 0081, South Africa

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Almirall Investigational Sites#6

Pretoria, 181, South Africa

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Almirall Investigational Sites#6

Badalona, 08916, Spain

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Almirall Investigational Sites#8

Barcelona, 08035, Spain

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Almirall Investigational Sites#7

Barcelona, 08036, Spain

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Almirall Investigational Sites#3

Madrid, 28041, Spain

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Almirall Investigational Sites#5

Valencia, 46015, Spain

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Almirall Investigational Sites#4

Donetsk, 83099, Ukraine

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Almirall Investigational Sites#3

Kharkiv, 61001, Ukraine

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Almirall Investigational Sites#1

Kyiv, 03680, Ukraine

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Almirall Investigational Sites#2

Kyiv, 03680, Ukraine

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Almirall Investigational Sites#7

Kyiv, 04050, Ukraine

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Almirall Investigational Sites#5

Zaporizhzhya, 69118, Ukraine

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Related Publications (4)

• 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.

  PMID: 28074135 DERIVED

• 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.

  PMID: 27215749 DERIVED

• 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.

  PMID: 25234803 DERIVED

• 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.

  PMID: 22441743 DERIVED

Related Links

• Almirall Corporate Website

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

aclidinium bromide; BID protein, human

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: AstraZeneca Clinical
• Organization: Study Information Center

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Esther Garcia, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 26, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 4, 2017
• Results First Posted: September 17, 2012

Record last verified: 2016-10

Locations

ES (5); UA (6); ZA (13); HU (13); CZ (10); FR (5); IT (3); PE (1); PL (22); RU (11); DE (17)