MedDataX Logo

A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00363896

Last Updated: 2017-01-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

843 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)

NCT00358436

Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED PHASE3

Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT00435760

Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED PHASE3

Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)

NCT01045161

Chronic Obstructive Pulmonary Disease
COMPLETED PHASE3

Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)

NCT00891462

Chronic Obstructive Pulmonary Disease
COMPLETED PHASE3

BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH

NCT02375724

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aclidinium 200 μg once-daily

Aclidinium bromide 200 μg once-daily by inhalation

Group Type EXPERIMENTAL

Aclidinium bromide

Intervention Type DRUG

Aclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks

Placebo

Placebo once-daily via inhalation

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aclidinium bromide

Aclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks

Intervention Type DRUG

Placebo

Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria

* History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Esther Garcia, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Almirall Investigational Sites#947

Les Escaldes, , Andorra

Site Status

Almirall Investigational Sites#645

Graz, , Austria

Site Status

Almirall Investigational Sites#646

Innsbruck, , Austria

Site Status

Almirall Investigational Sites#644

Linz, , Austria

Site Status

Almirall Investigational Sites#647

Vienna, , Austria

Site Status

Almirall Investigational Sites#649

Vienna, , Austria

Site Status

Almirall Investigational Sites#110

Aalst, , Belgium

Site Status

Almirall Investigational Sites#394

Brussels, , Belgium

Site Status

Almirall Investigational Sites#651

Edegem, , Belgium

Site Status

Almirall Investigational Sites#393

Namur, , Belgium

Site Status

Almirall Investigational Sites#658

Burgas, , Bulgaria

Site Status

Almirall Investigational Sites#653

Pleven, , Bulgaria

Site Status

Almirall Investigational Sites#654

Plovdiv, , Bulgaria

Site Status

Almirall Investigational Sites#656

Rousse, , Bulgaria

Site Status

Almirall Investigational Sites#652

Sofia, , Bulgaria

Site Status

Almirall Investigational Sites#657

Sofia, , Bulgaria

Site Status

Almirall Investigational Sites#972

Sofia, , Bulgaria

Site Status

Almirall Investigational Sites#971

Sofia, , Bulgaria

Site Status

Almirall Investigational Sites#655

Varna, , Bulgaria

Site Status

Almirall Investigational Sites#953

Veliko Tarnovo, , Bulgaria

Site Status

Almirall Investigational Sites#664

Lovosice, , Czechia

Site Status

Almirall Investigational Sites#660

Neratovice, , Czechia

Site Status

Almirall Investigational Sites#662

Pilsen, , Czechia

Site Status

Almirall Investigational Sites#666

Prague, , Czechia

Site Status

Almirall Investigational Sites#661

Prague, , Czechia

Site Status

Almirall Investigational Sites#665

Tábor, , Czechia

Site Status

Almirall Investigational Sites#659

Třemošná, , Czechia

Site Status

Almirall Investigational Sites#954

Žatec, , Czechia

Site Status

Almirall Investigational Sites#398

Aalborg, , Denmark

Site Status

Almirall Investigational Sites#390

Århus C, , Denmark

Site Status

Almirall Investigational Sites#397

Odense C, , Denmark

Site Status

Almirall Investigational Sites#594

Beuvry, , France

Site Status

Almirall Investigational Sites#593

Brest, , France

Site Status

Almirall Investigational Sites#750

Grasse, , France

Site Status

Almirall Investigational Sites#669

Montpellier, , France

Site Status

Almirall Investigational Sites#672

Paris, , France

Site Status

Almirall Investigational Sites#948

Perpignan, , France

Site Status

Almirall Investigational Sites#549

Rouen, , France

Site Status

Almirall Investigational Sites#671

Strasbourg, , France

Site Status

Almirall Investigational Sites#752

Vieux-Condé, , France

Site Status

Almirall Investigational Sites#678

Bad Wörishofen, , Germany

Site Status

Almirall Investigational Sites#758

Berlin, , Germany

Site Status

Almirall Investigational Sites#765

Berlin, , Germany

Site Status

Almirall Investigational Sites#680

Berlin, , Germany

Site Status

Almirall Investigational Sites#677

Berlin-Spandau, , Germany

Site Status

Almirall Investigational Sites#681

Bonn, , Germany

Site Status

Almirall Investigational Sites#191

Großhansdorf, , Germany

Site Status

Almirall Investigational Sites#766

Hamburg, , Germany

Site Status

Almirall Investigational Sites#757

Jena, , Germany

Site Status

Almirall Investigational Sites#675

Mainz, , Germany

Site Status

Almirall Investigational Sites#684

Budapest, , Hungary

Site Status

Almirall Investigational Sites#687

Debrecen, , Hungary

Site Status

Almirall Investigational Sites#683

Debrecen, , Hungary

Site Status

Almirall Investigational Sites#688

Nyíregyháza, , Hungary

Site Status

Almirall Investigational Sites#686

Székesfehérvár, , Hungary

Site Status

Almirall Investigational Sites#689

Szombathely, , Hungary

Site Status

Almirall Investigational Sites#682

Tatabánya, , Hungary

Site Status

Almirall Investigational Sites#685

Törökbálint, , Hungary

Site Status

Almirall Investigational Sites#459

Genova, , Italy

Site Status

Almirall Investigational Sites#774

Milan, , Italy

Site Status

Almirall Investigational Sites#286

Modena, , Italy

Site Status

Almirall Investigational Sites#694

Napoli, , Italy

Site Status

Almirall Investigational Sites#635

Perugia, , Italy

Site Status

Almirall Investigational Sites#777

Pordenone, , Italy

Site Status

Almirall Investigational Sites#346

Breda, , Netherlands

Site Status

Almirall Investigational Sites#551

Eindhoven, , Netherlands

Site Status

Almirall Investigational Sites#348

Hengelo, , Netherlands

Site Status

Almirall Investigational Sites#695

Hoofddorp, , Netherlands

Site Status

Almirall Investigational Sites#700

Lodz, , Poland

Site Status

Almirall Investigational Sites#698

Lodz, , Poland

Site Status

Almirall Investigational Sites#697

Torun, , Poland

Site Status

Almirall Investigational Sites#699

Warsaw, , Poland

Site Status

Almirall Investigational Sites#696

Warsaw, , Poland

Site Status

Almirall Investigational Sites#702

Warsaw, , Poland

Site Status

Almirall Investigational Sites#706

Wroclaw, , Poland

Site Status

Almirall Investigational Sites#705

Zabrze, , Poland

Site Status

Almirall Investigational Sites#701

Zawadzkie, , Poland

Site Status

Almirall Investigational Sites#962

Brasov, , Romania

Site Status

Almirall Investigational Sites#970

Bucharest, , Romania

Site Status

Almirall Investigational Sites#714

Bucharest, , Romania

Site Status

Almirall Investigational Sites#713

Cluj-Napoca, , Romania

Site Status

Almirall Investigational Sites#712

Iași, , Romania

Site Status

Almirall Investigational Sites#961

Judetul Brasov, , Romania

Site Status

Almirall Investigational Sites#709

Palazu Mare, , Romania

Site Status

Almirall Investigational Sites#711

Târgu Mureş, , Romania

Site Status

Almirall Investigational Sites#715

Timișoara, , Romania

Site Status

Almirall Investigational Sites#462

Moscow, , Russia

Site Status

Almirall Investigational Sites#977

Moscow, , Russia

Site Status

Almirall Investigational Sites#721

Moscow, , Russia

Site Status

Almirall Investigational Sites#540

Moscow, , Russia

Site Status

Almirall Investigational Sites#967

Moscow, , Russia

Site Status

Almirall Investigational Sites#716

Moscow, , Russia

Site Status

Almirall Investigational Sites#722

Moscow, , Russia

Site Status

Almirall Investigational Sites#719

Moscow, , Russia

Site Status

Almirall Investigational Sites#582

Moscow, , Russia

Site Status

Almirall Investigational Sites#785

Moscow, , Russia

Site Status

Almirall Investigational Sites#976

Moscow, , Russia

Site Status

Almirall Investigational Sites#717

Moscow Region, , Russia

Site Status

Almirall Investigational Sites#588

Saint Petersburg, , Russia

Site Status

Almirall Investigational Sites#720

Saint Petersburg, , Russia

Site Status

Almirall Investigational Sites#965

Saint Petersburg, , Russia

Site Status

Almirall Investigational Sites#969

Saint Petersburg, , Russia

Site Status

Almirall Investigational Sites#543

Saint Petersburg, , Russia

Site Status

Almirall Investigational Sites#787

Saint Petersburg, , Russia

Site Status

Almirall Investigational Sites#975

Saint Petersburg, , Russia

Site Status

Almirall Investigational Sites#465

Saint Petersburg, , Russia

Site Status

Almirall Investigational Sites#966

Saint Petersburg, , Russia

Site Status

Almirall Investigational Sites#972

Saint Petersburg, , Russia

Site Status

Almirall Investigational Sites#786

Saint Petersburg, , Russia

Site Status

Almirall Investigational Sites#963

Saint Petersburg, , Russia

Site Status

Almirall Investigational Sites#718

Sochi, , Russia

Site Status

Almirall Investigational Sites#16

Badalona, , Spain

Site Status

Almirall Investigational Sites#7

Barcelona, , Spain

Site Status

Almirall Investigational Sites#317

Barcelona, , Spain

Site Status

Almirall Investigational Sites#61

Madrid, , Spain

Site Status

Almirall Investigational Sites#938

Málaga, , Spain

Site Status

Almirall Investigational Sites#727

Palma de Mallorca, , Spain

Site Status

Almirall Investigational Sites#723

Sant Joan d'Alacant, , Spain

Site Status

Almirall Investigational Sites#725

Terrassa, , Spain

Site Status

Almirall Investigational Sites#738

Bedford, , United Kingdom

Site Status

Almirall Investigational Sites#42

Bristol, , United Kingdom

Site Status

Almirall Investigational Sites#734

Cottingham, , United Kingdom

Site Status

Almirall Investigational Sites#735

Doncaster, , United Kingdom

Site Status

Almirall Investigational Sites#788

Exeter, , United Kingdom

Site Status

Almirall Investigational Sites#737

Hereford, , United Kingdom

Site Status

Almirall Investigational Sites#784

London, , United Kingdom

Site Status

Almirall Investigational Sites#37

London, , United Kingdom

Site Status

Almirall Investigational Sites#730

Newcastle upon Tyne, , United Kingdom

Site Status

Almirall Investigational Sites#731

Peterborough, , United Kingdom

Site Status

Almirall Investigational Sites#728

Solihull, , United Kingdom

Site Status

Almirall Investigational Sites#732

Suffolk, , United Kingdom

Site Status

Almirall Investigational Sites#736

Windsor, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Andorra Austria Belgium Bulgaria Czechia Denmark France Germany Hungary Italy Netherlands Poland Romania Russia Spain United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Jones PW, Rennard SI, Agusti A, Chanez P, Magnussen H, Fabbri L, Donohue JF, Bateman ED, Gross NJ, Lamarca R, Caracta C, Gil EG. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respir Res. 2011 Apr 26;12(1):55. doi: 10.1186/1465-9921-12-55.

Reference Type DERIVED
PMID: 21518460 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.almirall.com/webcorp2/cda/ImD_04_02.jsp

Sponsor web site

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4056&filename=Synopsis_m-34273-30.pdf

CSR Synopsis

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ACCLAIM I

Identifier Type: OTHER

Identifier Source: secondary_id

CT000740

Identifier Type: OTHER

Identifier Source: secondary_id

M/34273/30

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)
NCT00970268 COMPLETED PHASE3
A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00500318 COMPLETED PHASE3
Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT01001494 COMPLETED PHASE3
Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)
NCT01044459 COMPLETED PHASE3
Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.
NCT01120093 COMPLETED PHASE2
Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population
NCT01425814 COMPLETED PHASE2
The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01205269 COMPLETED PHASE2
A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00758706 COMPLETED PHASE2
AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD)
NCT01215279 COMPLETED PHASE2
Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination
NCT01462942 COMPLETED PHASE3
Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00758459 COMPLETED PHASE2
Two-part Pharmacokinetic and Pharmacodynamic Study of LAS190792 in Patients With Asthma and COPD
NCT02059434 COMPLETED PHASE1
Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00690482 COMPLETED PHASE2
A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients
NCT01498081 COMPLETED PHASE2
A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT01708057 TERMINATED PHASE2
Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01908140 COMPLETED PHASE3
Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01471171 COMPLETED PHASE3
Effect of Aclidinium/Formoterol on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe COPD Patients
NCT02424344 COMPLETED PHASE4
Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01462929 COMPLETED PHASE3
Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT01437540 COMPLETED PHASE3
Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00629239 COMPLETED PHASE2
A Phase IIa Study to Investigate the Efficacy and Safety of AZD7624 in Chronic Obstructive Pulmonary Disease (COPD) Patients While on Maintenance Therapy
NCT02238483 COMPLETED PHASE2
Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00868231 COMPLETED PHASE2
A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00703391 COMPLETED PHASE2
Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01437397 COMPLETED PHASE3