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

November 16, 2016 updated by: AstraZeneca

Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

843

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Escaldes, Andorra
        • Almirall Investigational Sites#947
      • Graz, Austria, 8036
        • Almirall Investigational Sites#645
      • Innsbruck, Austria, 6020
        • Almirall Investigational Sites#646
      • Linz, Austria, 4010
        • Almirall Investigational Sites#644
      • Wien, Austria, 1090
        • Almirall Investigational Sites#647
      • Wien, Austria, 1145
        • Almirall Investigational Sites#649
      • Aalst, Belgium, 9300
        • Almirall Investigational Sites#110
      • Brussels, Belgium, 1090
        • Almirall Investigational Sites#394
      • Edegem, Belgium, 2650
        • Almirall Investigational Sites#651
      • Namur, Belgium, 5000
        • Almirall Investigational Sites#393
      • Burgas, Bulgaria, 800
        • Almirall Investigational Sites#658
      • Pleven, Bulgaria, 5800
        • Almirall Investigational Sites#653
      • Plovdiv, Bulgaria, 4000
        • Almirall Investigational Sites#654
      • Russe, Bulgaria, 7000
        • Almirall Investigational Sites#656
      • Sofia, Bulgaria, 1431
        • Almirall Investigational Sites#652
      • Sofia, Bulgaria, 1431
        • Almirall Investigational Sites#657
      • Sofia, Bulgaria, 1431
        • Almirall Investigational Sites#972
      • Sofia, Bulgaria, 1618
        • Almirall Investigational Sites#971
      • Varna, Bulgaria, 9010
        • Almirall Investigational Sites#655
      • Veliko Tarnovo, Bulgaria, 5000
        • Almirall Investigational Sites#953
      • Lovosice, Czech Republic, 410 02
        • Almirall Investigational Sites#664
      • Neratovice, Czech Republic, 277 11
        • Almirall Investigational Sites#660
      • Plzen, Czech Republic, 324 01
        • Almirall Investigational Sites#662
      • Prague, Czech Republic, 169 02
        • Almirall Investigational Sites#666
      • Praha, Czech Republic, 182 00
        • Almirall Investigational Sites#661
      • Tabor, Czech Republic, 390 03
        • Almirall Investigational Sites#665
      • Tremosna, Czech Republic, 330 11
        • Almirall Investigational Sites#659
      • Zatec, Czech Republic, 43801
        • Almirall Investigational Sites#954
      • Aalborg, Denmark, 9100
        • Almirall Investigational Sites#398
      • Odense C., Denmark, 5000
        • Almirall Investigational Sites#397
      • Århus C, Denmark, 8000
        • Almirall Investigational Sites#390
      • Beuvry, France, 62660
        • Almirall Investigational Sites#594
      • Brest Cedex, France, 29609
        • Almirall Investigational Sites#593
      • Grasse, France, 06130
        • Almirall Investigational Sites#750
      • Montpellier,cedex 5, France, 34295
        • Almirall Investigational Sites#669
      • Paris, France, 75004
        • Almirall Investigational Sites#672
      • Perpignan Cedex, France, 66025
        • Almirall Investigational Sites#948
      • Rouen , Cedex, France, 76031
        • Almirall Investigational Sites#549
      • Strasbourg Cedex, France, 67098
        • Almirall Investigational Sites#671
      • Vieux Conde, France, 59690
        • Almirall Investigational Sites#752
      • Bad Wörishofen, Germany, 86825
        • Almirall Investigational Sites#678
      • Berlin, Germany, 10717
        • Almirall Investigational Sites#758
      • Berlin, Germany, 10969
        • Almirall Investigational Sites#765
      • Berlin, Germany, 13125
        • Almirall Investigational Sites#680
      • Berlin-Spandau, Germany, 13597
        • Almirall Investigational Sites#677
      • Bonn, Germany, 53123
        • Almirall Investigational Sites#681
      • Grosshansdorf, Germany, 22927
        • Almirall Investigational Sites#191
      • Hamburg, Germany, 20249
        • Almirall Investigational Sites#766
      • Jena, Germany, 07743
        • Almirall Investigational Sites#757
      • Mainz, Germany, 55131
        • Almirall Investigational Sites#675
      • Budapest, Hungary, 1117
        • Almirall Investigational Sites#684
      • Debrecen, Hungary, 4012
        • Almirall Investigational Sites#687
      • Debrecen, Hungary, 4043
        • Almirall Investigational Sites#683
      • Nyiregyhaza, Hungary, 4412
        • Almirall Investigational Sites#688
      • Szekesfehervar, Hungary, 8000
        • Almirall Investigational Sites#686
      • Szombathely, Hungary, 9700
        • Almirall Investigational Sites#689
      • Tatabanya, Hungary, 2800
        • Almirall Investigational Sites#682
      • Torokbalint, Hungary, 2045
        • Almirall Investigational Sites#685
      • Genova, Italy, 16132
        • Almirall Investigational Sites#459
      • Milano, Italy, 20142
        • Almirall Investigational Sites#774
      • Modena, Italy, 41100
        • Almirall Investigational Sites#286
      • Napoli, Italy, 80131
        • Almirall Investigational Sites#694
      • Perugia, Italy, 06156
        • Almirall Investigational Sites#635
      • Pordenone, Italy, 33170
        • Almirall Investigational Sites#777
      • Breda, Netherlands, 4819 EV
        • Almirall Investigational Sites#346
      • Eindhoven, Netherlands, 5623 EJ
        • Almirall Investigational Sites#551
      • Hengelo, Netherlands, 7555 DL
        • Almirall Investigational Sites#348
      • Hoofddorp, Netherlands, 2134TM
        • Almirall Investigational Sites#695
      • Lodz, Poland, 90-430
        • Almirall Investigational Sites#700
      • Lodz, Poland, 91-520
        • Almirall Investigational Sites#698
      • Torun, Poland, 87-100
        • Almirall Investigational Sites#697
      • Warszawa, Poland, 01-138
        • Almirall Investigational Sites#699
      • Warszawa, Poland, 01-337
        • Almirall Investigational Sites#696
      • Warszawa, Poland, 03-416
        • Almirall Investigational Sites#702
      • Wroclaw, Poland, 50-434
        • Almirall Investigational Sites#706
      • Zabrze, Poland, 41-800
        • Almirall Investigational Sites#705
      • Zawadzkie, Poland, 47-120
        • Almirall Investigational Sites#701
      • Brasov, Romania, 500326
        • Almirall Investigational Sites#962
      • Bucharest, Romania, 21659
        • Almirall Investigational Sites#714
      • Bucuresti, Romania, 0100825
        • Almirall Investigational Sites#970
      • Cluj-Napoca, Romania, 400371
        • Almirall Investigational Sites#713
      • Iasi, Romania, 700115
        • Almirall Investigational Sites#712
      • Judetul Brasov, Romania, 500365
        • Almirall Investigational Sites#961
      • Palazu Mare, Romania, 900002
        • Almirall Investigational Sites#709
      • Targu Mures, Romania, 540139
        • Almirall Investigational Sites#711
      • Timisoara, Romania, 1900
        • Almirall Investigational Sites#715
      • Moscow, Russian Federation, 105077
        • Almirall Investigational Sites#462
      • Moscow, Russian Federation, 105077
        • Almirall Investigational Sites#977
      • Moscow, Russian Federation, 105229
        • Almirall Investigational Sites#721
      • Moscow, Russian Federation, 109240
        • Almirall Investigational Sites#540
      • Moscow, Russian Federation, 115446
        • Almirall Investigational Sites#967
      • Moscow, Russian Federation, 117485
        • Almirall Investigational Sites#716
      • Moscow, Russian Federation, 119048
        • Almirall Investigational Sites#722
      • Moscow, Russian Federation, 121359
        • Almirall Investigational Sites#719
      • Moscow, Russian Federation, 123182
        • Almirall Investigational Sites#582
      • Moscow, Russian Federation, 123182
        • Almirall Investigational Sites#785
      • Moscow, Russian Federation, 127018
        • Almirall Investigational Sites#976
      • Moscow region, Russian Federation, 143405
        • Almirall Investigational Sites#717
      • Saint Petersburg, Russian Federation, 193231
        • Almirall Investigational Sites#588
      • Saint Petersburg, Russian Federation, 193312
        • Almirall Investigational Sites#720
      • Saint Petersburg, Russian Federation, 193312
        • Almirall Investigational Sites#965
      • Saint Petersburg, Russian Federation, 194291
        • Almirall Investigational Sites#543
      • Saint Petersburg, Russian Federation, 194354
        • Almirall Investigational Sites#787
      • Saint Petersburg, Russian Federation, 195067
        • Almirall Investigational Sites#975
      • Saint Petersburg, Russian Federation, 196247
        • Almirall Investigational Sites#465
      • Saint Petersburg, Russian Federation, 196247
        • Almirall Investigational Sites#966
      • Saint Petersburg, Russian Federation, 197022
        • Almirall Investigational Sites#972
      • Saint Petersburg, Russian Federation, 197089
        • Almirall Investigational Sites#786
      • Saint Petersburg, Russian Federation, 198216
        • Almirall Investigational Sites#963
      • Sochi, Russian Federation, 354057
        • Almirall Investigational Sites#718
      • saint Petersburg, Russian Federation, 194044
        • Almirall Investigational Sites#969
      • Badalona, Spain, 08916
        • Almirall Investigational Sites#16
      • Barcelona, Spain, 08035
        • Almirall Investigational Sites#7
      • Barcelona, Spain, 08036
        • Almirall Investigational Sites#317
      • Madrid, Spain, 28006
        • Almirall Investigational Sites#61
      • Málaga, Spain, 29010
        • Almirall Investigational Sites#938
      • Palma de Mallorca, Spain, 07014
        • Almirall Investigational Sites#727
      • San Juan de Alicante, Spain, 03550
        • Almirall Investigational Sites#723
      • Terrassa, Spain, 08221
        • Almirall Investigational Sites#725
      • Bedford, United Kingdom, MK42 9DJ
        • Almirall Investigational Sites#738
      • Bristol, United Kingdom, BS2 8HW
        • Almirall Investigational Sites#42
      • Cottingham, United Kingdom, HU16 5JQ
        • Almirall Investigational Sites#734
      • Doncaster, United Kingdom, DN2 5LT
        • Almirall Investigational Sites#735
      • Exeter, United Kingdom, EX2 5DW
        • Almirall Investigational Sites#788
      • Hereford, United Kingdom, HR1 2ER
        • Almirall Investigational Sites#737
      • London, United Kingdom, E2 9JX
        • Almirall Investigational Sites#784
      • London, United Kingdom, SW17 0RE
        • Almirall Investigational Sites#37
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Almirall Investigational Sites#730
      • Peterborough, United Kingdom, PE3 6DA
        • Almirall Investigational Sites#731
      • Solihull, United Kingdom, B91 2JL
        • Almirall Investigational Sites#728
      • Suffolk, United Kingdom, IP33 2QZ
        • Almirall Investigational Sites#732
      • Windsor, United Kingdom, SL4 3DP
        • Almirall Investigational Sites#736

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aclidinium 200 μg once-daily
Aclidinium bromide 200 μg once-daily by inhalation
Aclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks
Placebo Comparator: Placebo
Placebo once-daily via inhalation
Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough FEV1 (L) at 28 Weeks on Treatment
Time Frame: Week 28
Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks
Week 28
Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment
Time Frame: Week 12
Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment
Time Frame: Week 52

Time to first moderate or severe exacerbation:

Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.

Week 52
Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment
Time Frame: 52 weeks
Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

August 10, 2006

First Submitted That Met QC Criteria

August 14, 2006

First Posted (Estimate)

August 15, 2006

Study Record Updates

Last Update Posted (Estimate)

January 6, 2017

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • M/34273/30
  • ACCLAIM I (Other Identifier: Almirall,S.A.)
  • CT000740 (Other Identifier: Almirall,S.A.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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