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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT00363896
First received: August 10, 2006
Last updated: February 13, 2013
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Aclidinium bromide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

Resource links provided by NLM:


Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:
  • Trough FEV1 (L) at 28 Weeks on Treatment [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
    Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks

  • Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks


Secondary Outcome Measures:
  • Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 843
Study Start Date: August 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aclidinium 200 μg once-daily
Aclidinium bromide 200 μg once-daily by inhalation
Drug: Aclidinium bromide
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
Drug: Placebo
Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363896

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

Additional Information:
No publications provided by Almirall, S.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT00363896     History of Changes
Other Study ID Numbers: CT000740, ACCLAIM I, M/34273/30
Study First Received: August 10, 2006
Results First Received: August 14, 2012
Last Updated: February 13, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Almirall, S.A.:
COPD
Lung function
Exacerbations
Quality of Life

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014