A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
3 other identifiers
interventional
843
16 countries
132
Brief Summary
To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2006
132 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 10, 2006
CompletedFirst Posted
Study publicly available on registry
August 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
November 1, 2012
CompletedJanuary 6, 2017
November 1, 2016
1.8 years
August 10, 2006
August 14, 2012
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Trough FEV1 (L) at 28 Weeks on Treatment
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
Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks
Week 12
Secondary Outcomes (2)
Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment
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
52 weeks
Study Arms (2)
Aclidinium 200 μg once-daily
EXPERIMENTALAclidinium bromide 200 μg once-daily by inhalation
Placebo
PLACEBO COMPARATORPlacebo once-daily via inhalation
Interventions
Aclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks
Eligibility Criteria
You may qualify if:
- Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (132)
Almirall Investigational Sites#947
Les Escaldes, Andorra
Almirall Investigational Sites#645
Graz, 8036, Austria
Almirall Investigational Sites#646
Innsbruck, 6020, Austria
Almirall Investigational Sites#644
Linz, 4010, Austria
Almirall Investigational Sites#647
Vienna, 1090, Austria
Almirall Investigational Sites#649
Vienna, 1145, Austria
Almirall Investigational Sites#110
Aalst, 9300, Belgium
Almirall Investigational Sites#394
Brussels, 1090, Belgium
Almirall Investigational Sites#651
Edegem, 2650, Belgium
Almirall Investigational Sites#393
Namur, 5000, Belgium
Almirall Investigational Sites#658
Burgas, 800, Bulgaria
Almirall Investigational Sites#653
Pleven, 5800, Bulgaria
Almirall Investigational Sites#654
Plovdiv, 4000, Bulgaria
Almirall Investigational Sites#656
Rousse, 7000, Bulgaria
Almirall Investigational Sites#652
Sofia, 1431, Bulgaria
Almirall Investigational Sites#657
Sofia, 1431, Bulgaria
Almirall Investigational Sites#972
Sofia, 1431, Bulgaria
Almirall Investigational Sites#971
Sofia, 1618, Bulgaria
Almirall Investigational Sites#655
Varna, 9010, Bulgaria
Almirall Investigational Sites#953
Veliko Tarnovo, 5000, Bulgaria
Almirall Investigational Sites#664
Lovosice, 410 02, Czechia
Almirall Investigational Sites#660
Neratovice, 277 11, Czechia
Almirall Investigational Sites#662
Pilsen, 324 01, Czechia
Almirall Investigational Sites#666
Prague, 169 02, Czechia
Almirall Investigational Sites#661
Prague, 182 00, Czechia
Almirall Investigational Sites#665
Tábor, 390 03, Czechia
Almirall Investigational Sites#659
Třemošná, 330 11, Czechia
Almirall Investigational Sites#954
Žatec, 43801, Czechia
Almirall Investigational Sites#398
Aalborg, 9100, Denmark
Almirall Investigational Sites#390
Ã…rhus C, 8000, Denmark
Almirall Investigational Sites#397
Odense C, 5000, Denmark
Almirall Investigational Sites#594
Beuvry, 62660, France
Almirall Investigational Sites#593
Brest, 29609, France
Almirall Investigational Sites#750
Grasse, 06130, France
Almirall Investigational Sites#669
Montpellier, 34295, France
Almirall Investigational Sites#672
Paris, 75004, France
Almirall Investigational Sites#948
Perpignan, 66025, France
Almirall Investigational Sites#549
Rouen, 76031, France
Almirall Investigational Sites#671
Strasbourg, 67098, France
Almirall Investigational Sites#752
Vieux-Condé, 59690, France
Almirall Investigational Sites#678
Bad Wörishofen, 86825, Germany
Almirall Investigational Sites#758
Berlin, 10717, Germany
Almirall Investigational Sites#765
Berlin, 10969, Germany
Almirall Investigational Sites#680
Berlin, 13125, Germany
Almirall Investigational Sites#677
Berlin-Spandau, 13597, Germany
Almirall Investigational Sites#681
Bonn, 53123, Germany
Almirall Investigational Sites#191
Großhansdorf, 22927, Germany
Almirall Investigational Sites#766
Hamburg, 20249, Germany
Almirall Investigational Sites#757
Jena, 07743, Germany
Almirall Investigational Sites#675
Mainz, 55131, Germany
Almirall Investigational Sites#684
Budapest, 1117, Hungary
Almirall Investigational Sites#687
Debrecen, 4012, Hungary
Almirall Investigational Sites#683
Debrecen, 4043, Hungary
Almirall Investigational Sites#688
NyÃregyháza, 4412, Hungary
Almirall Investigational Sites#686
Székesfehérvár, 8000, Hungary
Almirall Investigational Sites#689
Szombathely, 9700, Hungary
Almirall Investigational Sites#682
Tatabánya, 2800, Hungary
Almirall Investigational Sites#685
Törökbálint, 2045, Hungary
Almirall Investigational Sites#459
Genova, 16132, Italy
Almirall Investigational Sites#774
Milan, 20142, Italy
Almirall Investigational Sites#286
Modena, 41100, Italy
Almirall Investigational Sites#694
Napoli, 80131, Italy
Almirall Investigational Sites#635
Perugia, 06156, Italy
Almirall Investigational Sites#777
Pordenone, 33170, Italy
Almirall Investigational Sites#346
Breda, 4819 EV, Netherlands
Almirall Investigational Sites#551
Eindhoven, 5623 EJ, Netherlands
Almirall Investigational Sites#348
Hengelo, 7555 DL, Netherlands
Almirall Investigational Sites#695
Hoofddorp, 2134TM, Netherlands
Almirall Investigational Sites#700
Lodz, 90-430, Poland
Almirall Investigational Sites#698
Lodz, 91-520, Poland
Almirall Investigational Sites#697
Torun, 87-100, Poland
Almirall Investigational Sites#699
Warsaw, 01-138, Poland
Almirall Investigational Sites#696
Warsaw, 01-337, Poland
Almirall Investigational Sites#702
Warsaw, 03-416, Poland
Almirall Investigational Sites#706
Wroclaw, 50-434, Poland
Almirall Investigational Sites#705
Zabrze, 41-800, Poland
Almirall Investigational Sites#701
Zawadzkie, 47-120, Poland
Almirall Investigational Sites#962
Brasov, 500326, Romania
Almirall Investigational Sites#970
Bucharest, 0100825, Romania
Almirall Investigational Sites#714
Bucharest, 21659, Romania
Almirall Investigational Sites#713
Cluj-Napoca, 400371, Romania
Almirall Investigational Sites#712
Iași, 700115, Romania
Almirall Investigational Sites#961
Judetul Brasov, 500365, Romania
Almirall Investigational Sites#709
Palazu Mare, 900002, Romania
Almirall Investigational Sites#711
Târgu Mureş, 540139, Romania
Almirall Investigational Sites#715
Timișoara, 1900, Romania
Almirall Investigational Sites#462
Moscow, 105077, Russia
Almirall Investigational Sites#977
Moscow, 105077, Russia
Almirall Investigational Sites#721
Moscow, 105229, Russia
Almirall Investigational Sites#540
Moscow, 109240, Russia
Almirall Investigational Sites#967
Moscow, 115446, Russia
Almirall Investigational Sites#716
Moscow, 117485, Russia
Almirall Investigational Sites#722
Moscow, 119048, Russia
Almirall Investigational Sites#719
Moscow, 121359, Russia
Almirall Investigational Sites#582
Moscow, 123182, Russia
Almirall Investigational Sites#785
Moscow, 123182, Russia
Almirall Investigational Sites#976
Moscow, 127018, Russia
Almirall Investigational Sites#717
Moscow Region, 143405, Russia
Almirall Investigational Sites#588
Saint Petersburg, 193231, Russia
Almirall Investigational Sites#720
Saint Petersburg, 193312, Russia
Almirall Investigational Sites#965
Saint Petersburg, 193312, Russia
Almirall Investigational Sites#969
Saint Petersburg, 194044, Russia
Almirall Investigational Sites#543
Saint Petersburg, 194291, Russia
Almirall Investigational Sites#787
Saint Petersburg, 194354, Russia
Almirall Investigational Sites#975
Saint Petersburg, 195067, Russia
Almirall Investigational Sites#465
Saint Petersburg, 196247, Russia
Almirall Investigational Sites#966
Saint Petersburg, 196247, Russia
Almirall Investigational Sites#972
Saint Petersburg, 197022, Russia
Almirall Investigational Sites#786
Saint Petersburg, 197089, Russia
Almirall Investigational Sites#963
Saint Petersburg, 198216, Russia
Almirall Investigational Sites#718
Sochi, 354057, Russia
Almirall Investigational Sites#16
Badalona, 08916, Spain
Almirall Investigational Sites#7
Barcelona, 08035, Spain
Almirall Investigational Sites#317
Barcelona, 08036, Spain
Almirall Investigational Sites#61
Madrid, 28006, Spain
Almirall Investigational Sites#938
Málaga, 29010, Spain
Almirall Investigational Sites#727
Palma de Mallorca, 07014, Spain
Almirall Investigational Sites#723
Sant Joan d'Alacant, 03550, Spain
Almirall Investigational Sites#725
Terrassa, 08221, Spain
Almirall Investigational Sites#738
Bedford, MK42 9DJ, United Kingdom
Almirall Investigational Sites#42
Bristol, BS2 8HW, United Kingdom
Almirall Investigational Sites#734
Cottingham, HU16 5JQ, United Kingdom
Almirall Investigational Sites#735
Doncaster, DN2 5LT, United Kingdom
Almirall Investigational Sites#788
Exeter, EX2 5DW, United Kingdom
Almirall Investigational Sites#737
Hereford, HR1 2ER, United Kingdom
Almirall Investigational Sites#784
London, E2 9JX, United Kingdom
Almirall Investigational Sites#37
London, SW17 0RE, United Kingdom
Almirall Investigational Sites#730
Newcastle upon Tyne, NE7 7DN, United Kingdom
Almirall Investigational Sites#731
Peterborough, PE3 6DA, United Kingdom
Almirall Investigational Sites#728
Solihull, B91 2JL, United Kingdom
Almirall Investigational Sites#732
Suffolk, IP33 2QZ, United Kingdom
Almirall Investigational Sites#736
Windsor, SL4 3DP, United Kingdom
Related Publications (1)
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.
PMID: 21518460DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- AstraZeneca Clinical
- Organization
- Study Information Center
Study Officials
- STUDY DIRECTOR
Esther Garcia, MD
AstraZeneca
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
August 10, 2006
First Posted
August 15, 2006
Study Start
July 1, 2006
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
January 6, 2017
Results First Posted
November 1, 2012
Record last verified: 2016-11