A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: Aclidinium bromideDrug: Placebo
- Registration Number
- NCT00363896
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 843
- Males and females aged โฅ 40 years with a clinical diagnosis of moderate to severe stable COPD
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aclidinium 200 ฮผg once-daily Aclidinium bromide Aclidinium bromide 200 ฮผg once-daily by inhalation Placebo Placebo Placebo once-daily via inhalation
- Primary Outcome Measures
Name Time Method Trough FEV1 (L) at 28 Weeks on Treatment Week 28 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 Week 12 Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks
- Secondary Outcome Measures
Name Time Method Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment 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.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 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
Trial Locations
- Locations (131)
Almirall Investigational Sites#669
๐ซ๐ทMontpellier,cedex 5, France
Almirall Investigational Sites#397
๐ฉ๐ฐOdense C., Denmark
Almirall Investigational Sites#757
๐ฉ๐ชJena, Germany
Almirall Investigational Sites#680
๐ฉ๐ชBerlin, Germany
Almirall Investigational Sites#677
๐ฉ๐ชBerlin-Spandau, Germany
Almirall Investigational Sites#750
๐ซ๐ทGrasse, France
Almirall Investigational Sites#549
๐ซ๐ทRouen , Cedex, France
Almirall Investigational Sites#649
๐ฆ๐นWien, Austria
Almirall Investigational Sites#110
๐ง๐ชAalst, Belgium
Almirall Investigational Sites#947
๐ฆ๐ฉEscaldes, Andorra
Almirall Investigational Sites#765
๐ฉ๐ชBerlin, Germany
Almirall Investigational Sites#645
๐ฆ๐นGraz, Austria
Almirall Investigational Sites#671
๐ซ๐ทStrasbourg Cedex, France
Almirall Investigational Sites#551
๐ณ๐ฑEindhoven, Netherlands
Almirall Investigational Sites#540
๐ท๐บMoscow, Russian Federation
Almirall Investigational Sites#752
๐ซ๐ทVieux Conde, France
Almirall Investigational Sites#678
๐ฉ๐ชBad Wรถrishofen, Germany
Almirall Investigational Sites#660
๐จ๐ฟNeratovice, Czech Republic
Almirall Investigational Sites#394
๐ง๐ชBrussels, Belgium
Almirall Investigational Sites#459
๐ฎ๐นGenova, Italy
Almirall Investigational Sites#635
๐ฎ๐นPerugia, Italy
Almirall Investigational Sites#967
๐ท๐บMoscow, Russian Federation
Almirall Investigational Sites#758
๐ฉ๐ชBerlin, Germany
Almirall Investigational Sites#685
๐ญ๐บTorokbalint, Hungary
Almirall Investigational Sites#766
๐ฉ๐ชHamburg, Germany
Almirall Investigational Sites#694
๐ฎ๐นNapoli, Italy
Almirall Investigational Sites#777
๐ฎ๐นPordenone, Italy
Almirall Investigational Sites#462
๐ท๐บMoscow, Russian Federation
Almirall Investigational Sites#721
๐ท๐บMoscow, Russian Federation
Almirall Investigational Sites#7
๐ช๐ธBarcelona, Spain
Almirall Investigational Sites#191
๐ฉ๐ชGrosshansdorf, Germany
Almirall Investigational Sites#658
๐ง๐ฌBurgas, Bulgaria
Almirall Investigational Sites#717
๐ท๐บMoscow region, Russian Federation
Almirall Investigational Sites#699
๐ต๐ฑWarszawa, Poland
Almirall Investigational Sites#713
๐ท๐ดCluj-Napoca, Romania
Almirall Investigational Sites#672
๐ซ๐ทParis, France
Almirall Investigational Sites#785
๐ท๐บMoscow, Russian Federation
Almirall Investigational Sites#784
๐ฌ๐งLondon, United Kingdom
Almirall Investigational Sites#786
๐ท๐บSaint Petersburg, Russian Federation
Almirall Investigational Sites#686
๐ญ๐บSzekesfehervar, Hungary
Almirall Investigational Sites#681
๐ฉ๐ชBonn, Germany
Almirall Investigational Sites#938
๐ช๐ธMรกlaga, Spain
Almirall Investigational Sites#697
๐ต๐ฑTorun, Poland
Almirall Investigational Sites#706
๐ต๐ฑWroclaw, Poland
Almirall Investigational Sites#709
๐ท๐ดPalazu Mare, Romania
Almirall Investigational Sites#346
๐ณ๐ฑBreda, Netherlands
Almirall Investigational Sites#734
๐ฌ๐งCottingham, United Kingdom
Almirall Investigational Sites#977
๐ท๐บMoscow, Russian Federation
Almirall Investigational Sites#582
๐ท๐บMoscow, Russian Federation
Almirall Investigational Sites#588
๐ท๐บSaint Petersburg, Russian Federation
Almirall Investigational Sites#718
๐ท๐บSochi, Russian Federation
Almirall Investigational Sites#727
๐ช๐ธPalma de Mallorca, Spain
Almirall Investigational Sites#966
๐ท๐บSaint Petersburg, Russian Federation
Almirall Investigational Sites#965
๐ท๐บSaint Petersburg, Russian Federation
Almirall Investigational Sites#788
๐ฌ๐งExeter, United Kingdom
Almirall Investigational Sites#16
๐ช๐ธBadalona, Spain
Almirall Investigational Sites#61
๐ช๐ธMadrid, Spain
Almirall Investigational Sites#737
๐ฌ๐งHereford, United Kingdom
Almirall Investigational Sites#725
๐ช๐ธTerrassa, Spain
Almirall Investigational Sites#42
๐ฌ๐งBristol, United Kingdom
Almirall Investigational Sites#37
๐ฌ๐งLondon, United Kingdom
Almirall Investigational Sites#711
๐ท๐ดTargu Mures, Romania
Almirall Investigational Sites#348
๐ณ๐ฑHengelo, Netherlands
Almirall Investigational Sites#695
๐ณ๐ฑHoofddorp, Netherlands
Almirall Investigational Sites#730
๐ฌ๐งNewcastle upon Tyne, United Kingdom
Almirall Investigational Sites#722
๐ท๐บMoscow, Russian Federation
Almirall Investigational Sites#969
๐ท๐บsaint Petersburg, Russian Federation
Almirall Investigational Sites#976
๐ท๐บMoscow, Russian Federation
Almirall Investigational Sites#975
๐ท๐บSaint Petersburg, Russian Federation
Almirall Investigational Sites#465
๐ท๐บSaint Petersburg, Russian Federation
Almirall Investigational Sites#716
๐ท๐บMoscow, Russian Federation
Almirall Investigational Sites#317
๐ช๐ธBarcelona, Spain
Almirall Investigational Sites#644
๐ฆ๐นLinz, Austria
Almirall Investigational Sites#646
๐ฆ๐นInnsbruck, Austria
Almirall Investigational Sites#647
๐ฆ๐นWien, Austria
Almirall Investigational Sites#651
๐ง๐ชEdegem, Belgium
Almirall Investigational Sites#656
๐ง๐ฌRusse, Bulgaria
Almirall Investigational Sites#971
๐ง๐ฌSofia, Bulgaria
Almirall Investigational Sites#393
๐ง๐ชNamur, Belgium
Almirall Investigational Sites#653
๐ง๐ฌPleven, Bulgaria
Almirall Investigational Sites#972
๐ท๐บSaint Petersburg, Russian Federation
Almirall Investigational Sites#654
๐ง๐ฌPlovdiv, Bulgaria
Almirall Investigational Sites#657
๐ง๐ฌSofia, Bulgaria
Almirall Investigational Sites#652
๐ง๐ฌSofia, Bulgaria
Almirall Investigational Sites#662
๐จ๐ฟPlzen, Czech Republic
Almirall Investigational Sites#953
๐ง๐ฌVeliko Tarnovo, Bulgaria
Almirall Investigational Sites#655
๐ง๐ฌVarna, Bulgaria
Almirall Investigational Sites#659
๐จ๐ฟTremosna, Czech Republic
Almirall Investigational Sites#665
๐จ๐ฟTabor, Czech Republic
Almirall Investigational Sites#398
๐ฉ๐ฐAalborg, Denmark
Almirall Investigational Sites#390
๐ฉ๐ฐร rhus C, Denmark
Almirall Investigational Sites#594
๐ซ๐ทBeuvry, France
Almirall Investigational Sites#593
๐ซ๐ทBrest Cedex, France
Almirall Investigational Sites#948
๐ซ๐ทPerpignan Cedex, France
Almirall Investigational Sites#675
๐ฉ๐ชMainz, Germany
Almirall Investigational Sites#684
๐ญ๐บBudapest, Hungary
Almirall Investigational Sites#687
๐ญ๐บDebrecen, Hungary
Almirall Investigational Sites#688
๐ญ๐บNyiregyhaza, Hungary
Almirall Investigational Sites#682
๐ญ๐บTatabanya, Hungary
Almirall Investigational Sites#689
๐ญ๐บSzombathely, Hungary
Almirall Investigational Sites#774
๐ฎ๐นMilano, Italy
Almirall Investigational Sites#286
๐ฎ๐นModena, Italy
Almirall Investigational Sites#714
๐ท๐ดBucharest, Romania
Almirall Investigational Sites#961
๐ท๐ดJudetul Brasov, Romania
Almirall Investigational Sites#719
๐ท๐บMoscow, Russian Federation
Almirall Investigational Sites#787
๐ท๐บSaint Petersburg, Russian Federation
Almirall Investigational Sites#543
๐ท๐บSaint Petersburg, Russian Federation
Almirall Investigational Sites#735
๐ฌ๐งDoncaster, United Kingdom
Almirall Investigational Sites#723
๐ช๐ธSan Juan de Alicante, Spain
Almirall Investigational Sites#738
๐ฌ๐งBedford, United Kingdom
Almirall Investigational Sites#731
๐ฌ๐งPeterborough, United Kingdom
Almirall Investigational Sites#732
๐ฌ๐งSuffolk, United Kingdom
Almirall Investigational Sites#728
๐ฌ๐งSolihull, United Kingdom
Almirall Investigational Sites#736
๐ฌ๐งWindsor, United Kingdom
Almirall Investigational Sites#720
๐ท๐บSaint Petersburg, Russian Federation
Almirall Investigational Sites#683
๐ญ๐บDebrecen, Hungary
Almirall Investigational Sites#963
๐ท๐บSaint Petersburg, Russian Federation
Almirall Investigational Sites#702
๐ต๐ฑWarszawa, Poland
Almirall Investigational Sites#970
๐ท๐ดBucuresti, Romania
Almirall Investigational Sites#712
๐ท๐ดIasi, Romania
Almirall Investigational Sites#664
๐จ๐ฟLovosice, Czech Republic
Almirall Investigational Sites#705
๐ต๐ฑZabrze, Poland
Almirall Investigational Sites#661
๐จ๐ฟPraha, Czech Republic
Almirall Investigational Sites#954
๐จ๐ฟZatec, Czech Republic
Almirall Investigational Sites#701
๐ต๐ฑZawadzkie, Poland
Almirall Investigational Sites#962
๐ท๐ดBrasov, Romania
Almirall Investigational Sites#666
๐จ๐ฟPrague, Czech Republic
Almirall Investigational Sites#700
๐ต๐ฑLodz, Poland
Almirall Investigational Sites#698
๐ต๐ฑLodz, Poland
Almirall Investigational Sites#696
๐ต๐ฑWarszawa, Poland
Almirall Investigational Sites#715
๐ท๐ดTimisoara, Romania