A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: 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 ≥ 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 μg once-daily Aclidinium bromide Aclidinium bromide 200 μg 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
🇫🇷Montpellier,cedex 5, France
Almirall Investigational Sites#397
🇩🇰Odense C., Denmark
Almirall Investigational Sites#757
🇩🇪Jena, Germany
Almirall Investigational Sites#680
🇩🇪Berlin, Germany
Almirall Investigational Sites#677
🇩🇪Berlin-Spandau, Germany
Almirall Investigational Sites#750
🇫🇷Grasse, France
Almirall Investigational Sites#549
🇫🇷Rouen , Cedex, France
Almirall Investigational Sites#649
🇦🇹Wien, Austria
Almirall Investigational Sites#110
🇧🇪Aalst, Belgium
Almirall Investigational Sites#947
🇦🇩Escaldes, Andorra
Almirall Investigational Sites#765
🇩🇪Berlin, Germany
Almirall Investigational Sites#645
🇦🇹Graz, Austria
Almirall Investigational Sites#671
🇫🇷Strasbourg Cedex, France
Almirall Investigational Sites#551
🇳🇱Eindhoven, Netherlands
Almirall Investigational Sites#540
🇷🇺Moscow, Russian Federation
Almirall Investigational Sites#752
🇫🇷Vieux Conde, France
Almirall Investigational Sites#678
🇩🇪Bad Wörishofen, Germany
Almirall Investigational Sites#660
🇨🇿Neratovice, Czech Republic
Almirall Investigational Sites#394
🇧🇪Brussels, Belgium
Almirall Investigational Sites#459
🇮🇹Genova, Italy
Almirall Investigational Sites#635
🇮🇹Perugia, Italy
Almirall Investigational Sites#967
🇷🇺Moscow, Russian Federation
Almirall Investigational Sites#758
🇩🇪Berlin, Germany
Almirall Investigational Sites#685
🇭🇺Torokbalint, Hungary
Almirall Investigational Sites#766
🇩🇪Hamburg, Germany
Almirall Investigational Sites#694
🇮🇹Napoli, Italy
Almirall Investigational Sites#777
🇮🇹Pordenone, Italy
Almirall Investigational Sites#462
🇷🇺Moscow, Russian Federation
Almirall Investigational Sites#721
🇷🇺Moscow, Russian Federation
Almirall Investigational Sites#7
🇪🇸Barcelona, Spain
Almirall Investigational Sites#191
🇩🇪Grosshansdorf, Germany
Almirall Investigational Sites#658
🇧🇬Burgas, Bulgaria
Almirall Investigational Sites#717
🇷🇺Moscow region, Russian Federation
Almirall Investigational Sites#699
🇵🇱Warszawa, Poland
Almirall Investigational Sites#713
🇷🇴Cluj-Napoca, Romania
Almirall Investigational Sites#672
🇫🇷Paris, France
Almirall Investigational Sites#785
🇷🇺Moscow, Russian Federation
Almirall Investigational Sites#784
🇬🇧London, United Kingdom
Almirall Investigational Sites#786
🇷🇺Saint Petersburg, Russian Federation
Almirall Investigational Sites#686
🇭🇺Szekesfehervar, Hungary
Almirall Investigational Sites#681
🇩🇪Bonn, Germany
Almirall Investigational Sites#938
🇪🇸Málaga, Spain
Almirall Investigational Sites#697
🇵🇱Torun, Poland
Almirall Investigational Sites#706
🇵🇱Wroclaw, Poland
Almirall Investigational Sites#709
🇷🇴Palazu Mare, Romania
Almirall Investigational Sites#346
🇳🇱Breda, Netherlands
Almirall Investigational Sites#734
🇬🇧Cottingham, United Kingdom
Almirall Investigational Sites#977
🇷🇺Moscow, Russian Federation
Almirall Investigational Sites#582
🇷🇺Moscow, Russian Federation
Almirall Investigational Sites#588
🇷🇺Saint Petersburg, Russian Federation
Almirall Investigational Sites#718
🇷🇺Sochi, Russian Federation
Almirall Investigational Sites#727
🇪🇸Palma de Mallorca, Spain
Almirall Investigational Sites#966
🇷🇺Saint Petersburg, Russian Federation
Almirall Investigational Sites#965
🇷🇺Saint Petersburg, Russian Federation
Almirall Investigational Sites#788
🇬🇧Exeter, United Kingdom
Almirall Investigational Sites#16
🇪🇸Badalona, Spain
Almirall Investigational Sites#61
🇪🇸Madrid, Spain
Almirall Investigational Sites#737
🇬🇧Hereford, United Kingdom
Almirall Investigational Sites#725
🇪🇸Terrassa, Spain
Almirall Investigational Sites#42
🇬🇧Bristol, United Kingdom
Almirall Investigational Sites#37
🇬🇧London, United Kingdom
Almirall Investigational Sites#711
🇷🇴Targu Mures, Romania
Almirall Investigational Sites#348
🇳🇱Hengelo, Netherlands
Almirall Investigational Sites#695
🇳🇱Hoofddorp, Netherlands
Almirall Investigational Sites#730
🇬🇧Newcastle upon Tyne, United Kingdom
Almirall Investigational Sites#722
🇷🇺Moscow, Russian Federation
Almirall Investigational Sites#969
🇷🇺saint Petersburg, Russian Federation
Almirall Investigational Sites#976
🇷🇺Moscow, Russian Federation
Almirall Investigational Sites#975
🇷🇺Saint Petersburg, Russian Federation
Almirall Investigational Sites#465
🇷🇺Saint Petersburg, Russian Federation
Almirall Investigational Sites#716
🇷🇺Moscow, Russian Federation
Almirall Investigational Sites#317
🇪🇸Barcelona, Spain
Almirall Investigational Sites#644
🇦🇹Linz, Austria
Almirall Investigational Sites#646
🇦🇹Innsbruck, Austria
Almirall Investigational Sites#647
🇦🇹Wien, Austria
Almirall Investigational Sites#651
🇧🇪Edegem, Belgium
Almirall Investigational Sites#656
🇧🇬Russe, Bulgaria
Almirall Investigational Sites#971
🇧🇬Sofia, Bulgaria
Almirall Investigational Sites#393
🇧🇪Namur, Belgium
Almirall Investigational Sites#653
🇧🇬Pleven, Bulgaria
Almirall Investigational Sites#972
🇷🇺Saint Petersburg, Russian Federation
Almirall Investigational Sites#654
🇧🇬Plovdiv, Bulgaria
Almirall Investigational Sites#657
🇧🇬Sofia, Bulgaria
Almirall Investigational Sites#652
🇧🇬Sofia, Bulgaria
Almirall Investigational Sites#662
🇨🇿Plzen, Czech Republic
Almirall Investigational Sites#953
🇧🇬Veliko Tarnovo, Bulgaria
Almirall Investigational Sites#655
🇧🇬Varna, Bulgaria
Almirall Investigational Sites#659
🇨🇿Tremosna, Czech Republic
Almirall Investigational Sites#665
🇨🇿Tabor, Czech Republic
Almirall Investigational Sites#398
🇩🇰Aalborg, Denmark
Almirall Investigational Sites#390
🇩🇰Århus C, Denmark
Almirall Investigational Sites#594
🇫🇷Beuvry, France
Almirall Investigational Sites#593
🇫🇷Brest Cedex, France
Almirall Investigational Sites#948
🇫🇷Perpignan Cedex, France
Almirall Investigational Sites#675
🇩🇪Mainz, Germany
Almirall Investigational Sites#684
🇭🇺Budapest, Hungary
Almirall Investigational Sites#687
🇭🇺Debrecen, Hungary
Almirall Investigational Sites#688
🇭🇺Nyiregyhaza, Hungary
Almirall Investigational Sites#682
🇭🇺Tatabanya, Hungary
Almirall Investigational Sites#689
🇭🇺Szombathely, Hungary
Almirall Investigational Sites#774
🇮🇹Milano, Italy
Almirall Investigational Sites#286
🇮🇹Modena, Italy
Almirall Investigational Sites#714
🇷🇴Bucharest, Romania
Almirall Investigational Sites#961
🇷🇴Judetul Brasov, Romania
Almirall Investigational Sites#719
🇷🇺Moscow, Russian Federation
Almirall Investigational Sites#787
🇷🇺Saint Petersburg, Russian Federation
Almirall Investigational Sites#543
🇷🇺Saint Petersburg, Russian Federation
Almirall Investigational Sites#735
🇬🇧Doncaster, United Kingdom
Almirall Investigational Sites#723
🇪🇸San Juan de Alicante, Spain
Almirall Investigational Sites#738
🇬🇧Bedford, United Kingdom
Almirall Investigational Sites#731
🇬🇧Peterborough, United Kingdom
Almirall Investigational Sites#732
🇬🇧Suffolk, United Kingdom
Almirall Investigational Sites#728
🇬🇧Solihull, United Kingdom
Almirall Investigational Sites#736
🇬🇧Windsor, United Kingdom
Almirall Investigational Sites#720
🇷🇺Saint Petersburg, Russian Federation
Almirall Investigational Sites#683
🇭🇺Debrecen, Hungary
Almirall Investigational Sites#963
🇷🇺Saint Petersburg, Russian Federation
Almirall Investigational Sites#702
🇵🇱Warszawa, Poland
Almirall Investigational Sites#970
🇷🇴Bucuresti, Romania
Almirall Investigational Sites#712
🇷🇴Iasi, Romania
Almirall Investigational Sites#664
🇨🇿Lovosice, Czech Republic
Almirall Investigational Sites#705
🇵🇱Zabrze, Poland
Almirall Investigational Sites#661
🇨🇿Praha, Czech Republic
Almirall Investigational Sites#954
🇨🇿Zatec, Czech Republic
Almirall Investigational Sites#701
🇵🇱Zawadzkie, Poland
Almirall Investigational Sites#962
🇷🇴Brasov, Romania
Almirall Investigational Sites#666
🇨🇿Prague, Czech Republic
Almirall Investigational Sites#700
🇵🇱Lodz, Poland
Almirall Investigational Sites#698
🇵🇱Lodz, Poland
Almirall Investigational Sites#696
🇵🇱Warszawa, Poland
Almirall Investigational Sites#715
🇷🇴Timisoara, Romania