- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00363896
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
Status
Completed
Conditions
Intervention / Treatment
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
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Escaldes, Andorra
- Almirall Investigational Sites#947
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Graz, Austria, 8036
- Almirall Investigational Sites#645
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Innsbruck, Austria, 6020
- Almirall Investigational Sites#646
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Linz, Austria, 4010
- Almirall Investigational Sites#644
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Wien, Austria, 1090
- Almirall Investigational Sites#647
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Wien, Austria, 1145
- Almirall Investigational Sites#649
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Aalst, Belgium, 9300
- Almirall Investigational Sites#110
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Brussels, Belgium, 1090
- Almirall Investigational Sites#394
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Edegem, Belgium, 2650
- Almirall Investigational Sites#651
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Namur, Belgium, 5000
- Almirall Investigational Sites#393
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Burgas, Bulgaria, 800
- Almirall Investigational Sites#658
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Pleven, Bulgaria, 5800
- Almirall Investigational Sites#653
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Plovdiv, Bulgaria, 4000
- Almirall Investigational Sites#654
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Russe, Bulgaria, 7000
- Almirall Investigational Sites#656
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Sofia, Bulgaria, 1431
- Almirall Investigational Sites#652
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Sofia, Bulgaria, 1431
- Almirall Investigational Sites#657
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Sofia, Bulgaria, 1431
- Almirall Investigational Sites#972
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Sofia, Bulgaria, 1618
- Almirall Investigational Sites#971
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Varna, Bulgaria, 9010
- Almirall Investigational Sites#655
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Veliko Tarnovo, Bulgaria, 5000
- Almirall Investigational Sites#953
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Lovosice, Czech Republic, 410 02
- Almirall Investigational Sites#664
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Neratovice, Czech Republic, 277 11
- Almirall Investigational Sites#660
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Plzen, Czech Republic, 324 01
- Almirall Investigational Sites#662
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Prague, Czech Republic, 169 02
- Almirall Investigational Sites#666
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Praha, Czech Republic, 182 00
- Almirall Investigational Sites#661
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Tabor, Czech Republic, 390 03
- Almirall Investigational Sites#665
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Tremosna, Czech Republic, 330 11
- Almirall Investigational Sites#659
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Zatec, Czech Republic, 43801
- Almirall Investigational Sites#954
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Aalborg, Denmark, 9100
- Almirall Investigational Sites#398
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Odense C., Denmark, 5000
- Almirall Investigational Sites#397
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Århus C, Denmark, 8000
- Almirall Investigational Sites#390
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Beuvry, France, 62660
- Almirall Investigational Sites#594
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Brest Cedex, France, 29609
- Almirall Investigational Sites#593
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Grasse, France, 06130
- Almirall Investigational Sites#750
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Montpellier,cedex 5, France, 34295
- Almirall Investigational Sites#669
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Paris, France, 75004
- Almirall Investigational Sites#672
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Perpignan Cedex, France, 66025
- Almirall Investigational Sites#948
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Rouen , Cedex, France, 76031
- Almirall Investigational Sites#549
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Strasbourg Cedex, France, 67098
- Almirall Investigational Sites#671
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Vieux Conde, France, 59690
- Almirall Investigational Sites#752
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Bad Wörishofen, Germany, 86825
- Almirall Investigational Sites#678
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Berlin, Germany, 10717
- Almirall Investigational Sites#758
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Berlin, Germany, 10969
- Almirall Investigational Sites#765
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Berlin, Germany, 13125
- Almirall Investigational Sites#680
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Berlin-Spandau, Germany, 13597
- Almirall Investigational Sites#677
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Bonn, Germany, 53123
- Almirall Investigational Sites#681
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Grosshansdorf, Germany, 22927
- Almirall Investigational Sites#191
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Hamburg, Germany, 20249
- Almirall Investigational Sites#766
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Jena, Germany, 07743
- Almirall Investigational Sites#757
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Mainz, Germany, 55131
- Almirall Investigational Sites#675
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Budapest, Hungary, 1117
- Almirall Investigational Sites#684
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Debrecen, Hungary, 4012
- Almirall Investigational Sites#687
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Debrecen, Hungary, 4043
- Almirall Investigational Sites#683
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Nyiregyhaza, Hungary, 4412
- Almirall Investigational Sites#688
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Szekesfehervar, Hungary, 8000
- Almirall Investigational Sites#686
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Szombathely, Hungary, 9700
- Almirall Investigational Sites#689
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Tatabanya, Hungary, 2800
- Almirall Investigational Sites#682
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Torokbalint, Hungary, 2045
- Almirall Investigational Sites#685
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Genova, Italy, 16132
- Almirall Investigational Sites#459
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Milano, Italy, 20142
- Almirall Investigational Sites#774
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Modena, Italy, 41100
- Almirall Investigational Sites#286
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Napoli, Italy, 80131
- Almirall Investigational Sites#694
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Perugia, Italy, 06156
- Almirall Investigational Sites#635
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Pordenone, Italy, 33170
- Almirall Investigational Sites#777
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Breda, Netherlands, 4819 EV
- Almirall Investigational Sites#346
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Eindhoven, Netherlands, 5623 EJ
- Almirall Investigational Sites#551
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Hengelo, Netherlands, 7555 DL
- Almirall Investigational Sites#348
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Hoofddorp, Netherlands, 2134TM
- Almirall Investigational Sites#695
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Lodz, Poland, 90-430
- Almirall Investigational Sites#700
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Lodz, Poland, 91-520
- Almirall Investigational Sites#698
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Torun, Poland, 87-100
- Almirall Investigational Sites#697
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Warszawa, Poland, 01-138
- Almirall Investigational Sites#699
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Warszawa, Poland, 01-337
- Almirall Investigational Sites#696
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Warszawa, Poland, 03-416
- Almirall Investigational Sites#702
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Wroclaw, Poland, 50-434
- Almirall Investigational Sites#706
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Zabrze, Poland, 41-800
- Almirall Investigational Sites#705
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Zawadzkie, Poland, 47-120
- Almirall Investigational Sites#701
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Brasov, Romania, 500326
- Almirall Investigational Sites#962
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Bucharest, Romania, 21659
- Almirall Investigational Sites#714
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Bucuresti, Romania, 0100825
- Almirall Investigational Sites#970
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Cluj-Napoca, Romania, 400371
- Almirall Investigational Sites#713
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Iasi, Romania, 700115
- Almirall Investigational Sites#712
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Judetul Brasov, Romania, 500365
- Almirall Investigational Sites#961
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Palazu Mare, Romania, 900002
- Almirall Investigational Sites#709
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Targu Mures, Romania, 540139
- Almirall Investigational Sites#711
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Timisoara, Romania, 1900
- Almirall Investigational Sites#715
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Moscow, Russian Federation, 105077
- Almirall Investigational Sites#462
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Moscow, Russian Federation, 105077
- Almirall Investigational Sites#977
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Moscow, Russian Federation, 105229
- Almirall Investigational Sites#721
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Moscow, Russian Federation, 109240
- Almirall Investigational Sites#540
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Moscow, Russian Federation, 115446
- Almirall Investigational Sites#967
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Moscow, Russian Federation, 117485
- Almirall Investigational Sites#716
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Moscow, Russian Federation, 119048
- Almirall Investigational Sites#722
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Moscow, Russian Federation, 121359
- Almirall Investigational Sites#719
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Moscow, Russian Federation, 123182
- Almirall Investigational Sites#582
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Moscow, Russian Federation, 123182
- Almirall Investigational Sites#785
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Moscow, Russian Federation, 127018
- Almirall Investigational Sites#976
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Moscow region, Russian Federation, 143405
- Almirall Investigational Sites#717
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Saint Petersburg, Russian Federation, 193231
- Almirall Investigational Sites#588
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Saint Petersburg, Russian Federation, 193312
- Almirall Investigational Sites#720
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Saint Petersburg, Russian Federation, 193312
- Almirall Investigational Sites#965
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Saint Petersburg, Russian Federation, 194291
- Almirall Investigational Sites#543
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Saint Petersburg, Russian Federation, 194354
- Almirall Investigational Sites#787
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Saint Petersburg, Russian Federation, 195067
- Almirall Investigational Sites#975
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Saint Petersburg, Russian Federation, 196247
- Almirall Investigational Sites#465
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Saint Petersburg, Russian Federation, 196247
- Almirall Investigational Sites#966
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Saint Petersburg, Russian Federation, 197022
- Almirall Investigational Sites#972
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Saint Petersburg, Russian Federation, 197089
- Almirall Investigational Sites#786
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Saint Petersburg, Russian Federation, 198216
- Almirall Investigational Sites#963
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Sochi, Russian Federation, 354057
- Almirall Investigational Sites#718
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saint Petersburg, Russian Federation, 194044
- Almirall Investigational Sites#969
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Badalona, Spain, 08916
- Almirall Investigational Sites#16
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Barcelona, Spain, 08035
- Almirall Investigational Sites#7
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Barcelona, Spain, 08036
- Almirall Investigational Sites#317
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Madrid, Spain, 28006
- Almirall Investigational Sites#61
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Málaga, Spain, 29010
- Almirall Investigational Sites#938
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Palma de Mallorca, Spain, 07014
- Almirall Investigational Sites#727
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San Juan de Alicante, Spain, 03550
- Almirall Investigational Sites#723
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Terrassa, Spain, 08221
- Almirall Investigational Sites#725
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Bedford, United Kingdom, MK42 9DJ
- Almirall Investigational Sites#738
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Bristol, United Kingdom, BS2 8HW
- Almirall Investigational Sites#42
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Cottingham, United Kingdom, HU16 5JQ
- Almirall Investigational Sites#734
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Doncaster, United Kingdom, DN2 5LT
- Almirall Investigational Sites#735
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Exeter, United Kingdom, EX2 5DW
- Almirall Investigational Sites#788
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Hereford, United Kingdom, HR1 2ER
- Almirall Investigational Sites#737
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London, United Kingdom, E2 9JX
- Almirall Investigational Sites#784
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London, United Kingdom, SW17 0RE
- Almirall Investigational Sites#37
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Newcastle upon Tyne, United Kingdom, NE7 7DN
- Almirall Investigational Sites#730
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Peterborough, United Kingdom, PE3 6DA
- Almirall Investigational Sites#731
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Solihull, United Kingdom, B91 2JL
- Almirall Investigational Sites#728
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Suffolk, United Kingdom, IP33 2QZ
- Almirall Investigational Sites#732
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Windsor, United Kingdom, SL4 3DP
- Almirall Investigational Sites#736
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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 |
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Experimental: Aclidinium 200 μg once-daily
Aclidinium bromide 200 μg once-daily by inhalation
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Aclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks
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Placebo Comparator: Placebo
Placebo once-daily via inhalation
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Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks
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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
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Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks
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Week 28
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Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment
Time Frame: Week 12
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Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks
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Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment
Time Frame: Week 52
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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
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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
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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
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52 weeks
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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.
Helpful Links
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
Keywords
Additional Relevant MeSH Terms
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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