Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT00363896
A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Aclidinium bromide in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 132 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Aclidinium bromide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 843 participants
- Where
- 132 sitesin 16 countries
- Study dates
- Jul 2006to May 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD
Who cannot join
- 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
Trial locations and contacts
132 sites in 16 countries.
132 sites in 16 countries
Russia25 sites
Almirall Investigational Sites#462
Moscow, 105077
Almirall Investigational Sites#977
Moscow, 105077
Almirall Investigational Sites#721
Moscow, 105229
Almirall Investigational Sites#540
Moscow, 109240
Almirall Investigational Sites#967
Moscow, 115446
Almirall Investigational Sites#716
Moscow, 117485
Almirall Investigational Sites#722
Moscow, 119048
Almirall Investigational Sites#719
Moscow, 121359
Almirall Investigational Sites#582
Moscow, 123182
Almirall Investigational Sites#785
Moscow, 123182
Almirall Investigational Sites#976
Moscow, 127018
Almirall Investigational Sites#717
Moscow Region, 143405
Almirall Investigational Sites#588
Saint Petersburg, 193231
Almirall Investigational Sites#720
Saint Petersburg, 193312
Almirall Investigational Sites#965
Saint Petersburg, 193312
Almirall Investigational Sites#969
Saint Petersburg, 194044
Almirall Investigational Sites#543
Saint Petersburg, 194291
Almirall Investigational Sites#787
Saint Petersburg, 194354
Almirall Investigational Sites#975
Saint Petersburg, 195067
Almirall Investigational Sites#465
Saint Petersburg, 196247
Almirall Investigational Sites#966
Saint Petersburg, 196247
Almirall Investigational Sites#972
Saint Petersburg, 197022
Almirall Investigational Sites#786
Saint Petersburg, 197089
Almirall Investigational Sites#963
Saint Petersburg, 198216
Almirall Investigational Sites#718
Sochi, 354057
United Kingdom13 sites
Almirall Investigational Sites#738
Bedford, MK42 9DJ
Almirall Investigational Sites#42
Bristol, BS2 8HW
Almirall Investigational Sites#734
Cottingham, HU16 5JQ
Almirall Investigational Sites#735
Doncaster, DN2 5LT
Almirall Investigational Sites#788
Exeter, EX2 5DW
Almirall Investigational Sites#737
Hereford, HR1 2ER
Almirall Investigational Sites#784
London, E2 9JX
Almirall Investigational Sites#37
London, SW17 0RE
Almirall Investigational Sites#730
Newcastle upon Tyne, NE7 7DN
Almirall Investigational Sites#731
Peterborough, PE3 6DA
Almirall Investigational Sites#728
Solihull, B91 2JL
Almirall Investigational Sites#732
Suffolk, IP33 2QZ
Almirall Investigational Sites#736
Windsor, SL4 3DP
Bulgaria10 sites
Almirall Investigational Sites#658
Burgas, 800
Almirall Investigational Sites#653
Pleven, 5800
Almirall Investigational Sites#654
Plovdiv, 4000
Almirall Investigational Sites#656
Rousse, 7000
Almirall Investigational Sites#652
Sofia, 1431
Almirall Investigational Sites#657
Sofia, 1431
Almirall Investigational Sites#972
Sofia, 1431
Almirall Investigational Sites#971
Sofia, 1618
Almirall Investigational Sites#655
Varna, 9010
Almirall Investigational Sites#953
Veliko Tarnovo, 5000
Germany10 sites
Almirall Investigational Sites#678
Bad Wörishofen, 86825
Almirall Investigational Sites#758
Berlin, 10717
Almirall Investigational Sites#765
Berlin, 10969
Almirall Investigational Sites#680
Berlin, 13125
Almirall Investigational Sites#677
Berlin-Spandau, 13597
Almirall Investigational Sites#681
Bonn, 53123
Almirall Investigational Sites#191
Großhansdorf, 22927
Almirall Investigational Sites#766
Hamburg, 20249
Almirall Investigational Sites#757
Jena, 07743
Almirall Investigational Sites#675
Mainz, 55131
France9 sites
Almirall Investigational Sites#594
Beuvry, 62660
Almirall Investigational Sites#593
Brest, 29609
Almirall Investigational Sites#750
Grasse, 06130
Almirall Investigational Sites#669
Montpellier, 34295
Almirall Investigational Sites#672
Paris, 75004
Almirall Investigational Sites#948
Perpignan, 66025
Almirall Investigational Sites#549
Rouen, 76031
Almirall Investigational Sites#671
Strasbourg, 67098
Almirall Investigational Sites#752
Vieux-Condé, 59690
Poland9 sites
Almirall Investigational Sites#700
Lodz, 90-430
Almirall Investigational Sites#698
Lodz, 91-520
Almirall Investigational Sites#697
Torun, 87-100
Almirall Investigational Sites#699
Warsaw, 01-138
Almirall Investigational Sites#696
Warsaw, 01-337
Almirall Investigational Sites#702
Warsaw, 03-416
Almirall Investigational Sites#706
Wroclaw, 50-434
Almirall Investigational Sites#705
Zabrze, 41-800
Almirall Investigational Sites#701
Zawadzkie, 47-120
Romania9 sites
Almirall Investigational Sites#962
Brasov, 500326
Almirall Investigational Sites#970
Bucharest, 0100825
Almirall Investigational Sites#714
Bucharest, 21659
Almirall Investigational Sites#713
Cluj-Napoca, 400371
Almirall Investigational Sites#712
Iași, 700115
Almirall Investigational Sites#961
Judetul Brasov, 500365
Almirall Investigational Sites#709
Palazu Mare, 900002
Almirall Investigational Sites#711
Târgu Mureş, 540139
Almirall Investigational Sites#715
Timișoara, 1900
Czechia8 sites
Almirall Investigational Sites#664
Lovosice, 410 02
Almirall Investigational Sites#660
Neratovice, 277 11
Almirall Investigational Sites#662
Pilsen, 324 01
Almirall Investigational Sites#666
Prague, 169 02
Almirall Investigational Sites#661
Prague, 182 00
Almirall Investigational Sites#665
Tábor, 390 03
Almirall Investigational Sites#659
Třemošná, 330 11
Almirall Investigational Sites#954
Žatec, 43801
Hungary8 sites
Almirall Investigational Sites#684
Budapest, 1117
Almirall Investigational Sites#687
Debrecen, 4012
Almirall Investigational Sites#683
Debrecen, 4043
Almirall Investigational Sites#688
Nyíregyháza, 4412
Almirall Investigational Sites#686
Székesfehérvár, 8000
Almirall Investigational Sites#689
Szombathely, 9700
Almirall Investigational Sites#682
Tatabánya, 2800
Almirall Investigational Sites#685
Törökbálint, 2045
Spain8 sites
Almirall Investigational Sites#16
Badalona, 08916
Almirall Investigational Sites#7
Barcelona, 08035
Almirall Investigational Sites#317
Barcelona, 08036
Almirall Investigational Sites#61
Madrid, 28006
Almirall Investigational Sites#938
Málaga, 29010
Almirall Investigational Sites#727
Palma de Mallorca, 07014
Almirall Investigational Sites#723
Sant Joan d'Alacant, 03550
Almirall Investigational Sites#725
Terrassa, 08221
Italy6 sites
Almirall Investigational Sites#459
Genova, 16132
Almirall Investigational Sites#774
Milan, 20142
Almirall Investigational Sites#286
Modena, 41100
Almirall Investigational Sites#694
Naples, 80131
Almirall Investigational Sites#635
Perugia, 06156
Almirall Investigational Sites#777
Pordenone, 33170
Austria5 sites
Almirall Investigational Sites#645
Graz, 8036
Almirall Investigational Sites#646
Innsbruck, 6020
Almirall Investigational Sites#644
Linz, 4010
Almirall Investigational Sites#647
Vienna, 1090
Almirall Investigational Sites#649
Vienna, 1145
Belgium4 sites
Almirall Investigational Sites#110
Aalst, 9300
Almirall Investigational Sites#394
Brussels, 1090
Almirall Investigational Sites#651
Edegem, 2650
Almirall Investigational Sites#393
Namur, 5000
Netherlands4 sites
Almirall Investigational Sites#346
Breda, 4819 EV
Almirall Investigational Sites#551
Eindhoven, 5623 EJ
Almirall Investigational Sites#348
Hengelo, 7555 DL
Almirall Investigational Sites#695
Hoofddorp, 2134TM
Denmark3 sites
Almirall Investigational Sites#398
Aalborg, 9100
Almirall Investigational Sites#390
Århus C, 8000
Almirall Investigational Sites#397
Odense C, 5000
Andorra1 site
Almirall Investigational Sites#947
Les Escaldes
About this study
Official title: 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.
- Being tested
- Aclidinium bromide, Placebo
- Keywords
- COPD, Lung function, Exacerbations, Quality of Life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aclidinium bromideDrug
Aclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks
PlaceboDrug
Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aclidinium 200 μg once-daily | Experimental | Aclidinium bromide 200 μg once-daily by inhalation Receives: Drug: Aclidinium bromide |
| Placebo | Placebo comparator | Placebo once-daily via inhalation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Week 12
Secondary outcomes (2)
Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment
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.
Measured: 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
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
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Esther Garcia, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363896
- Sponsor's protocol ID
- M/34273/30
- Other IDs
- ACCLAIM I, CT000740
- Status last verified
- Nov 2016
- First submitted
- 10 Aug 2006
- Last updated
- 6 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Spata E, Jauhiainen A, Da Silva CA. Impact of season and geography on COPDCompEx: a composite endpoint for COPD trials. Respir Med Res. 2026 Jul 12;90:101305. doi: 10.1016/j.resmer.2026.101305. Online ahead of print.
PubMed 42551404Jones 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.
PubMed 21518460
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
- ClinicalTrials.gov ID
- NCT00363896
- Acronym / sponsor ID
- M/34273/30
- Keywords
- COPD, Lung function, Exacerbations, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Posted 1 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aclidinium 200 μg once-daily | Experimental | Drug: Aclidinium bromideAclidinium bromide 200 μg once-daily by inhalation |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once-daily via inhalation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aclidinium bromideAclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks | Drug | Aclidinium 200 μg once-daily |
| PlaceboPlacebo once-daily via inhalation: 1 puff in the morning for 52 weeks | Drug | Placebo |
Primary outcome
Trough FEV1 (L) at 28 Weeks on Treatment
Time frame: 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
Time frame: Week 12
Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks
2 secondary outcomes
Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment
Time frame: 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
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42551404Spata E, Jauhiainen A, Da Silva CA. Impact of season and geography on COPDCompEx: a composite endpoint for COPD trials. Respir Med Res. 2026 Jul 12;90:101305. doi: 10.1016/j.resmer.2026.101305. Online ahead of print.
- Derived from this study: PubMed 21518460Jones 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.
- Sponsor web siteLink provided by the sponsor.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Garcia, MD study director
AstraZeneca
132 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aclidinium bromide in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 132 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 132 sites in Russia, United Kingdom, Bulgaria, Germany, France and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trough FEV1 (L) at 28 Weeks on Treatment (time frame: Week 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00363896, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.