Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT00358436
Efficacy and Safety of LAS 34273 in Patients With 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 120 sites in 7 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
- 804 participants
- Where
- 120 sitesin 7 countries
- Study dates
- Aug 2006to Jun 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
120 sites in 7 countries.
120 sites in 7 countries
United States73 sites
Almirall Investigational Sites#896
Albuquerque, New Mexico, 87108
Almirall Investigational Sites#890
Atlanta, Georgia, 30309
Almirall Investigational Sites#843
Baltimore, Maryland, 21201
Almirall Investigational Sites#844
Bay Pines, Florida, 33744
Almirall Investigational Sites#883
Biddeford, Maine, 04005
Almirall Investigational Sites#876
Bowling Green, Kentucky, 42101
Almirall Investigational Sites#906
Butte, Montana, 59701
Almirall Investigational Sites#868
Cadillac, Michigan, 49601
Almirall Investigational Sites#932
Carmichael, California, 95837
Almirall Investigational Sites#861
Chapel Hill, North Carolina, 27599
Almirall Investigational Sites#910
Charleston, South Carolina, 29406
Almirall Investigational Sites#919
Charlotte, North Carolina, 28207
Almirall Investigational Sites#846
Cherry Hill, New Jersey, 08003
Almirall Investigational Sites#933
Chicago, Illinois, 60612
Almirall Investigational Sites#848
Cincinnati, Ohio, 45231
Almirall Investigational Sites#870
Cincinnati, Ohio, 45242
Almirall Investigational Sites#863
Clearwater, Florida, 33765
Almirall Investigational Sites#847
Columbus, Ohio, 43215
Almirall Investigational Sites#898
Dallas, Texas, 75246
Almirall Investigational Sites#907
Decatur, Georgia, 30033
Almirall Investigational Sites#152
DeLand, Florida, 32720
Almirall Investigational Sites#895
Denver, Colorado, 80206
Almirall Investigational Sites#878
Elizabeth City, North Carolina, 27909
Almirall Investigational Sites#904
Encinitas, California, 92024
Almirall Investigational Sites#905
Eugene, Oregon, 97401
Almirall Investigational Sites#864
Evansville, Indiana, 47714
Almirall Investigational Sites#923
Florence, Kentucky, 41042
Almirall Investigational Sites#880
Fort Collins, Colorado, 80528
Almirall Investigational Sites#854
Fort Worth, Texas, 76104
Almirall Investigational Sites#903
Fullerton, California, 92835
Almirall Investigational Sites#931
Gainesville, Georgia, 30501
Almirall Investigational Sites#918
Greer, South Carolina, 29651
Almirall Investigational Sites#872
Hines, Illinois, 60141
Almirall Investigational Sites#875
Houston, Texas, 77030
Almirall Investigational Sites#926
Jasper, Alabama, 35501
Almirall Investigational Sites#866
Lafayette, Louisiana, 70503
Almirall Investigational Sites#976
Lewiston, Maine, 04240
Almirall Investigational Sites#879
Little Rock, Arkansas, 72205-7199
Almirall Investigational Sites#930
Los Angeles, California, 90048
Almirall Investigational Sites#922
Los Angeles, California, 90095-1690
Almirall Investigational Sites#849
Marietta, Georgia, 30060
Almirall Investigational Sites#860
Medford, Oregon, 97504
Almirall Investigational Sites#886
Medford, Oregon, 97504
Almirall Investigational Sites#8533
Melbourne, Florida, 32935
Almirall Investigational Sites#856
Milwaukee, Wisconsin, 53209
Almirall Investigational Sites#884
Minneapolis, Minnesota, 55402
Almirall Investigational Sites#885
Newark, New Jersey, 07112
Almirall Investigational Sites#893
North Hills, California, 91343
Almirall Investigational Sites#909
Omaha, Nebraska, 68198-2465
Almirall Investigational Sites#858
Ozark, Alabama, 36360
Almirall Investigational Sites#900
Phoenix, Arizona, 85023
Almirall Investigational Sites#871
Rancho Mirage, California, 92270
Almirall Investigational Sites#951
Richmond, Virginia, 23225
Almirall Investigational Sites#892
River Forest, Illinois, 60305
Almirall Investigational Sites#902
Riverside, California, 92506
Almirall Investigational Sites#916
Saint Charles, Missouri, 63301
Almirall Investigational Sites#881
San Antonio, Texas, 78229
Almirall Investigational Sites#850
San Diego, California, 92120
Almirall Investigational Sites#897
San Diego, California, 92120
Almirall Investigational Sites#911
Shreveport, Louisiana, 71103
Almirall Investigational Sites#921
Summit, New Jersey, 07901
Almirall Investigational Sites#928
Sylvania, Ohio, 43560
Almirall Investigational Sites#920
Tamarac, Florida, 33321
Almirall Investigational Sites#894
Tampa, Florida, 33603
Almirall Investigational Sites#889
Tampa, Florida, 33613
Almirall Investigational Sites#924
Torrance, California, 90509
Almirall Investigational Sites#899
Tucson, Arizona, 85715
Almirall Investigational Sites#855
Tucson, Arizona, 85723
Almirall Investigational Sites#882
Walnut Creek, California, 94598
Almirall Investigational Sites#952
Waterbury, Connecticut, 06708
Almirall Investigational Sites#888
Wheat Ridge, Colorado, 80033
Almirall Investigational Sites#842
Williamston, North Carolina, 29697
Almirall Investigational Sites#915
Winston-Salem, North Carolina, 27103
Argentina13 sites
Almirall Investigational Sites#800
Buenos Aires, C1143ABH
Almirall Investigational Sites#744
Buenos Aires, C1221ADC
Almirall Investigational Sites#792
Buenos Aires, C1405DCS
Almirall Investigational Sites#793
Buenos Aires, C1416DVR
Almirall Investigational Sites#799
Buenos Aires, C1424BSF
Almirall Investigational Sites#795
Buenos Aires, C1425BEA
Almirall Investigational Sites#801
Buenos Aires, C1425DTG
Almirall Investigational Sites#791
Buenos Aires, C1426ABO
Almirall Investigational Sites#797
El Palomar, 1684
Almirall Investigational Sites#740
La Plata, 1900
Almirall Investigational Sites#801
Rosario, S2000DBS
Almirall Investigational Sites#796
San Miguel de Tucumán, 4000
Almirall Investigational Sites#794
Vicente López, 1602
Australia13 sites
Almirall Investigational Sites#807
Adelaide, 5061
Almirall Investigational Sites#834
Auchenflower, 2031
Almirall Investigational Sites#808
Bankstown, 2200
Almirall Investigational Sites#806
Boxhill, 3128
Almirall Investigational Sites#814
Cairns, 4870
Almirall Investigational Sites#813
Camperdown, 2050
Almirall Investigational Sites#811
Carina Heights, 4152
Almirall Investigational Sites#803
Clayton, 3168
Almirall Investigational Sites#809
Kippa-Ring, 4021
Almirall Investigational Sites#8121
Nedlands, 6009
Almirall Investigational Sites#812
Nedlands, 6009
Almirall Investigational Sites#805
Toorak Gardens, 5065
Almirall Investigational Sites#815
Woodville, 5011
South Africa9 sites
Almirall Investigational Sites#836
Bloemfontain, 9317
Almirall Investigational Sites#841
Bloemfontein, 9301
Almirall Investigational Sites#839
Cape Town, 7130
Almirall Investigational Sites#835
Cape Town, 7700
Almirall Investigational Sites#837
Cape Town, 7764
Almirall Investigational Sites#840
Cape Town, 8001
Almirall Investigational Sites#834
Durban, 4001
Almirall Investigational Sites#833
eManzimtoti, 4125
Almirall Investigational Sites#838
Johannesburg, 2193
Canada7 sites
Almirall Investigational Sites#823
Edmonton, T5X 4Z9
Almirall Investigational Sites#818
Kelowna, V1Y 9L8
Almirall Investigational Sites#822
Montreal, H4J 1C5
Almirall Investigational Sites#817
Niagara Falls, L2G 1J4
Almirall Investigational Sites#821
Ottawa, K1Y 4E9
Almirall Investigational Sites#935
Ottawa, K1Y 4G2
Almirall Investigational Sites#820
Toronto, Ontario, M6H 3M2
New Zealand3 sites
Almirall Investigational Sites#936
Auckland, 1640
Almirall Investigational Sites#830
Grafton, 1001
Almirall Investigational Sites#832
Tauranga, 3140
Mexico2 sites
Almirall Investigational Sites#827
Monterrey, 64460
Almirall Investigational Sites#826
Zapopan, 452000
About this study
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 by 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 by 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 FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks
Measured: 28 weeks
Trough FEV1 (L) at 12 Weeks on Treatment
Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks
Measured: 12 weeks
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: 52 weeks
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 posted31 Jul 2006 (estimated)
- Study startAug 2006
- Primary completionJun 2008
- Study completionJun 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
- 804 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
- NCT00358436
- Sponsor's protocol ID
- M/34273/31
- Other IDs
- ACCLAIM II, CT000742
- Status last verified
- Nov 2016
- First submitted
- 28 Jul 2006
- Last updated
- 4 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 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)
- ClinicalTrials.gov ID
- NCT00358436
- Acronym / sponsor ID
- M/34273/31
- Keywords
- COPD, Lung function, Exacerbations, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 804 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 31 Jul 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 by 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 by 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: 28 weeks
Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks
Trough FEV1 (L) at 12 Weeks on Treatment
Time frame: 12 weeks
Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured 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: 52 weeks
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 4 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.
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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
120 sites in 7 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 120 sites in 7 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 4 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 120 sites in United States, Argentina, Australia, South Africa, Canada and 2 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: 28 weeks). 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 NCT00358436, 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 4 Jan 2017.