Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)
3 other identifiers
interventional
804
7 countries
120
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2006
120 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2006
CompletedFirst Posted
Study publicly available on registry
July 31, 2006
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
November 1, 2012
CompletedJanuary 4, 2017
November 1, 2016
1.8 years
July 28, 2006
August 14, 2012
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
12 weeks
Secondary Outcomes (2)
Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment
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
52 weeks
Study Arms (2)
Aclidinium 200 μg once-daily
EXPERIMENTALAclidinium bromide 200 μg once-daily by inhalation
Placebo
PLACEBO COMPARATORPlacebo by inhalation
Interventions
Aclidinium bromide 200 μg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks
Eligibility Criteria
You may qualify if:
- Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (120)
Almirall Investigational Sites#926
Jasper, Alabama, 35501, United States
Almirall Investigational Sites#858
Ozark, Alabama, 36360, United States
Almirall Investigational Sites#900
Phoenix, Arizona, 85023, United States
Almirall Investigational Sites#899
Tucson, Arizona, 85715, United States
Almirall Investigational Sites#855
Tucson, Arizona, 85723, United States
Almirall Investigational Sites#879
Little Rock, Arkansas, 72205-7199, United States
Almirall Investigational Sites#932
Carmichael, California, 95837, United States
Almirall Investigational Sites#904
Encinitas, California, 92024, United States
Almirall Investigational Sites#903
Fullerton, California, 92835, United States
Almirall Investigational Sites#930
Los Angeles, California, 90048, United States
Almirall Investigational Sites#922
Los Angeles, California, 90095-1690, United States
Almirall Investigational Sites#893
North Hills, California, 91343, United States
Almirall Investigational Sites#871
Rancho Mirage, California, 92270, United States
Almirall Investigational Sites#902
Riverside, California, 92506, United States
Almirall Investigational Sites#850
San Diego, California, 92120, United States
Almirall Investigational Sites#897
San Diego, California, 92120, United States
Almirall Investigational Sites#924
Torrance, California, 90509, United States
Almirall Investigational Sites#882
Walnut Creek, California, 94598, United States
Almirall Investigational Sites#895
Denver, Colorado, 80206, United States
Almirall Investigational Sites#880
Fort Collins, Colorado, 80528, United States
Almirall Investigational Sites#888
Wheat Ridge, Colorado, 80033, United States
Almirall Investigational Sites#952
Waterbury, Connecticut, 06708, United States
Almirall Investigational Sites#844
Bay Pines, Florida, 33744, United States
Almirall Investigational Sites#863
Clearwater, Florida, 33765, United States
Almirall Investigational Sites#152
DeLand, Florida, 32720, United States
Almirall Investigational Sites#8533
Melbourne, Florida, 32935, United States
Almirall Investigational Sites#920
Tamarac, Florida, 33321, United States
Almirall Investigational Sites#894
Tampa, Florida, 33603, United States
Almirall Investigational Sites#889
Tampa, Florida, 33613, United States
Almirall Investigational Sites#890
Atlanta, Georgia, 30309, United States
Almirall Investigational Sites#907
Decatur, Georgia, 30033, United States
Almirall Investigational Sites#931
Gainesville, Georgia, 30501, United States
Almirall Investigational Sites#849
Marietta, Georgia, 30060, United States
Almirall Investigational Sites#933
Chicago, Illinois, 60612, United States
Almirall Investigational Sites#872
Hines, Illinois, 60141, United States
Almirall Investigational Sites#892
River Forest, Illinois, 60305, United States
Almirall Investigational Sites#864
Evansville, Indiana, 47714, United States
Almirall Investigational Sites#876
Bowling Green, Kentucky, 42101, United States
Almirall Investigational Sites#923
Florence, Kentucky, 41042, United States
Almirall Investigational Sites#866
Lafayette, Louisiana, 70503, United States
Almirall Investigational Sites#911
Shreveport, Louisiana, 71103, United States
Almirall Investigational Sites#883
Biddeford, Maine, 04005, United States
Almirall Investigational Sites#976
Lewiston, Maine, 04240, United States
Almirall Investigational Sites#843
Baltimore, Maryland, 21201, United States
Almirall Investigational Sites#868
Cadillac, Michigan, 49601, United States
Almirall Investigational Sites#884
Minneapolis, Minnesota, 55402, United States
Almirall Investigational Sites#916
Saint Charles, Missouri, 63301, United States
Almirall Investigational Sites#906
Butte, Montana, 59701, United States
Almirall Investigational Sites#909
Omaha, Nebraska, 68198-2465, United States
Almirall Investigational Sites#846
Cherry Hill, New Jersey, 08003, United States
Almirall Investigational Sites#885
Newark, New Jersey, 07112, United States
Almirall Investigational Sites#921
Summit, New Jersey, 07901, United States
Almirall Investigational Sites#896
Albuquerque, New Mexico, 87108, United States
Almirall Investigational Sites#861
Chapel Hill, North Carolina, 27599, United States
Almirall Investigational Sites#919
Charlotte, North Carolina, 28207, United States
Almirall Investigational Sites#878
Elizabeth City, North Carolina, 27909, United States
Almirall Investigational Sites#842
Williamston, North Carolina, 29697, United States
Almirall Investigational Sites#915
Winston-Salem, North Carolina, 27103, United States
Almirall Investigational Sites#848
Cincinnati, Ohio, 45231, United States
Almirall Investigational Sites#870
Cincinnati, Ohio, 45242, United States
Almirall Investigational Sites#847
Columbus, Ohio, 43215, United States
Almirall Investigational Sites#928
Sylvania, Ohio, 43560, United States
Almirall Investigational Sites#905
Eugene, Oregon, 97401, United States
Almirall Investigational Sites#860
Medford, Oregon, 97504, United States
Almirall Investigational Sites#886
Medford, Oregon, 97504, United States
Almirall Investigational Sites#910
Charleston, South Carolina, 29406, United States
Almirall Investigational Sites#918
Greer, South Carolina, 29651, United States
Almirall Investigational Sites#898
Dallas, Texas, 75246, United States
Almirall Investigational Sites#854
Fort Worth, Texas, 76104, United States
Almirall Investigational Sites#875
Houston, Texas, 77030, United States
Almirall Investigational Sites#881
San Antonio, Texas, 78229, United States
Almirall Investigational Sites#951
Richmond, Virginia, 23225, United States
Almirall Investigational Sites#856
Milwaukee, Wisconsin, 53209, United States
Almirall Investigational Sites#800
Buenos Aires, C1143ABH, Argentina
Almirall Investigational Sites#744
Buenos Aires, C1221ADC, Argentina
Almirall Investigational Sites#792
Buenos Aires, C1405DCS, Argentina
Almirall Investigational Sites#793
Buenos Aires, C1416DVR, Argentina
Almirall Investigational Sites#799
Buenos Aires, C1424BSF, Argentina
Almirall Investigational Sites#795
Buenos Aires, C1425BEA, Argentina
Almirall Investigational Sites#801
Buenos Aires, C1425DTG, Argentina
Almirall Investigational Sites#791
Buenos Aires, C1426ABO, Argentina
Almirall Investigational Sites#797
El Palomar, 1684, Argentina
Almirall Investigational Sites#740
La Plata, 1900, Argentina
Almirall Investigational Sites#801
Rosario, S2000DBS, Argentina
Almirall Investigational Sites#796
San Miguel de Tucumán, 4000, Argentina
Almirall Investigational Sites#794
Vicente López, 1602, Argentina
Almirall Investigational Sites#807
Adelaide, 5061, Australia
Almirall Investigational Sites#834
Auchenflower, 2031, Australia
Almirall Investigational Sites#808
Bankstown, 2200, Australia
Almirall Investigational Sites#806
Boxhill, 3128, Australia
Almirall Investigational Sites#814
Cairns, 4870, Australia
Almirall Investigational Sites#813
Camperdown, 2050, Australia
Almirall Investigational Sites#811
Carina Heights, 4152, Australia
Almirall Investigational Sites#803
Clayton, 3168, Australia
Almirall Investigational Sites#809
Kippa-Ring, 4021, Australia
Almirall Investigational Sites#8121
Nedlands, 6009, Australia
Almirall Investigational Sites#812
Nedlands, 6009, Australia
Almirall Investigational Sites#805
Toorak Gardens, 5065, Australia
Almirall Investigational Sites#815
Woodville, 5011, Australia
Almirall Investigational Sites#823
Edmonton, T5X 4Z9, Canada
Almirall Investigational Sites#818
Kelowna, V1Y 9L8, Canada
Almirall Investigational Sites#822
Montreal, H4J 1C5, Canada
Almirall Investigational Sites#817
Niagara Falls, L2G 1J4, Canada
Almirall Investigational Sites#821
Ottawa, K1Y 4E9, Canada
Almirall Investigational Sites#935
Ottawa, K1Y 4G2, Canada
Almirall Investigational Sites#820
Toronto, Ontario, M6H 3M2, Canada
Almirall Investigational Sites#827
Monterrey, 64460, Mexico
Almirall Investigational Sites#826
Zapopan, 452000, Mexico
Almirall Investigational Sites#936
Auckland, 1640, New Zealand
Almirall Investigational Sites#830
Grafton, 1001, New Zealand
Almirall Investigational Sites#832
Tauranga, 3140, New Zealand
Almirall Investigational Sites#836
Bloemfontain, 9317, South Africa
Almirall Investigational Sites#841
Bloemfontein, 9301, South Africa
Almirall Investigational Sites#839
Cape Town, 7130, South Africa
Almirall Investigational Sites#835
Cape Town, 7700, South Africa
Almirall Investigational Sites#837
Cape Town, 7764, South Africa
Almirall Investigational Sites#840
Cape Town, 8001, South Africa
Almirall Investigational Sites#834
Durban, 4001, South Africa
Almirall Investigational Sites#833
eManzimtoti, 4125, South Africa
Almirall Investigational Sites#838
Johannesburg, 2193, South Africa
Related Publications (1)
Jones 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.
PMID: 21518460DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- AstraZeneca Clinical
- Organization
- Study Information Center
Study Officials
- STUDY DIRECTOR
Esther Garcia, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2006
First Posted
July 31, 2006
Study Start
August 1, 2006
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
January 4, 2017
Results First Posted
November 1, 2012
Record last verified: 2016-11