Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: Placebo
- Registration Number
- NCT00358436
- 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
- 804
- 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 by inhalation
- Primary Outcome Measures
Name Time Method Trough FEV1 (L) at 28 Weeks on Treatment 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 12 weeks Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured 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 52 weeks 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 (118)
Almirall Investigational Sites#930
🇺🇸Los Angeles, California, United States
Almirall Investigational Sites#922
🇺🇸Los Angeles, California, United States
Almirall Investigational Sites#902
🇺🇸Riverside, California, United States
Almirall Investigational Sites#924
🇺🇸Torrance, California, United States
Almirall Investigational Sites#849
🇺🇸Marietta, Georgia, United States
Almirall Investigational Sites#906
🇺🇸Butte, Montana, United States
Almirall Investigational Sites#933
🇺🇸Chicago, Illinois, United States
Almirall Investigational Sites#850
🇺🇸San Diego, California, United States
Almirall Investigational Sites#897
🇺🇸San Diego, California, United States
Almirall Investigational Sites#870
🇺🇸Cincinnati, Ohio, United States
Almirall Investigational Sites#926
🇺🇸Jasper, Alabama, United States
Almirall Investigational Sites#858
🇺🇸Ozark, Alabama, United States
Almirall Investigational Sites#904
🇺🇸Encinitas, California, United States
Almirall Investigational Sites#879
🇺🇸Little Rock, Arkansas, United States
Almirall Investigational Sites#932
🇺🇸Carmichael, California, United States
Almirall Investigational Sites#903
🇺🇸Fullerton, California, United States
Almirall Investigational Sites#871
🇺🇸Rancho Mirage, California, United States
Almirall Investigational Sites#893
🇺🇸North Hills, California, United States
Almirall Investigational Sites#882
🇺🇸Walnut Creek, California, United States
Almirall Investigational Sites#888
🇺🇸Wheat Ridge, Colorado, United States
Almirall Investigational Sites#880
🇺🇸Fort Collins, Colorado, United States
Almirall Investigational Sites#952
🇺🇸Waterbury, Connecticut, United States
Almirall Investigational Sites#844
🇺🇸Bay Pines, Florida, United States
Almirall Investigational Sites#863
🇺🇸Clearwater, Florida, United States
Almirall Investigational Sites#152
🇺🇸Deland, Florida, United States
Almirall Investigational Sites#8533
🇺🇸Melbourne, Florida, United States
Almirall Investigational Sites#920
🇺🇸Tamarac, Florida, United States
Almirall Investigational Sites#894
🇺🇸Tampa, Florida, United States
Almirall Investigational Sites#889
🇺🇸Tampa, Florida, United States
Almirall Investigational Sites#890
🇺🇸Atlanta, Georgia, United States
Almirall Investigational Sites#907
🇺🇸Decatur, Georgia, United States
Almirall Investigational Sites#931
🇺🇸Gainesville, Georgia, United States
Almirall Investigational Sites#872
🇺🇸Hines, Illinois, United States
Almirall Investigational Sites#892
🇺🇸River Forest, Illinois, United States
Almirall Investigational Sites#864
🇺🇸Evansville, Indiana, United States
Almirall Investigational Sites#923
🇺🇸Florence, Kentucky, United States
Almirall Investigational Sites#876
🇺🇸Bowling Green, Kentucky, United States
Almirall Investigational Sites#866
🇺🇸Lafayette, Louisiana, United States
Almirall Investigational Sites#976
🇺🇸Lewiston, Maine, United States
Almirall Investigational Sites#911
🇺🇸Shreveport, Louisiana, United States
Almirall Investigational Sites#843
🇺🇸Baltimore, Maryland, United States
Almirall Investigational Sites#846
🇺🇸Cherry Hill, New Jersey, United States
Almirall Investigational Sites#883
🇺🇸Biddeford, Maine, United States
Almirall Investigational Sites#868
🇺🇸Cadillac, Michigan, United States
Almirall Investigational Sites#916
🇺🇸Saint Charles, Missouri, United States
Almirall Investigational Sites#885
🇺🇸Newark, New Jersey, United States
Almirall Investigational Sites#921
🇺🇸Summit, New Jersey, United States
Almirall Investigational Sites#896
🇺🇸Albuquerque, New Mexico, United States
Almirall Investigational Sites#919
🇺🇸Charlotte, North Carolina, United States
Almirall Investigational Sites#861
🇺🇸Chapel Hill, North Carolina, United States
Almirall Investigational Sites#915
🇺🇸Winston Salem, North Carolina, United States
Almirall Investigational Sites#878
🇺🇸Elizabeth City, North Carolina, United States
Almirall Investigational Sites#842
🇺🇸Williamston, North Carolina, United States
Almirall Investigational Sites#848
🇺🇸Cincinatti, Ohio, United States
Almirall Investigational Sites#847
🇺🇸Columbus, Ohio, United States
Almirall Investigational Sites#928
🇺🇸Sylvania, Ohio, United States
Almirall Investigational Sites#905
🇺🇸Eugene, Oregon, United States
Almirall Investigational Sites#860
🇺🇸Medford, Oregon, United States
Almirall Investigational Sites#886
🇺🇸Medford, Oregon, United States
Almirall Investigational Sites#918
🇺🇸Greer, South Carolina, United States
Almirall Investigational Sites#898
🇺🇸Dallas, Texas, United States
Almirall Investigational Sites#875
🇺🇸Houston, Texas, United States
Almirall Investigational Sites#854
🇺🇸Fort Worth, Texas, United States
Almirall Investigational Sites#951
🇺🇸Richmond, Virginia, United States
Almirall Investigational Sites#744
🇦🇷Buenos Aires, Argentina
Almirall Investigational Sites#792
🇦🇷Buenos Aires, Argentina
Almirall Investigational Sites#793
🇦🇷Buenos Aires, Argentina
Almirall Investigational Sites#799
🇦🇷Buenos Aires, Argentina
Almirall Investigational Sites#801
🇦🇷Rosario, Argentina
Almirall Investigational Sites#791
🇦🇷Buenos Aires, Argentina
Almirall Investigational Sites#797
🇦🇷El Palomar, Argentina
Almirall Investigational Sites#740
🇦🇷La Plata, Argentina
Almirall Investigational Sites#794
🇦🇷Vicente López, Argentina
Almirall Investigational Sites#834
🇿🇦Durban, South Africa
Almirall Investigational Sites#796
🇦🇷San Miguel de Tucuman, Argentina
Almirall Investigational Sites#807
🇦🇺Adelaide, Australia
Almirall Investigational Sites#808
🇦🇺Bankstown, Australia
Almirall Investigational Sites#806
🇦🇺Boxhill, Australia
Almirall Investigational Sites#814
🇦🇺Cairns, Australia
Almirall Investigational Sites#813
🇦🇺Camperdown, Australia
Almirall Investigational Sites#811
🇦🇺Carina Heights, Australia
Almirall Investigational Sites#803
🇦🇺Clayton, Australia
Almirall Investigational Sites#809
🇦🇺Kippa Ring, Australia
Almirall Investigational Sites#812
🇦🇺Nedlands, Australia
Almirall Investigational Sites#805
🇦🇺Toorak Gardens, Australia
Almirall Investigational Sites#8121
🇦🇺Nedlands, Australia
Almirall Investigational Sites#815
🇦🇺Woodville, Australia
Almirall Investigational Sites#823
🇨🇦Edmonton, Canada
Almirall Investigational Sites#817
🇨🇦Niagara Falls, Canada
Almirall Investigational Sites#822
🇨🇦Montreal, Canada
Almirall Investigational Sites#818
🇨🇦Kelowna, Canada
Almirall Investigational Sites#821
🇨🇦Ottawa, Canada
Almirall Investigational Sites#935
🇨🇦Ottawa, Canada
Almirall Investigational Sites#820
🇨🇦Toronto, Ontario, Canada
Almirall Investigational Sites#827
🇲🇽Monterrey, Mexico
Almirall Investigational Sites#936
🇳🇿Auckland, New Zealand
Almirall Investigational Sites#830
🇳🇿Grafton, New Zealand
Almirall Investigational Sites#832
🇳🇿Tauranga, New Zealand
Almirall Investigational Sites#836
🇿🇦Bloemfontain, South Africa
Almirall Investigational Sites#841
🇿🇦Bloemfontein, South Africa
Almirall Investigational Sites#833
🇿🇦Amanzimtoti, South Africa
Almirall Investigational Sites#839
🇿🇦Cape Town, South Africa
Almirall Investigational Sites#835
🇿🇦Cape Town, South Africa
Almirall Investigational Sites#837
🇿🇦Cape Town, South Africa
Almirall Investigational Sites#884
🇺🇸Minneapolis, Minnesota, United States
Almirall Investigational Sites#881
🇺🇸San Antonio, Texas, United States
Almirall Investigational Sites#899
🇺🇸Tucson, Arizona, United States
Almirall Investigational Sites#910
🇺🇸Charleston, South Carolina, United States
Almirall Investigational Sites#800
🇦🇷Buenos Aires, Argentina
Almirall Investigational Sites#826
🇲🇽Zapopan, Mexico
Almirall Investigational Sites#855
🇺🇸Tucson, Arizona, United States
Almirall Investigational Sites#900
🇺🇸Phoenix, Arizona, United States
Almirall Investigational Sites#795
🇦🇷Buenos Aires, Argentina
Almirall Investigational Sites#895
🇺🇸Denver, Colorado, United States
Almirall Investigational Sites#909
🇺🇸Omaha, Nebraska, United States
Almirall Investigational Sites#856
🇺🇸Milwaukee, Wisconsin, United States
Almirall Investigational Sites#838
🇿🇦Johannesburg, South Africa
Almirall Investigational Sites#840
🇿🇦Cape Town, South Africa