Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Verified date | May 2015 |
Source | Almirall, S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.
Status | Completed |
Enrollment | 804 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Almirall Investigational Sites#744 | Buenos Aires | |
Argentina | Almirall Investigational Sites#791 | Buenos Aires | |
Argentina | Almirall Investigational Sites#792 | Buenos Aires | |
Argentina | Almirall Investigational Sites#793 | Buenos Aires | |
Argentina | Almirall Investigational Sites#795 | Buenos Aires | |
Argentina | Almirall Investigational Sites#799 | Buenos Aires | |
Argentina | Almirall Investigational Sites#800 | Buenos Aires | |
Argentina | Almirall Investigational Sites#801 | Buenos Aires | |
Argentina | Almirall Investigational Sites#797 | El Palomar | |
Argentina | Almirall Investigational Sites#740 | La Plata | |
Argentina | Almirall Investigational Sites#801 | Rosario | |
Argentina | Almirall Investigational Sites#796 | San Miguel de Tucuman | |
Argentina | Almirall Investigational Sites#794 | Vicente López | |
Australia | Almirall Investigational Sites#807 | Adelaide | |
Australia | Almirall Investigational Sites#834 | Auchenflower | |
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#8121 | Nedlands | |
Australia | Almirall Investigational Sites#805 | Toorak Gardens | |
Australia | Almirall Investigational Sites#815 | Woodville | |
Canada | Almirall Investigational Sites#823 | Edmonton | |
Canada | Almirall Investigational Sites#818 | Kelowna | |
Canada | Almirall Investigational Sites#822 | Montreal | |
Canada | Almirall Investigational Sites#817 | Niagara Falls | |
Canada | Almirall Investigational Sites#821 | Ottawa | |
Canada | Almirall Investigational Sites#935 | Ottawa | |
Canada | Almirall Investigational Sites#820 | Toronto, Ontario | |
Mexico | Almirall Investigational Sites#827 | Monterrey | |
Mexico | Almirall Investigational Sites#826 | Zapopan | |
New Zealand | Almirall Investigational Sites#936 | Auckland | |
New Zealand | Almirall Investigational Sites#830 | Grafton | |
New Zealand | Almirall Investigational Sites#832 | Tauranga | |
South Africa | Almirall Investigational Sites#833 | Amanzimtoti | |
South Africa | Almirall Investigational Sites#836 | Bloemfontain | |
South Africa | Almirall Investigational Sites#841 | Bloemfontein | |
South Africa | Almirall Investigational Sites#835 | Cape Town | |
South Africa | Almirall Investigational Sites#837 | Cape Town | |
South Africa | Almirall Investigational Sites#839 | Cape Town | |
South Africa | Almirall Investigational Sites#840 | Cape Town | |
South Africa | Almirall Investigational Sites#834 | Durban | |
South Africa | Almirall Investigational Sites#838 | Johannesburg | |
United States | Almirall Investigational Sites#896 | Albuquerque | New Mexico |
United States | Almirall Investigational Sites#890 | Atlanta | Georgia |
United States | Almirall Investigational Sites#843 | Baltimore | Maryland |
United States | Almirall Investigational Sites#844 | Bay Pines | Florida |
United States | Almirall Investigational Sites#883 | Biddeford | Maine |
United States | Almirall Investigational Sites#876 | Bowling Green | Kentucky |
United States | Almirall Investigational Sites#906 | Butte | Montana |
United States | Almirall Investigational Sites#868 | Cadillac | Michigan |
United States | Almirall Investigational Sites#932 | Carmichael | California |
United States | Almirall Investigational Sites#861 | Chapel Hill | North Carolina |
United States | Almirall Investigational Sites#910 | Charleston | South Carolina |
United States | Almirall Investigational Sites#919 | Charlotte | North Carolina |
United States | Almirall Investigational Sites#846 | Cherry Hill | New Jersey |
United States | Almirall Investigational Sites#933 | Chicago | Illinois |
United States | Almirall Investigational Sites#848 | Cincinatti | Ohio |
United States | Almirall Investigational Sites#870 | Cincinnati | Ohio |
United States | Almirall Investigational Sites#863 | Clearwater | Florida |
United States | Almirall Investigational Sites#847 | Columbus | Ohio |
United States | Almirall Investigational Sites#898 | Dallas | Texas |
United States | Almirall Investigational Sites#907 | Decatur | Georgia |
United States | Almirall Investigational Sites#152 | Deland | Florida |
United States | Almirall Investigational Sites#895 | Denver | Colorado |
United States | Almirall Investigational Sites#878 | Elizabeth City | North Carolina |
United States | Almirall Investigational Sites#904 | Encinitas | California |
United States | Almirall Investigational Sites#905 | Eugene | Oregon |
United States | Almirall Investigational Sites#864 | Evansville | Indiana |
United States | Almirall Investigational Sites#923 | Florence | Kentucky |
United States | Almirall Investigational Sites#880 | Fort Collins | Colorado |
United States | Almirall Investigational Sites#854 | Fort Worth | Texas |
United States | Almirall Investigational Sites#903 | Fullerton | California |
United States | Almirall Investigational Sites#931 | Gainesville | Georgia |
United States | Almirall Investigational Sites#918 | Greer | South Carolina |
United States | Almirall Investigational Sites#872 | Hines | Illinois |
United States | Almirall Investigational Sites#875 | Houston | Texas |
United States | Almirall Investigational Sites#926 | Jasper | Alabama |
United States | Almirall Investigational Sites#866 | Lafayette | Louisiana |
United States | Almirall Investigational Sites#976 | Lewiston | Maine |
United States | Almirall Investigational Sites#879 | Little Rock | Arkansas |
United States | Almirall Investigational Sites#922 | Los Angeles | California |
United States | Almirall Investigational Sites#930 | Los Angeles | California |
United States | Almirall Investigational Sites#849 | Marietta | Georgia |
United States | Almirall Investigational Sites#860 | Medford | Oregon |
United States | Almirall Investigational Sites#886 | Medford | Oregon |
United States | Almirall Investigational Sites#8533 | Melbourne | Florida |
United States | Almirall Investigational Sites#856 | Milwaukee | Wisconsin |
United States | Almirall Investigational Sites#884 | Minneapolis | Minnesota |
United States | Almirall Investigational Sites#885 | Newark | New Jersey |
United States | Almirall Investigational Sites#893 | North Hills | California |
United States | Almirall Investigational Sites#909 | Omaha | Nebraska |
United States | Almirall Investigational Sites#858 | Ozark | Alabama |
United States | Almirall Investigational Sites#900 | Phoenix | Arizona |
United States | Almirall Investigational Sites#871 | Rancho Mirage | California |
United States | Almirall Investigational Sites#951 | Richmond | Virginia |
United States | Almirall Investigational Sites#892 | River Forest | Illinois |
United States | Almirall Investigational Sites#902 | Riverside | California |
United States | Almirall Investigational Sites#881 | San Antonio | Texas |
United States | Almirall Investigational Sites#850 | San Diego | California |
United States | Almirall Investigational Sites#897 | San Diego | California |
United States | Almirall Investigational Sites#911 | Shreveport | Louisiana |
United States | Almirall Investigational Sites#916 | St. Charles | Missouri |
United States | Almirall Investigational Sites#921 | Summit | New Jersey |
United States | Almirall Investigational Sites#928 | Sylvania | Ohio |
United States | Almirall Investigational Sites#920 | Tamarac | Florida |
United States | Almirall Investigational Sites#889 | Tampa | Florida |
United States | Almirall Investigational Sites#894 | Tampa | Florida |
United States | Almirall Investigational Sites#924 | Torrance | California |
United States | Almirall Investigational Sites#855 | Tucson | Arizona |
United States | Almirall Investigational Sites#899 | Tucson | Arizona |
United States | Almirall Investigational Sites#882 | Walnut Creek | California |
United States | Almirall Investigational Sites#952 | Waterbury | Connecticut |
United States | Almirall Investigational Sites#888 | Wheat Ridge | Colorado |
United States | Almirall Investigational Sites#842 | Williamston | North Carolina |
United States | Almirall Investigational Sites#915 | Winston Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Almirall, S.A. | Forest Laboratories |
United States, Argentina, Australia, Canada, Mexico, New Zealand, South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | 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. |
52 weeks | No |
Secondary | 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 | 52 weeks | No |
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