Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358436
• Other study ID #: CT000742
• Secondary ID: ACCLAIM IIM/3427
• Status: Completed
• Phase: Phase 3
• First received: July 28, 2006
• Last updated: May 28, 2015
• Start date: July 2006
• Est. completion date: June 2008

Study information

• 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

Clinical 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Aclidinium bromide
Aclidinium bromide 200 µg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks
• Placebo
Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Almirall, S.A.	Forest Laboratories

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Mexico,  New Zealand,  South Africa, 

Outcome

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

External Links

•   Co-Sponsor web site
•   Sponsor web site