Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo

PHASE2CompletedINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2010

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

Aclidinium 400 μg / Formoterol 12 μg

Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.

DRUG

Aclidinium 400 μg / Formoterol 6 μg

Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.

DRUG

Aclidinium 400 μg

Aclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods.

DRUG

Formoterol 12 μg

Formoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods.

DRUG

Placebo

Placebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods.

Trial Locations (20)

14901

Forest Investigative Site 1119, Elmira

27607

Forest Investigative Site 1153, Raleigh

27909

Forest Investigative Site 2035, Elizabeth City

29303

Forest Investigative Site 1121, Spartanburg

33603

Forest Investigative Site 2053, Tampa

33613

Forest Investigative Site 2047, Tampa

33765

Forest Investigative Site 1152, Clearwater

45242

Forest Investigative Site 2028, Cincinnati

76712

Forest Investigative Site 1129, Waco

78215

Forest Investigative Site 1498, San Antonio

80033

Forest Investigative Site 2045, Wheat Ridge

85006

Forest Investigative Site 2050, Pheonix

85306

Forest Investigative Site 0909, Glendale

92270

Forest Investigative Site 2029, Rancho Mirage

95207

Forest Investigative Site 1084, Stockton

97213

Forest Investigative Site 1106, Portland

97504

Forest Investigative Site 2043, Medford

02747

Forest Investigative Site 1431, North Dartmouth

07901

Forest Investigative Site 2084, Summit

02914

Forest Investigative Site 1089, East Providence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY