Clinical trial NCT00706914: Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter, 4-Week Pilot Study to Assess Symptoms in Stable, Moderate to Severe COPD Patients Taking Aclidinium Bromide 200 mcg Once Daily in Combination With Formoterol Fumarate Once or Twice Daily Versus Formoterol Fumarate Twice Daily
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Airflow Obstruction, Chronic
Chronic Airflow Obstruction
Chronic Obstructive Pulmonary Disease
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease
COPD
COAD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-30
Enrollment: 156
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs. formoterol fumarate twice daily. The study will assess pulmonary function and symptoms in patients with moderate to severe COPD.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe COPD
* Smoking history of greater or equal to 10 pack-years
* Diagnosis of stable moderate to severe COPD as defined by the GOLD Guidelines
* Postbronchodilator FEV1 from 30% to 79% of predicted values, inclusive
* Postbronchodilator FEV1/FVC ratio \< 0.70

Exclusion Criteria:

* History or presence of asthma, allergic rhinitis, or exercise-induced bronchospasm
* Hospitalization for an acute COPD exacerbation in the 3 months prior to study entry
* Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
* Eosinophil count of at least 600 cells/mm3
* Long term oxygen therapy \> 15 hours a day

Primary outcomes:
measure: Change From Baseline in Weekly Average Nocturnal Symptom Scores
timeFrame: Week 4 of treatment
measure: Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores
timeFrame: Week 4 of treatment
Secondary outcomes:
Other outcomes:
measure: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)
timeFrame: Week 4 of treatment
measure: Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
timeFrame: Week 4 of treatment
measure: Change From Baseline in Normalized Area Under the Curve (0-3 hr) of Forced Expiratory Volume in One Second (FEV1)
timeFrame: Week 4 of treatment
Locations:
city: Tucson
country: United States
facility: Forest Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Forest Investigative Site
state: Arizona
city: Fullerton
country: United States
facility: Forest Investigative Site
state: California
city: Lakewood
country: United States
facility: Forest Investigative Site
state: California
city: Rancho Mirage
country: United States
facility: Forest Investigative Site
state: California
city: Redlands
country: United States
facility: Forest Investigative Site
state: California
city: San Diego
country: United States
facility: Forest Investigative Site
state: California
city: San Jose
country: United States
facility: Forest Investigative Site
state: California
city: Stockton
country: United States
facility: Forest Investigative Site
state: California
city: Wheat Ridge
country: United States
facility: Forest Investigative Site
state: Colorado
city: Hartford
country: United States
facility: Forest Investigative Site
state: Connecticut
city: New Britain
country: United States
facility: Forest Investigative Site
state: Connecticut
city: Waterbury
country: United States
facility: Forest Investigative Site
state: Connecticut
city: DeLand
country: United States
facility: Forest Investigative Site
state: Florida
city: Panama City
country: United States
facility: Forest Investigative Site
state: Florida
city: Tamarac
country: United States
facility: Forest Investigative Site
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site
state: Georgia
city: Austell
country: United States
facility: Forest Investigative Site
state: Georgia
city: Blue Ridge
country: United States
facility: Forest Investigative Site
state: Georgia
city: Bowling Green
country: United States
facility: Forest Investigative Site
state: Kentucky
city: Hazard
country: United States
facility: Forest Investigative Site
state: Kentucky
city: North Dartmouth
country: United States
facility: Forest Investigative Site
state: Massachusetts
city: Rochester
country: United States
facility: Forest Investigative Site
state: Minnesota
city: Florissant
country: United States
facility: Forest Investigative Site
state: Missouri
city: Saint Charles
country: United States
facility: Forest Investigative Site
state: Missouri
city: Saint Louis
country: United States
facility: Forest Investigative Site
state: Missouri
city: Albany
country: United States
facility: Forest Investigative Site
state: New York
city: Charlotte
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Forest Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site
state: Ohio
city: Medford
country: United States
facility: Forest Investigative Site
state: Oregon
city: Pittsburgh
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: East Providence
country: United States
facility: Forest Investigative Site
state: Rhode Island
city: Spartanburg
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Dallas
country: United States
facility: Forest Investigative Site
state: Texas
city: McKinney
country: United States
facility: Forest Investigative Site
state: Texas
city: Midvale
country: United States
facility: Forest Investigative Site
state: Utah
city: Richmond
country: United States
facility: Forest Investigative Site
state: Virginia
city: Milwaukee
country: United States
facility: Forest Investigative Site
state: Wisconsin
Study officials:
affiliation: AstraZeneca
name: Esther Garcia, MD
role: STUDY_DIRECTOR
References: