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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00706914
Other study ID # LAC-MD-24
Secondary ID
Status Terminated
Phase Phase 2
First received June 26, 2008
Last updated May 8, 2017
Start date June 30, 2008
Est. completion date November 11, 2008

Study information

Verified date April 2017
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 156
Est. completion date November 11, 2008
Est. primary completion date November 11, 2008
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Once-daily aclidinium/formoterol
Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning
Twice-daily formoterol fumarate
Inhaled formoterol fumarate 12 µg twice-daily (BID)
Placebo to formoterol fumarate
Inhaled placebo to formoterol fumarate once-daily in the evening
Once-daily formoterol fumarate
Inhaled formoterol fumarate 12 µg once-daily in the evening

Locations

Country Name City State
United States Forest Investigative Site Albany New York
United States Forest Investigative Site Atlanta Georgia
United States Forest Investigative Site Austell Georgia
United States Forest Investigative Site Blue Ridge Georgia
United States Forest Investigative Site Bowling Green Kentucky
United States Forest Investigative Site Charlotte North Carolina
United States Forest Investigative Site Cincinnati Ohio
United States Forest Investigative Site Columbus Ohio
United States Forest Investigative Site Dallas Texas
United States Forest Investigative Site DeLand Florida
United States Forest Investigative Site East Providence Rhode Island
United States Forest Investigative Site Florissant Missouri
United States Forest Investigative Site Fullerton California
United States Forest Investigative Site Hartford Connecticut
United States Forest Investigative Site Hazard Kentucky
United States Forest Investigative Site Lakewood California
United States Forest Investigative Site McKinney Texas
United States Forest Investigative Site Medford Oregon
United States Forest Investigative Site Midvale Utah
United States Forest Investigative Site Milwaukee Wisconsin
United States Forest Investigative Site New Britain Connecticut
United States Forest Investigative Site North Dartmouth Massachusetts
United States Forest Investigative Site Panama City Florida
United States Forest Investigative Site Pittsburgh Pennsylvania
United States Forest Investigative Site Rancho Mirage California
United States Forest Investigative Site Redlands California
United States Forest Investigative Site Richmond Virginia
United States Forest Investigative Site Rochester Minnesota
United States Forest Investigative Site Saint Charles Missouri
United States Forest Investigative Site Saint Louis Missouri
United States Forest Investigative Site San Diego California
United States Forest Investigative Site San Jose California
United States Forest Investigative Site Spartanburg South Carolina
United States Forest Investigative Site Stockton California
United States Forest Investigative Site Tamarac Florida
United States Forest Investigative Site Tampa Florida
United States Forest Investigative Site Tucson Arizona
United States Forest Investigative Site Tucson Arizona
United States Forest Investigative Site Waterbury Connecticut
United States Forest Investigative Site Wheat Ridge Colorado

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) The trough value for each pulmonary function parameter was defined as the mean of the two greatest readings assessed 23 hours and 24 hours following the administration of the morning dose of the previous day Week 4 of treatment
Other Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) Week 4 of treatment
Other Change From Baseline in Normalized Area Under the Curve (0-3 hr) of Forced Expiratory Volume in One Second (FEV1) FEV1 values obtained at 30, 60, 120, and 180 minutes after the morning study drug dose Week 4 of treatment
Primary Change From Baseline in Weekly Average Nocturnal Symptom Scores Nocturnal Symptom Score Scale: 0 = None; 1 = Symptoms causing early awakening or awakening once during the night; 2 = Symptoms causing early awakening or awakening two or more times during the night; 3 = Symptoms causing awakening for most time during the night, 4 = Symptoms which were so severe that I could not sleep at all Week 4 of treatment
Primary Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores Sputum Volume Score Scale: 0 = None; 1 = The amount of one teaspoon; 2 = The amount of one tablespoon; 3 = More than one tablespoon Week 4 of treatment
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