Pulmonary Disease, Chronic Obstructive Clinical Trial
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
| Verified date | April 2017 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| 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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