Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Seven Arm, Four-Period Cross-over, Incomplete Block Design, 7-Day Dosing Study to Assess the Dose-Response, Safety, and Efficacy of EP-101 (SUN101) in Subjects With Moderate to Severe COPD
NCT number | NCT01426009 |
Other study ID # | EP-101-03 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | August 2011 |
Est. completion date | December 2011 |
Verified date | May 2018 |
Source | Sunovion Respiratory Development Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine steady-state efficacy and dose response profile and to assess safety and pharmacokinetic profile of nebulized EP-101(SUN101) after 7-day dosing using an investigational high efficiency nebulizer (eFlow®) compared with placebo and two active comparators in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
Status | Completed |
Enrollment | 140 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 40-75 years of age - Clinical diagnosis of moderate to severe COPD - Current/ex-smokers with at least 10 pack-year smoking history - Post-bronchodilator FEV1 = 30% and = 70% predicted normal values - Post-bronchodilator FEV1/FVC ratio of = 0.70 - Post-bronchodilator improvement in FEV1 = 12% and = 30%, and a minimum of 100 mL - Willing and able to remain at the study site for at least 24 hours at each study visit - Signed written informed consent Exclusion Criteria: - Current evidence or recent history of any clinically significant and unstable disease or abnormality (e.g., myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes) - Primary diagnosis of asthma - History of malignancy within the past 5 years - History of COPD exacerbation within 6 weeks of Screening - Daily oxygen therapy > 10 hours per day - Systemic steroids use within 6 weeks of Screening - Respiratory tract infection within 6 weeks of Screening - History of tuberculosis, bronchiectasis - History of urinary retention or bladder neck obstruction type symptoms - History of glaucoma - Prolonged QTc interval (>460msec) or history of long QT syndrome - Recent history of alcohol or drug abuse - Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable birth control methods - History of hypersensitivity or intolerance to aerosol medications - Participation in another investigational drug study within 30 days of Screening |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Elevation Investigational Site | Manchester | |
United States | Elevation Investigational Site | Charlotte | North Carolina |
United States | Elevation Investigational Site | DeLand | Florida |
United States | Elevation Investigational Site | Los Angeles | California |
United States | Elevation Investigational SIte | Madisonville | Kentucky |
United States | Elevation Investigational Site | Medford | Oregon |
United States | Elevation Investigational Site | North Dartmouth | Massachusetts |
United States | Elevation Investigational Site | Phoenix | Arizona |
United States | Elevation Investigational Site | Raleigh | North Carolina |
United States | Elevation Investigational Site | Spartanburg | South Carolina |
United States | Elevation Investigational Site | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
Sunovion Respiratory Development Inc. |
United States, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Change in 24 Post Dose Trough Forced Expiratory Volume in 1 Second (FEV1) | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the mean of the spirometry values collected at 23 hours 30 minutes and 24 hours post dose for Day 1 and Day 7 within each Treatment Period. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period. Change from baseline was calculated as the trough FEV1 value minus the baseline for Day 1 and Day 7. | Day 1 and Day 7 | |
Primary | Standardized Change in FEV1 Area Under the Curve (AUC) (0-12hr , 12-24hr, 0-24hr) on Day 1 and Day 7 | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. The standardized FEV1 AUC(0-12hr and 12-24hr) on Day 1 and Day 7 was calculated using the trapezoidal rule from the changes in FEV1 at Day 1 and Day 7, respectively, from the baseline value (the mean of the two FEV1 values at 45 minutes and 15 minutes prior to morning dose at Day 1 of the respective Treatment Periods) and dividing by the actual length of the time interval. | Day 1 and Day 7 | |
Secondary | Peak FEV1 (Maximum FEV1 During the First 4 Hours Post-dose on Day 1 and Day 7) | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines | Day 1 and Day 7 | |
Secondary | Treatment Responders (Number of Subjects With Clinically Meaningful Change From Pre-dose in Trough FEV1 on Day 1 and Day 7) | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Clinically meaningful is defined as when the change from baseline (mean of the two pre-dose values at Day 1) in 24 hour trough FEV1 on a SUN-101 treatment is more than 100 mL compared to the mean change in trough FEV1 from all subjects on the placebo treatment. | Day 1 and Day 7 | |
Secondary | Number of Participants With Adverse Events, Vital Signs, and Clinically Significant Abnormal ECG Values and Laboratory Tests | AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. Vital signs were performed during the screening period to confirm study eligibility and at the final study visit. ECGs were performed during the screening period to confirm study eligibility. Vital signs and ECG were additionally collected within 30 minutes pre-dose; and 30 minutes, and 1, 2, 4, 6, 12 hours, and 23 hours 45 minutes post-dose within each treatment period. Clinical laboratory assessments were conducted during the screening period, at each study visit during each treatment period, and at the final study visit. | Day 1 through Day 7 | |
Secondary | Rescue Medication Use | Mean number of puffs of daily rescue medication | Day 1 through Day 7 | |
Secondary | Treatment Responders (Percentage of Subjects With Clinically Meaningful Change From Pre-dose in Trough FEV1 on Day 1 and Day 7) | percentage of subjects with clinically meaningful change from pre-dose in trough FEV1 on Day 1 and Day 7 Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. | Day 1 and Day 7 |
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