Chronic Obstructive Pulmonary Disease (COPD). MedDRA version: 13.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Glycopyrrolate inhalation solution, 25mcg
Product Code: EP-101
Pharmaceutical Form: Nebuliser solution
CAS Number: 596-51-0
Current Sponsor code: Glycopyrrolate
Other descriptive name: G
Sponsors
Elevation Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects age 40 through 75 years, inclusive 2. A clinical diagnosis of moderate to severe COPD according to GOLD guidelines (2010) 3. Current smokers or ex-smokers with at least 10 pack-year smoking history (e.g., at least 1 pack/day for 10 years, or equivalent) 4. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 >30% and 12% and 100 mL during the Screening Period 7. Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005) 8. Willing and able to remain at the study site for at least 24 hours at each study visit 9. Willing and able to provide written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 53
Exclusion criteria
Exclusion criteria: 1. Current evidence or recent history of any clinically significant and unstable disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, lifethreatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities. 2. Primary diagnosis of asthma. 3. History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin. 4. Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to the Screening Period. 5. Use of daily oxygen therapy > 10 hours per day. 6. Use of systemic steroids within 3 months prior to the Screening Period 7. Respiratory tract infection within 6 weeks prior to or during the Screening Period. 8. History of tuberculosis, bronchiectasis or other non-specific pulmonary disease. 9. History of urinary retention or bladder neck obstruction type symptoms. 10. History of narrow-angle glaucoma. 11. Prolonged QTc interval (>460msec) during the Screening Period, or history of long QT syndrome. 12. Recent history (previous 12 months) of excessive use or abuse of alcohol or narcotic/illegal drugs. 13. Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice birth control or abstinence during the study 14. History of hypersensitivity or intolerance to aerosol medications, ß2-agonists, or anticholinergics. 15. Participation in another investigational drug study where drug was received within 30 days prior to the Screening Period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the steady-state efficacy and dose-response profile of EP-101 administered once-daily via eFlow® nebulizer following 7 days of treatment in subjects with moderate to severe COPD.;Secondary Objective: To assess the safety and tolerability of EP-101. To assess the pharmacokinetic (PK) profile of EP-101.;Primary end point(s): The primary efficacy endpoints are change in trough FEV1 and standardized change in FEV1 AUC (0-24, 0-12, and 12-24 hours) at Treatment Visit Day 7.;Timepoint(s) of evaluation of this end point: FEV1 AUC (0-24, 0-12, and 12-24 hours) at Treatment Visit Day 7. Trough FEV1 is defined as the mean of FEV1 values obtained at 23 hours 15 minutes and 23 hours 45 minutes post-dose at each Treatment Visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Actual FEV1 and FVC at individual time points - Change (absolute and percent change) from pre-dose (mean of the two pre-dose values) in FEV1 at individual time points - Peak FEV1 (actual, absolute and percent change, time to peak) - Standardized FEV1 AUC 0-4 hours - Treatment responders;Timepoint(s) of evaluation of this end point: Serial spirometry will be performed during each Treatment Period visit at the following timepoints: 45 minutes and 15 minutes pre-dose; and 5, 15, and 30 minutes and 1, 2, 4, 6, 8, 10, 12, 14, 20, 22 hours, 23hr15min and 23hr45min post-dose. Peak FEV1 is defined as the highest post-dose FEV1 value within 4 hours after study drug administration. A subject will be considered a treatment responder if the change from pre-dose (mean of the two pre-dose values) in trough FEV1 is = 120 mL compared to his/her own change in trough FEV1 from the placebo treatment. Treatment responders will also be calculated with 100 mL taken as the response. | — |
Countries
United Kingdom, United States
Contacts
Public ContactAhmet Tutuncu
Elevation Pharmaceuticals, Inc
Outcome results
None listed