Randomized, Placebo-Controlled, Double-Blind, Dose Ranging, Single Dose, 6-Way Crossover Study to Assess the Safety, Efficacy and Pharmacokinetics of EP-101 Using eFlow Nebulizer in Patients with COPD
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 12.1Level: LLTClassification code 10010952Term: COPD
- Registration Number
- EUCTR2010-018987-17-GB
- Lead Sponsor
- Elevation Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Male or female age 40 through 75 years, inclusive
2. A clinical diagnosis of COPD according to the GOLD guidelines
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 10 packs/day for 1 year)
4. Post-bronchodilator FEV1 30-70% of predicted normal at the Screening Visit
5. Post-bronchodilator FEV1/FVC ratio < 0.70 at the Screening Visit
6. Improvement in FEV1 >12% and 150 mL following inhalation of ipratropium bromide at the Screening Visit
7. Ability to perform reproducible spirometry according to the ATS/ERS guidelines
8. Willing to stay at the study site for at least 30 hours on each treatment 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Females who are pregnant or lactating at the Screening Visit, or if of childbearing potential not using one of the following acceptable means of birth control throughout the study:
a. Abstinence
b. Post-menopausal for at least two years
c. Surgically sterile (i.e., tubal ligation, hysterectomy)
d. Oral contraceptives (taken for at least one month prior to the Screening Visit)
e. Approved implantable or injectable contraceptives (e.g., Norplant®, Depo-Provera® or equivalent)
f. Barrier methods (e.g., condoms with spermicide)
g. Intrauterine device (i.e., IUD)
h. Vasectomy of male partner
i. Non-heterosexual life style
2. Current evidence or recent history of any clinically significant 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, life-threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities
3. Recent history of hospitalization due to an exacerbation of airway disease within 3 months or need for increased treatments for COPD within 6 weeks prior to the Screening Visit
4. Primary diagnosis of asthma
5. Prior lung volume reduction surgery or history of chest/lung irradiation
6. Regular use of daily oxygen therapy
7. Use of systemic steroids within 3 months prior to the Screening Visit
8. Respiratory tract infection within 6 weeks prior to the Screening Visit
9. History of tuberculosis, bronchiectasis or other non-specific pulmonary disease
10. History of urinary retention or bladder neck obstruction type symptoms
11. History of narrow-angle glaucoma
12. Clinically significant abnormal ECG
13. Positive Hepatitis B surface antigen or positive Hepatitis C antibody
14. Positive screening test for HIV antibodies
15. Current or recent history (previous 12 months) of excessive use or abuse of alcohol
16. Current evidence or history of abusing legal drugs or use of illegal drugs or substances
17. Donation of 450 mL of blood within 8 weeks of the Screening Visit
18. History of hypersensitivity or intolerance to aerosol medications
19. Participation in another investigational drug study where drug was received within 30 days prior to the Screening Visit
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish the dose response characteristics of EP-101 as demonstrated by changes in FEV1 (including trough FEV1 at 24 hours and FEV1 AUC).;Secondary Objective: To assess the pharmacokinetic profile of glycopyrrolate. <br>To assess the safety and tolerability of EP-101.<br> ;Primary end point(s): •Trough FEV1 at 24 hours (mean change from pre-dose at 24 hours post-dosing)<br>•Area under the absolute FEV1 curve from pre-dose to 24 hours post-dosing (FEV1 AUC 0-24)<br>•Area under the absolute FEV1 curve from pre-dose to 12 hours post-dosing (FEV1 AUC 0-12)<br>•Area under the absolute FEV1 curve from 12 hours to 24 hours post-dosing (FEV1 AUC 12-24)<br>•Maximum FEV1 response through 24 hours (absolute and percent change)<br>•Onset of bronchodilator response (>12% change from pre-dose in FEV1) <br>•Duration of bronchodilator response <br>•Change from pre-dose in FEV1 at individual time points (absolute and percent change)<br>•Actual FEV1 and FVC at individual time points<br>
- Secondary Outcome Measures
Name Time Method