Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Name: GIS(GLYCOPYRROLATE INHALATION SOLUTION)
Product Code: EP-101
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Glycopyrrolate
CAS Number: 596-51-0
Current Sponsor code: EP-10
Sponsors
Elevation Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients will be eligible for the study if they meet all of the following inclusion criteria: 1. Male and female patients age 40 through 65 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 40-80% of predicted normal 5. Post-bronchodilator FEV1/FVC ratio 12% (and 150 mL) following inhalation of ipratropium bromide 7. Ability to perform reproducible spirometry according to the ATS/ERS guidelines 8. If female and of childbearing potential, must have a negative pregnancy test and not lactating at the Screening Visit, and must be using one of the following acceptable means of birth control throughout the study: - Post-menopausal for at least two years - Surgically sterile - Oral contraceptives (taken for at least one month prior to the Screening Visit) - Approved implantable or injectable contraceptives (e.g., Norplant®, Depo- Provera® or equivalent) - Barrier methods (e.g., condoms with spermicide) - Intrauterine device (i.e., IUD) - Vasectomy of male partner - Non-heterosexual life style 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will be eligible for the study if they do not meet any of the following exclusion criteria: 1. 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 subjects at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, hypertension, arrhythmia, diabetes, neurological or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities 2. Recent history of an exacerbation of airway disease within 3 months or need for increased treatments for COPD within 6 weeks prior to the Screening Visit 3. Regular use of daily oxygen therapy 4. Use of systemic steroids within 3 months prior to the Screening Visit 5. Respiratory tract infection within 6 weeks prior to the Screening Visit 6. History of tuberculosis, bronchiectasis or other non-specific pulmonary disease 7. History of urinary retention or bladder neck obstruction type symptoms 8. History of narrow-angle glaucoma 9. Current or recent history (previous 12 months) of excessive use or abuse of alcohol 10. Current evidence or history of abusing legal drugs or use of illegal drugs or substances 11. History of hypersensitivity or intolerance to aerosol medications 12. Participation in another investigational drug study within 30 days prior to the Screening Visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The Primary Objective of the trial is: - To assess the safety and tolerability of single ascending doses of GIS when administered using a high efficiency nebulizer in patients with COPD.;Secondary Objective: The Secondary Objectives of the trial are: - To assess and to compare the magnitude and duration of bronchodilator response in patients with COPD following single doses of GIS when administered using a high efficiency nebulizer and a general purpose nebulizer. - To assess the pharmacokinetic (PK) profile of glycopyrrolate. ;Primary end point(s): The primary efficacy variables of this study will include the following: • Trough FEV1 response (mean change from baseline at 24 hours post-dosing) • Change (absolute and percent change) in FEV1 at individual time points • Maximum FEV1 response (actual and percent change) • Onset of bronchodilator action (>15% increase in FEV1 from baseline) • Duration of bronchodilator response • Area under the absolute FEV1 curve from baseline to 3 hours post-dosing (FEV1 AUC 0-3) • FEV1 and FVC at individual time points • PEFR at individual time points | — |
Countries
United Kingdom
Outcome results
None listed