Single-Dose, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Bronchodilatory Effects of Glycopyrrolate Inhalation Solution (GIS) Using a High Efficiency Nebulizer in Patients with COPD

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD

• Registration Number: EUCTR2009-010821-38-GB
• Lead Sponsor: Elevation Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

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 < 0.70

6. Improvement in FEV1 >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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified