Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
A Phase I, 2-Part, Single-dose, Placebo and Active-Controlled, Dose-ranging, Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to assess the safety and tolerability of PUR0200. In addition, the study will look at the blood levels of different doses of PUR0200 and their affect on lung function in COPD patients.
Status | Completed |
Enrollment | 38 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
Key Inclusion Criteria: - A clinical diagnosis of moderate to severe COPD according to the following criteria: - Current or ex-smokers with at least 10 pack-year smoking history - Post-bronchodilator FEV1 >/= 35% and </= 80% of predicted normal value - Post-bronchodilator FEV1/FVC (forced vital capacity) ratio <0.70 - Post-bronchodilator improvement in FEV1 >/= 100 mL Key Exclusion Criteria: - Current evidence or recent history of clinically significant or unstable disease (other than COPD) - Current diagnosis of asthma - Presence of history of clinically significant allergy requiring treatment - COPD exacerbation within 6 weeks - Use of daily oxygen therapy > 10 hours - Thoracotomy with pulmonary resection - Use of systemic steroids within 3 months - Lower respiratory tract infection within 30 days - Upper respiratory tract infection within 30 days requiring treatment with antibiotics - History of tuberculosis, bronchiectasis, or other non-specific pulmonary disease - Prolonged corrected QT (QTc) interval >450 msec males and >470 msec females, or history of long QT syndrome |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Medicines Evaluation Unit | Manchester | |
United Kingdom | Quotient Clinical | Nottingham |
Lead Sponsor | Collaborator |
---|---|
Pulmatrix Inc. | Quotient Clinical |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak plasma concentration (Cmax) of PUR0200 | 0 to 24 hours | No | |
Primary | Time to reach peak plasma (Tmax) concentration of PUR0200 | 0 to 24 hours | No | |
Primary | Area under the plasma concentration versus time (AUC) of PUR0200 | 0 to 24 hours | No | |
Primary | Trough forced expiratory volume in 1 second (FEV1) | 24 hours | No | |
Primary | Trough FEV1 difference from baseline | 24 hours | No | |
Primary | Number of participants with adverse events | adverse events, vital signs, clinical laboratory changes, and ECG changes will be evaluated | up to 14 days post-dose | No |
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