Status:
COMPLETED
A Safety, Pharmacokinetic and Pharmacodynamic Study of PUR0200 in COPD Patients
Lead Sponsor:
Pulmatrix Inc.
Collaborating Sponsors:
Quotient Clinical
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
Brief Summary
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 C...
Detailed Description
This is a multi-center, 2-part, pharmacokinetic (PK), pharmacodynamic (PD) effect, safety and tolerability study of single doses of PUR0200.
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01921712
Start Date
July 1 2013
End Date
December 1 2013
Last Update
March 18 2014
Active Locations (2)
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1
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ
2
Quotient Clinical
Nottingham, United Kingdom, NG11 6JS