A Safety, Pharmacokinetic and Pharmacodynamic Study of PUR0200 in COPD Patients

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: PUR0200; Drug: PUR0200 Placebo; Drug: Active comparator

• Registration Number: NCT01921712
• Lead Sponsor: Pulmatrix Inc.

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 COPD patients.

Detailed Description

This is a multi-center, 2-part, pharmacokinetic (PK), pharmacodynamic (PD) effect, safety and tolerability study of single doses of PUR0200.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-09
• Study First Submitted QC: 2013-08-09
• Study First Posted: 2013-08-13
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-17
• Last Update Posted: 2014-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PUR0200 low dose	PUR0200	PUR0200 low dose, single dose inhalation
Placebo	PUR0200 Placebo	PUR0200 matched placebo, single dose, inhalation
Active Comparator	Active comparator	Active Comparator, single dose, inhalation
PUR0200 mid dose	PUR0200	PUR0200 mid dose, single dose inhalation
PUR0200 high dose	PUR0200	PUR0200 high dose, single dose inhalation

Primary Outcome Measures

Name	Time	Method
Peak plasma concentration (Cmax) of PUR0200	0 to 24 hours
Time to reach peak plasma (Tmax) concentration of PUR0200	0 to 24 hours
Area under the plasma concentration versus time (AUC) of PUR0200	0 to 24 hours
Trough forced expiratory volume in 1 second (FEV1)	24 hours
Trough FEV1 difference from baseline	24 hours
Number of participants with adverse events	up to 14 days post-dose	adverse events, vital signs, clinical laboratory changes, and ECG changes will be evaluated

Trial Locations

Locations (2)

Medicines Evaluation Unit; 🇬🇧 Manchester, United Kingdom

Quotient Clinical; 🇬🇧 Nottingham, United Kingdom