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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: PUR0200; Drug: PUR0200 Placebo; Drug: Active comparator

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M23 9QZ
    • Medicines Evaluation Unit
  • Nottingham, United Kingdom, NG11 6JS
    • Quotient Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PUR0200 low dose; PUR0200 low dose, single dose inhalation	Drug: PUR0200; Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator
Experimental: PUR0200 mid dose; PUR0200 mid dose, single dose inhalation	Drug: PUR0200; Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator
Experimental: PUR0200 high dose; PUR0200 high dose, single dose inhalation	Drug: PUR0200; Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator
Placebo Comparator: Placebo; PUR0200 matched placebo, single dose, inhalation	Drug: PUR0200 Placebo; Randomized, single dose of inhaled placebo matched to PUR0200
Active Comparator: Active Comparator; Active Comparator, single dose, inhalation	Drug: Active comparator; Randomized single dose of inhaled active comparator product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	adverse events, vital signs, clinical laboratory changes, and ECG changes will be evaluated	up to 14 days post-dose

Collaborators and Investigators

• Sponsor: Pulmatrix Inc.
• Collaborators: Quotient Clinical
• Investigators: Study Director: David Hava, Ph.D., Pulmatrix Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 9, 2013
• First Submitted That Met QC Criteria: August 9, 2013
• First Posted (Estimate): August 13, 2013

Study Record Updates

• Last Update Posted (Estimate): March 18, 2014
• Last Update Submitted That Met QC Criteria: March 17, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: COPD; Chronic Obstructive Pulmonary Disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 601-0010P