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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
PUR0200
PUR0200 Placebo
Active comparator
Sponsored by
Pulmatrix Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medicines Evaluation Unit
  • Quotient Clinical

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

PUR0200 low dose

PUR0200 mid dose

PUR0200 high dose

Placebo

Active Comparator

Arm Description

PUR0200 low dose, single dose inhalation

PUR0200 mid dose, single dose inhalation

PUR0200 high dose, single dose inhalation

PUR0200 matched placebo, single dose, inhalation

Active Comparator, single dose, inhalation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 9, 2013
Last Updated
March 17, 2014
Sponsor
Pulmatrix Inc.
Collaborators
Quotient Clinical
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1. Study Identification

Unique Protocol Identification Number
NCT01921712
Brief Title
A Safety, Pharmacokinetic and Pharmacodynamic Study of PUR0200 in COPD Patients
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulmatrix Inc.
Collaborators
Quotient Clinical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PUR0200 low dose
Arm Type
Experimental
Arm Description
PUR0200 low dose, single dose inhalation
Arm Title
PUR0200 mid dose
Arm Type
Experimental
Arm Description
PUR0200 mid dose, single dose inhalation
Arm Title
PUR0200 high dose
Arm Type
Experimental
Arm Description
PUR0200 high dose, single dose inhalation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
PUR0200 matched placebo, single dose, inhalation
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Active Comparator, single dose, inhalation
Intervention Type
Drug
Intervention Name(s)
PUR0200
Intervention Description
Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator
Intervention Type
Drug
Intervention Name(s)
PUR0200 Placebo
Intervention Description
Randomized, single dose of inhaled placebo matched to PUR0200
Intervention Type
Drug
Intervention Name(s)
Active comparator
Intervention Description
Randomized single dose of inhaled active comparator product
Primary Outcome Measure Information:
Title
Peak plasma concentration (Cmax) of PUR0200
Time Frame
0 to 24 hours
Title
Time to reach peak plasma (Tmax) concentration of PUR0200
Time Frame
0 to 24 hours
Title
Area under the plasma concentration versus time (AUC) of PUR0200
Time Frame
0 to 24 hours
Title
Trough forced expiratory volume in 1 second (FEV1)
Time Frame
24 hours
Title
Trough FEV1 difference from baseline
Time Frame
24 hours
Title
Number of participants with adverse events
Description
adverse events, vital signs, clinical laboratory changes, and ECG changes will be evaluated
Time Frame
up to 14 days post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hava, Ph.D.
Organizational Affiliation
Pulmatrix Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Medicines Evaluation Unit
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
Facility Name
Quotient Clinical
City
Nottingham
ZIP/Postal Code
NG11 6JS
Country
United Kingdom

12. IPD Sharing Statement

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

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