NCT01921712

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

5 months

First QC Date

August 9, 2013

Last Update Submit

March 17, 2014

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPDChronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (5)

PUR0200 low dose

EXPERIMENTAL

PUR0200 low dose, single dose inhalation

Drug: PUR0200

PUR0200 mid dose

EXPERIMENTAL

PUR0200 mid dose, single dose inhalation

Drug: PUR0200

PUR0200 high dose

EXPERIMENTAL

PUR0200 high dose, single dose inhalation

Drug: PUR0200

Placebo

PLACEBO COMPARATOR

PUR0200 matched placebo, single dose, inhalation

Drug: PUR0200 Placebo

Active Comparator

ACTIVE COMPARATOR

Active Comparator, single dose, inhalation

Drug: Active comparator

Interventions

PUR0200DRUG

Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator

PUR0200 high dosePUR0200 low dosePUR0200 mid dose
PUR0200 PlaceboDRUG

Randomized, single dose of inhaled placebo matched to PUR0200

Placebo
Active comparatorDRUG

Randomized single dose of inhaled active comparator product

Active Comparator

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Location

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Hava, Ph.D.

    Pulmatrix Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2013

First Posted

August 13, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

GB(2)