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Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers

This study is currently recruiting participants.
Verified September 2012 by Pulmatrix Inc.
Sponsor:
Information provided by (Responsible Party):
Pulmatrix Inc.
ClinicalTrials.gov Identifier:
NCT01690949
First received: September 12, 2012
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

This trial in healthy subjects will assess PUR118's effect on attenuating ozone induced airway inflammation. This trial will establish the tolerability of PUR118 in healthy normal volunteers.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
 Drug: PUR118
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Single-blind Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pulmatrix Inc.:

Primary Outcome Measures:
  • Change from baseline in sputum cell counts and inflammatory markers [ Time Frame: 6 hours post-initiation of ozone challenge ] [ Designated as safety issue: No ]
  • Change from baseline in white blood cell and inflammatory biomarker counts in blood [ Time Frame: 7 and 24 hours post-initiation of ozone challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in pulmonary function [ Time Frame: all post-dose timepoints up to 24 hours post-initiation of ozone challenge ] [ Designated as safety issue: No ]
  • Changes in clinical signs and symptoms from physical examination at baseline [ Time Frame: Subjects will be followed for an expected average of 12 weeks ] [ Designated as safety issue: No ]
  • Changes in clinical safety laboratory tests from baseline [ Time Frame: Subjects will be followed for an expected average of 12 weeks ] [ Designated as safety issue: No ]
  • Changes in vital signs from baseline [ Time Frame: Subjects will be followed for an expected average of 12 weeks ] [ Designated as safety issue: No ]
  • Changes in ECG from baseline [ Time Frame: Subjects will be followed for an expected average of 12 weeks ] [ Designated as safety issue: No ]
  • Number of subjects with adverse events [ Time Frame: Subjects will be followed for an expected average of 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: August 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PUR118 low dose Drug: PUR118
inhaled PUR118, BID
Experimental: PUR118 mid dose Drug: PUR118
inhaled PUR118, BID
Experimental: PUR118 high dose Drug: PUR118
inhaled PUR118, BID

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males or non pregnant, non lactating healthy females age 18-50 years;
  • Must be able to produce acceptable sputum sample by induction;
  • Must respond to ozone inhalation with a > 10% increase in the absolute percentage of sputum neutrophils and the total neutrophils (neutrophils/gram sputum) must increase by at least 50% from the sputum neutrophil count at screening;
  • Volunteer is a non-smoker or ex-smoker of at least 12 months' duration prior to screening with a history of less than 1 pack per year.

Exclusion Criteria:

  • Volunteers receiving chronic medication other than oral contraceptives;
  • Screening forced expiratory volume FEV1 is < 80% of the predicted value for their age, gender, height and race and/or their FEV1/FVC ration is below 70%;
  • Volunteers with significant occupational exposure to respiratory irritants or toxins
  • Upper respiratory tract infection within 30 days of the first study day, or lower respiratory tract infection within the last 3 months;
  • Volunteers taking any medication that may affect the respiratory tract within 30 days of the first study day;
  • Volunteers with a history of asthma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690949

Contacts
Contact: Heike Biller, MD 49-511-53 50-623 heike.biller@item.fraunhofer.de

Locations
Germany
Fraunhofer Institut fur Toxicologie und Experimentelle Medicine (ITEM) Recruiting
Hannover, Germany, 30625
Principal Investigator: Jens Hohlfeld, MD            
Sponsors and Collaborators
Pulmatrix Inc.
Investigators
Study Director: John Hanrahan, MD Pulmatrix Inc.
  More Information

No publications provided

Responsible Party: Pulmatrix Inc.
ClinicalTrials.gov Identifier: NCT01690949     History of Changes
Other Study ID Numbers: 601-0005
Study First Received: September 12, 2012
Last Updated: September 24, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pulmatrix Inc.:
inflammation
COPD
respiratory disease
healthy volunteers

Additional relevant MeSH terms:
Inflammation
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
 Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013