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

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: PUR118

• Registration Number: NCT01690949
• Lead Sponsor: Pulmatrix Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-19
• Study First Posted: 2012-09-24
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-18
• Last Update Posted: 2013-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PUR118 mid dose	PUR118	-
PUR118 high dose	PUR118	-
PUR118 low dose	PUR118	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in sputum cell counts and inflammatory markers	6 hours post-initiation of ozone challenge
Change from baseline in white blood cell and inflammatory biomarker counts in blood	7 and 24 hours post-initiation of ozone challenge

Secondary Outcome Measures

Name	Time	Method
Changes in clinical signs and symptoms from physical examination at baseline	Subjects will be followed for an expected average of 12 weeks
Changes in clinical safety laboratory tests from baseline	Subjects will be followed for an expected average of 12 weeks
Changes in vital signs from baseline	Subjects will be followed for an expected average of 12 weeks
Changes in ECG from baseline	Subjects will be followed for an expected average of 12 weeks
Number of subjects with adverse events	Subjects will be followed for an expected average of 12 weeks
Change from baseline in pulmonary function	all post-dose timepoints up to 24 hours post-initiation of ozone challenge

Trial Locations

Locations (1)

Fraunhofer Institut fur Toxicologie und Experimentelle Medicine (ITEM); 🇩🇪 Hannover, Germany