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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pulmatrix Inc.

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