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

Study Overview
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Brief Summary
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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.

Official Title
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Single-blind Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: PUR118


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PUR118 low dose<br> | Drug: PUR118<br>* inhaled PUR118, BID<br>|
| Experimental: PUR118 mid dose<br> | Drug: PUR118<br>* inhaled PUR118, BID<br>|
| Experimental: PUR118 high dose<br> | Drug: PUR118<br>* inhaled PUR118, BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pulmonary function |  | all post-dose timepoints up to 24 hours post-initiation of ozone challenge | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammation, COPD, respiratory disease, healthy volunteers