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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-04-30

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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PUR118 low dose

Group Type EXPERIMENTAL

PUR118

Intervention Type DRUG

inhaled PUR118, BID

PUR118 mid dose

Group Type EXPERIMENTAL

PUR118

Intervention Type DRUG

inhaled PUR118, BID

PUR118 high dose

Group Type EXPERIMENTAL

PUR118

Intervention Type DRUG

inhaled PUR118, BID

Interventions

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PUR118

inhaled PUR118, BID

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes