Completed
Single-blind Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers
What is being tested
PUR118
+ PUR118
+ PUR118
Drug
Who is being recruted
Chronic Disease+7
+ Lung Diseases
+ Lung Diseases, Obstructive
From 18 to 50 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: August 2012
Summary
Principal SponsorPulmatrix Inc.
Last updated: July 19, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorPulmatrix Inc.
Last updated: July 19, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesInflammationRespiration DisordersPulmonary Disease, Chronic Obstructive
Criteria
4 inclusion criteria required to participate
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
6 exclusion criteria prevent from participating
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%
Upper respiratory tract infection within 30 days of the first study day, or lower respiratory tract infection within the last 3 months
Volunteers receiving chronic medication other than oral contraceptives
Volunteers taking any medication that may affect the respiratory tract within 30 days of the first study day
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Fraunhofer Institut fur Toxicologie und Experimentelle Medicine (ITEM)
Hanover, GermanyOpen Fraunhofer Institut fur Toxicologie und Experimentelle Medicine (ITEM) in Google MapsCompletedOne Study Center