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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: PUR118

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Fraunhofer Institut fur Toxicologie und Experimentelle Medicine (ITEM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PUR118 low dose	Drug: PUR118; inhaled PUR118, BID
Experimental: PUR118 mid dose	Drug: PUR118; inhaled PUR118, BID
Experimental: PUR118 high dose	Drug: PUR118; inhaled PUR118, BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pulmatrix Inc.
• Investigators: Study Director: John Hanrahan, MD, Pulmatrix Inc.

Publications and helpful links

General Publications

• Holz O, Biller H, Mueller M, Kane K, Rosano M, Hanrahan J, Hava DL, Hohlfeld JM. Efficacy and safety of inhaled calcium lactate PUR118 in the ozone challenge model--a clinical trial. BMC Pharmacol Toxicol. 2015 Aug 12;16:21. doi: 10.1186/s40360-015-0021-1.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (Estimate): September 24, 2012

Study Record Updates

• Last Update Posted (Estimate): July 19, 2013
• Last Update Submitted That Met QC Criteria: July 18, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: COPD; inflammation; healthy volunteers; respiratory disease
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Inflammation
• Other Study ID Numbers: 601-0005