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

NCT01690949 | Completed Phase 1

• 1 other identifier: 601-0005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

inflammation; COPD; respiratory disease; healthy volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (3)

PUR118 low dose

EXPERIMENTAL

Drug: PUR118

PUR118 mid dose

EXPERIMENTAL

Drug: PUR118

PUR118 high dose

EXPERIMENTAL

Drug: PUR118

Interventions

PUR118 DRUG

inhaled PUR118, BID

PUR118 high dose; PUR118 low dose; PUR118 mid dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pulmatrix Inc.: lead

Study Sites (1)

Fraunhofer Institut fur Toxicologie und Experimentelle Medicine (ITEM)

Hanover, 30625, Germany

Location

Related Publications (1)

• 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.

  PMID: 26265479 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Inflammation; Respiration Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John Hanrahan, MD

  Pulmatrix Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 24, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 19, 2013

Record last verified: 2013-07

Locations

DE (1)