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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690949
• Other study ID #: 601-0005
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2012
• Last updated: July 18, 2013
• Start date: August 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: Pulmatrix Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Inflammation
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• PUR118
inhaled PUR118, BID

Locations

Country	Name	City	State
Germany	Fraunhofer Institut fur Toxicologie und Experimentelle Medicine (ITEM)	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Pulmatrix Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in sputum cell counts and inflammatory markers		6 hours post-initiation of ozone challenge	No
Primary	Change from baseline in white blood cell and inflammatory biomarker counts in blood		7 and 24 hours post-initiation of ozone challenge	No
Secondary	Change from baseline in pulmonary function		all post-dose timepoints up to 24 hours post-initiation of ozone challenge	No
Secondary	Changes in clinical signs and symptoms from physical examination at baseline		Subjects will be followed for an expected average of 12 weeks	No
Secondary	Changes in clinical safety laboratory tests from baseline		Subjects will be followed for an expected average of 12 weeks	No
Secondary	Changes in vital signs from baseline		Subjects will be followed for an expected average of 12 weeks	No
Secondary	Changes in ECG from baseline		Subjects will be followed for an expected average of 12 weeks	No
Secondary	Number of subjects with adverse events		Subjects will be followed for an expected average of 12 weeks	No