Clinical trial NCT01690949: Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers
Official title: Single-blind Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: inflammation
COPD
respiratory disease
healthy volunteers
Lead sponsor: Pulmatrix Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in sputum cell counts and inflammatory markers
timeFrame: 6 hours post-initiation of ozone challenge
measure: Change from baseline in white blood cell and inflammatory biomarker counts in blood
timeFrame: 7 and 24 hours post-initiation of ozone challenge
Secondary outcomes:
measure: Change from baseline in pulmonary function
timeFrame: all post-dose timepoints up to 24 hours post-initiation of ozone challenge
measure: Changes in clinical signs and symptoms from physical examination at baseline
timeFrame: Subjects will be followed for an expected average of 12 weeks
measure: Changes in clinical safety laboratory tests from baseline
timeFrame: Subjects will be followed for an expected average of 12 weeks
measure: Changes in vital signs from baseline
timeFrame: Subjects will be followed for an expected average of 12 weeks
measure: Changes in ECG from baseline
timeFrame: Subjects will be followed for an expected average of 12 weeks
measure: Number of subjects with adverse events
timeFrame: Subjects will be followed for an expected average of 12 weeks
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Fraunhofer Institut fur Toxicologie und Experimentelle Medicine (ITEM)
Study officials:
affiliation: Pulmatrix Inc.
name: John Hanrahan, MD
role: STUDY_DIRECTOR
References:
citation: 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.