Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
inflammation, COPD, respiratory disease, healthy volunteers
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.
Interventions
DRUGPUR118
inhaled PUR118, BID
Sponsors
Pulmatrix Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Change from baseline in pulmonary function | all post-dose timepoints up to 24 hours post-initiation of ozone challenge |
| Number of subjects with adverse events | 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 |
| Changes in clinical signs and symptoms from physical examination at baseline | Subjects will be followed for an expected average of 12 weeks |
Countries
Germany
Outcome results
None listed