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

P

Pulmatrix

Status and phase

Completed
Phase 1

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: PUR118

Study type

Interventional

Funder types

Industry

Identifiers

NCT01690949
601-0005

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

24 participants in 3 patient groups

PUR118 low dose
Experimental group
Treatment:
Drug: PUR118
PUR118 mid dose
Experimental group
Treatment:
Drug: PUR118
PUR118 high dose
Experimental group
Treatment:
Drug: PUR118

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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