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Completed

NCT Number: NCT01690949

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Inflammation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fraunhofer Institut fur Toxicologie und Experimentelle Medicine (ITEM)

Hanover, 30625, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PUR118

Drug

inhaled PUR118, BID

Primary outcomes

  1. Change from baseline in sputum cell counts and inflammatory markers

    Time frame: 6 hours post-initiation of ozone challenge

  2. Change from baseline in white blood cell and inflammatory biomarker counts in blood

    Time frame: 7 and 24 hours post-initiation of ozone challenge

Secondary outcomes

  1. Change from baseline in pulmonary function

    Time frame: all post-dose timepoints up to 24 hours post-initiation of ozone challenge

  2. Changes in clinical signs and symptoms from physical examination at baseline

    Time frame: Subjects will be followed for an expected average of 12 weeks

  3. Changes in clinical safety laboratory tests from baseline

    Time frame: Subjects will be followed for an expected average of 12 weeks

  4. Changes in vital signs from baseline

    Time frame: Subjects will be followed for an expected average of 12 weeks

  5. Changes in ECG from baseline

    Time frame: Subjects will be followed for an expected average of 12 weeks

  6. Number of subjects with adverse events

    Time frame: Subjects will be followed for an expected average of 12 weeks

Sponsors and collaborators

Lead sponsor

Pulmatrix Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 24, 2012
Registry last updated
Jul 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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