Safety and Efficacy Study of Inhaled PUR003 on a Controlled Influenza Virus Challenge in Healthy Adult Subjects

This study has been completed.
Sponsor:
Collaborators:
Retroscreen Virology Ltd.
Guys Drug Research Unit
Quintiles UK
Information provided by:
Pulmatrix Inc.
ClinicalTrials.gov Identifier:
NCT00947687
First received: July 24, 2009
Last updated: April 27, 2010
Last verified: April 2010

July 24, 2009
April 27, 2010
July 2009
September 2009   (final data collection date for primary outcome measure)
Safety and tolerability of PUR003 as determined by incidence of adverse events (AEs); changes in physical examination, chest examination; pulmonary function; vital signs; electrocardiogram (ECG) and clinical laboratory assessments. [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00947687 on ClinicalTrials.gov Archive Site
  • Subjected-reported symptom scores assessed both individually and as a composite score evaluating severity overall and at the time of peak symptom score [ Time Frame: Day 6 of study ] [ Designated as safety issue: No ]
  • Quantitative viral shedding from nasal viral inoculation until day 6 [ Time Frame: Day 0 to day 6 ] [ Designated as safety issue: No ]
  • Change in bioaerosol output with treatment and after viral inoculation [ Time Frame: Day -2 to day 6 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Inhaled PUR003 on a Controlled Influenza Virus Challenge in Healthy Adult Subjects
A Randomized, Phase 1B, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Inhaled PUR003 on a Controlled Influenza Virus Challenge in Healthy Adult Subjects

The objectives of the study are to demonstrate the effectiveness, safety and tolerability of multiple daily doses of inhaled PUR003, in comparison with placebo, in healthy adults experimentally inoculated with Influenza A/Wisconsin/67/2005 (H3N2) virus.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
Drug: PUR003
Twice-daily (BID) doses of PUR003 will be delivered via inhalation using a commercially available nebulizer for a total of 7 days
Experimental: PUR003
Intervention: Drug: PUR003
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
October 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female subjects aged 18 to 45 years.
  • In general good health determined by a screening evaluation ≤120 days prior to double-blind IMP administration and on the day of admittance to quarantine.
  • Seronegative (NDA) for challenge virus.
  • Have not been vaccinated for influenza virus since 2006 (as determined in the medical history) or had a known influenza infection in the current season, defined as in the last 12 months.

Exclusion Criteria:

  • Presence or evidence of significant acute or chronic, uncontrolled medical or psychiatric illness.
  • Abnormal pulmonary function as evidenced by clinically significant abnormality in spirometry.
  • Health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of discharge from quarantine.
  • Intending to travel (to countries for which vaccinations are recommended or where high risk of infections exists).
  • Presence of household member or close contact (until 14 days after discharge from quarantine) who is: less than 3 years of age; has any known immunodeficiency; is receiving immunosuppressant medications; is undergoing or soon to undergo cancer chemotherapy within 28 days of challenge.
  • Subjects with diagnosed emphysema or chronic obstructive pulmonary disease (COPD); elderly residing in a nursing home, affected by severe lung disease or medical condition; or a transplant (bone marrow or solid organ) organ recipient
  • Subjects with any history of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any aetiology.
  • Regular daily smokers during the 6 months prior to study entry or those who have a significant history of any tobacco use at any time (≥ total 10 pack year history = one pack a day for 10 years).
  • Presence of any febrile illness or symptoms of upper or lower tract respiratory infection in the 28 days prior to viral inoculation (such subjects may be re-evaluated for enrolment after resolution of the illness).
  • Receipt of any investigational drug within 3 months, or prior participation in a clinical trial of any influenza vaccine or medication within 1 year of participation.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00947687
601-0001P-00
No
John Hanrahan, MD, MPH; Chief Medical Officer, Pulmatrix Inc.
Pulmatrix Inc.
  • Retroscreen Virology Ltd.
  • Guys Drug Research Unit
  • Quintiles UK
Study Director: John P Hanrahan, MD Pulmatrix Inc.
Pulmatrix Inc.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP