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
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: PUR003
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pulmatrix Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: July 2009
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PUR003 Drug: PUR003
Twice-daily (BID) doses of PUR003 will be delivered via inhalation using a commercially available nebulizer for a total of 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947687

Locations
United Kingdom
Guys Drug Research Unit (GDRU), Quintiles Ltd
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
Pulmatrix Inc.
Retroscreen Virology Ltd.
Guys Drug Research Unit
Quintiles UK
Investigators
Study Director: John P Hanrahan, MD Pulmatrix Inc.
  More Information

No publications provided

Responsible Party: John Hanrahan, MD, MPH; Chief Medical Officer, Pulmatrix Inc.
ClinicalTrials.gov Identifier: NCT00947687     History of Changes
Other Study ID Numbers: 601-0001P-00
Study First Received: July 24, 2009
Last Updated: April 27, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Pulmatrix Inc.:
influenza
healthy subject
virus inoculation
symptom scores
viral shedding
bioaerosol output

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014