Discovering New Treatments for Asthma and COPD. A New Human Rhinvovirus for Human Challenge
1 other identifier
interventional
17
0 countries
N/A
Brief Summary
A GMP rhinovirus was manufactured according to GMP and then characterised in human volunteers in the human viral challenge model.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2013
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 28, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedAugust 13, 2015
August 1, 2015
1.5 years
July 28, 2015
August 12, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Virus shedding defined as area under the curve
10 days
Secondary Outcomes (1)
Symptoms of respiratory tract infection
10 days
Study Arms (3)
Titre 1
EXPERIMENTALLow infectious titre of innoculum
Titre 2
EXPERIMENTALMedium infectious titre of innoculum
Titre 3
EXPERIMENTALHigh infectious titre of innoculum
Interventions
Eligibility Criteria
You may qualify if:
- Young healthy adults as determined by medical history, physical examination, serology (HIV and Hepatitis B and C) and clinical laboratory tests.
- Female subjects were required to provide of a history of reliable contraceptive practice.
You may not qualify if:
- asthma,
- hypersensitivity to mercurials or chicken eggs,
- anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration, chronic nasopharyngeal complaints,
- abnormal electrocardiogram (ECG),
- febrile illness or significant symptoms of upper respiratory infection on the day of
- Subjects using medication or other products for rhinitis or nasal congestion,
- Subject who had received systemic glucocorticoids within 1 month, or cytotoxic or immunosuppressive drugs within 6 months of the study start.
- Subjects agreed not to smoke during the quarantine phase.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hvivolead
Related Publications (1)
Fullen DJ, Murray B, Mori J, Catchpole A, Borley DW, Murray EJ, Balaratnam G, Gilbert A, Mann A, Hughes F, Lambkin-Williams R. A Tool for Investigating Asthma and COPD Exacerbations: A Newly Manufactured and Well Characterised GMP Wild-Type Human Rhinovirus for Use in the Human Viral Challenge Model. PLoS One. 2016 Dec 9;11(12):e0166113. doi: 10.1371/journal.pone.0166113. eCollection 2016.
PMID: 27936016DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Bryan Murray, MD
PI
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2015
First Posted
August 13, 2015
Study Start
January 1, 2013
Primary Completion
July 1, 2014
Study Completion
December 1, 2014
Last Updated
August 13, 2015
Record last verified: 2015-08