Airway Response to Repeat Allergen Challenge and the Effect of Ibuprofen in Mild Atopic Asthma
Assessment of Repeated Allergen Challenge and the Effects of Ibuprofen on the Inflammatory Process
1 other identifier
interventional
13
1 country
1
Brief Summary
The study will assess airway responses in mild atopic asthmatics undergoing repeat allergen challenge testing and will investigate whether ibuprofen changes the response.
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 Dec 2014
Shorter than P25 for not_applicable
1 active site
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
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 17, 2014
CompletedFirst Posted
Study publicly available on registry
December 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedApril 20, 2016
April 1, 2016
4 months
December 17, 2014
April 19, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Airway response to inhaled allergen
area under forced expiratory volume in one second versus time curve; 0-3hours (early response) and 3-7 hours (late response)
at time of allergen inhalation challenge and for 7 hours after
Secondary Outcomes (1)
Airway response to inhaled methacholine
day before allergen inhalation challenge and 8 hours after allergen inhalation challenge
Study Arms (2)
Ibuprofen
EXPERIMENTAL400mg (2X200mg) ibuprofen single dose once
Placebo
PLACEBO COMPARATORidentical appearing lactose capsules single dose 2 capsules once
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of mild asthma, currently well controlled requiring only a bronchodilator (e.g. salbutamol) as needed and infrequently
- has allergies that trigger asthma
- responds to methacholine challenge at 16mg/ml or less
- has FEV1 \> 69.5% predicted
You may not qualify if:
- respiratory illness within 4 weeks
- other medical condition assessed by the principal investigator that would put the participant at risk or influence the integrity of the data
- pregnant or lactating females
- hypersensitivity to ibuprofen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Saskatchewan
Saskatoon, Saskatchewan, S7N0W8, Canada
Related Publications (1)
Nomani S, Cockcroft DW, Davis BE. Allergen inhalation challenge, refractoriness and the effects of ibuprofen. Allergy Asthma Clin Immunol. 2016 May 24;12:24. doi: 10.1186/s13223-016-0127-z. eCollection 2016.
PMID: 27222654DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Don Cockcroft, MD
University of Saskatchewan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 17, 2014
First Posted
December 30, 2014
Study Start
December 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
April 20, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will share
journal publication