Anti-histamines and Methacholine Challenges.
The Effect of Antihistamines on Methacholine Challenge Testing in Asthma Patients
1 other identifier
interventional
12
1 country
1
Brief Summary
The asthmatic airway is identified and studied using inhaled agents such as histamine and methacholine. The use of antihistamines prior to the test will inhibit the test result if histamine is used to cause airway constriction. If using methacholine, this may also be true depending on whether old (e.g. benadryl) or new (e.g. desloratadine) antihistamines are used. This study will look at the effect of old and new antihistamines on inhaled methacholine challenge response in individuals with mild asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 asthma
Started Nov 2013
Shorter than P25 for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedApril 8, 2015
April 1, 2015
6 months
October 31, 2013
April 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in methacholine pc20
change from baseline (pre dose) at 2 hours (post dose)
Study Arms (4)
diphenhydramine
ACTIVE COMPARATOR50mg dose given as two 25mg capsules
cetirizine
ACTIVE COMPARATOR10mg dose given as 1 10mg capsule and 1 placebo capsule
desloratadine
ACTIVE COMPARATOR5mg dose given as 1 5mg capsule and 1 placebo capsule
placebo
PLACEBO COMPARATORgiven as 2 placebo capsules
Interventions
Eligibility Criteria
You may qualify if:
- Baseline forced expiratory volume in 1s (FEV1) of 70% or more of predicted
- Methacholine provocative concentration causing a 20% fall in FEV1 16mg/ml or less
- No respiratory infection or change in allergen exposure for 4 weeks prior to screening and throughout the study
- No significant medical co-morbidities
- allergy
You may not qualify if:
- pregnant or breastfeeding females
- unable to withhold antihistamines, anticholinergics, long acting bronchodilators and combination therapies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Don Cockcroftlead
Study Sites (1)
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald W Cockcroft, MD
University of Saskatchewan, Department of Medicine, Division of Respirology, Critical Care and Sleep Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 31, 2013
First Posted
November 15, 2013
Study Start
November 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
April 8, 2015
Record last verified: 2015-04