Anti-histamines and Methacholine Challenges.

Sponsor

Don Cockcroft (Other)

Overall Status

Completed

CT.gov ID

NCT01985789

Collaborator

(none)

Enrollment

Location

Arms

5.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Diphenhydramine Drug: cetirizine Drug: desloratadine Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

The Effect of Antihistamines on Methacholine Challenge Testing in Asthma Patients

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: diphenhydramine 50mg dose given as two 25mg capsules	Drug: Diphenhydramine
Active Comparator: cetirizine 10mg dose given as 1 10mg capsule and 1 placebo capsule	Drug: cetirizine
Active Comparator: desloratadine 5mg dose given as 1 5mg capsule and 1 placebo capsule	Drug: desloratadine
Placebo Comparator: placebo given as 2 placebo capsules	Drug: placebo

Outcome Measures

Primary Outcome Measures

change in methacholine pc20 [change from baseline (pre dose) at 2 hours (post dose)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

pregnant or breastfeeding females
unable to withhold antihistamines, anticholinergics, long acting bronchodilators and combination therapies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Saskatchewan	Saskatoon	Saskatchewan	Canada	S7N 0W8

Sponsors and Collaborators

Don Cockcroft

Investigators

Principal Investigator: Donald W Cockcroft, MD, University of Saskatchewan, Department of Medicine, Division of Respirology, Critical Care and Sleep Medicine