Anti-histamines and Methacholine Challenges.

NCT ID: NCT01985789

Last Updated: 2015-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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diphenhydramine

50mg dose given as two 25mg capsules

Group Type ACTIVE_COMPARATOR

Diphenhydramine

Intervention Type DRUG

cetirizine

10mg dose given as 1 10mg capsule and 1 placebo capsule

Group Type ACTIVE_COMPARATOR

cetirizine

Intervention Type DRUG

desloratadine

5mg dose given as 1 5mg capsule and 1 placebo capsule

Group Type ACTIVE_COMPARATOR

desloratadine

Intervention Type DRUG

placebo

given as 2 placebo capsules

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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Diphenhydramine

Intervention Type DRUG

cetirizine

Intervention Type DRUG

desloratadine

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Don Cockcroft

OTHER

Sponsor Role lead

Responsible Party

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Don Cockcroft

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Donald W Cockcroft, MD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan, Department of Medicine, Division of Respirology, Critical Care and Sleep Medicine

Locations

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University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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PHPY2013/14

Identifier Type: -

Identifier Source: org_study_id

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