Anti-histamines and Methacholine Challenges.

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Don Cockcroft, University of Saskatchewan

ClinicalTrials.gov Identifier:

NCT01985789

First received: October 31, 2013

Last updated: April 7, 2015

Last verified: April 2015

History of Changes

Purpose

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	Intervention	Phase
Asthma	Drug: Diphenhydramine Drug: cetirizine Drug: desloratadine Drug: placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	The Effect of Antihistamines on Methacholine Challenge Testing in Asthma Patients

Resource links provided by NLM:

MedlinePlus related topics: Cold and Cough Medicines

U.S. FDA Resources

Further study details as provided by Don Cockcroft, University of Saskatchewan:

Primary Outcome Measures:

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


Enrollment:	12
Study Start Date:	November 2013
Study Completion Date:	May 2014
Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01985789

Locations


Canada, Saskatchewan
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

More Information


Responsible Party:	Don Cockcroft, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier:	NCT01985789 History of Changes
Other Study ID Numbers:	PHPY2013/14
Study First Received:	October 31, 2013
Last Updated:	April 7, 2015

Keywords provided by Don Cockcroft, University of Saskatchewan:


airway hyperresponsiveness

Additional relevant MeSH terms:


Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Desloratadine Cetirizine Methacholine Chloride Diphenhydramine Promethazine Cholinergic Antagonists	Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Anti-Allergic Agents Miotics Autonomic Agents Peripheral Nervous System Agents Parasympathomimetics Bronchoconstrictor Agents Respiratory System Agents

ClinicalTrials.gov processed this record on June 28, 2017

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