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OpenTrials
Completed

NCT Number: NCT01985789

Anti-histamines and Methacholine Challenges.

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diphenhydramine

Drug

Cetirizine

Drug

desloratadine

Drug

Placebo

Drug

Primary outcomes

  1. change in methacholine pc20

    Time frame: change from baseline (pre dose) at 2 hours (post dose)

Sponsors and collaborators

Lead sponsor

Don Cockcroft

Other

Registry information

Official study title

The Effect of Antihistamines on Methacholine Challenge Testing in Asthma Patients

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 15, 2013
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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