Anti-histamines and Methacholine Challenges.

Asthma Clinical Trial

Official title:

The Effect of Antihistamines on Methacholine Challenge Testing in Asthma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985789
• Other study ID #: PHPY2013/14
• Status: Completed
• Phase: Phase 4
• First received: October 31, 2013
• Last updated: April 7, 2015
• Start date: November 2013
• Est. completion date: May 2014

Study information

• Verified date: April 2015
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Diphenhydramine

• cetirizine

• desloratadine

• placebo

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
Don Cockcroft

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in methacholine pc20		change from baseline (pre dose) at 2 hours (post dose)	No