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Anti-histamines and Methacholine Challenges.

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Diphenhydramine
cetirizine
desloratadine
placebo
Sponsored by
Don Cockcroft
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma focused on measuring airway hyperresponsiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

diphenhydramine

cetirizine

desloratadine

placebo

Arm Description

50mg dose given as two 25mg capsules

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

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

given as 2 placebo capsules

Outcomes

Primary Outcome Measures

change in methacholine pc20

Secondary Outcome Measures

Full Information

First Posted
October 31, 2013
Last Updated
April 7, 2015
Sponsor
Don Cockcroft
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1. Study Identification

Unique Protocol Identification Number
NCT01985789
Brief Title
Anti-histamines and Methacholine Challenges.
Official Title
The Effect of Antihistamines on Methacholine Challenge Testing in Asthma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Don Cockcroft

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
airway hyperresponsiveness

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diphenhydramine
Arm Type
Active Comparator
Arm Description
50mg dose given as two 25mg capsules
Arm Title
cetirizine
Arm Type
Active Comparator
Arm Description
10mg dose given as 1 10mg capsule and 1 placebo capsule
Arm Title
desloratadine
Arm Type
Active Comparator
Arm Description
5mg dose given as 1 5mg capsule and 1 placebo capsule
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
given as 2 placebo capsules
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Intervention Type
Drug
Intervention Name(s)
cetirizine
Intervention Type
Drug
Intervention Name(s)
desloratadine
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
change in methacholine pc20
Time Frame
change from baseline (pre dose) at 2 hours (post dose)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald W Cockcroft, MD
Organizational Affiliation
University of Saskatchewan, Department of Medicine, Division of Respirology, Critical Care and Sleep Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

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Anti-histamines and Methacholine Challenges.

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