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Anti-histamines and Methacholine Challenges.

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ClinicalTrials.gov Identifier: NCT01985789
Recruitment Status : Completed
First Posted : November 15, 2013
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
Don Cockcroft, University of Saskatchewan

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Diphenhydramine Drug: cetirizine Drug: desloratadine Drug: placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Effect of Antihistamines on Methacholine Challenge Testing in Asthma Patients
Study Start Date : November 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. change in methacholine pc20 [ Time Frame: change from baseline (pre dose) at 2 hours (post dose) ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Don Cockcroft, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01985789     History of Changes
Other Study ID Numbers: PHPY2013/14
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 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
Diphenhydramine
Promethazine
Desloratadine
Cetirizine
Methacholine Chloride
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anti-Allergic Agents