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Anti-histamines and Methacholine Challenges.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01985789
First Posted: November 15, 2013
Last Update Posted: April 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Don Cockcroft, University of Saskatchewan
  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: Triple (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:


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

Information from the National Library of Medicine

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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
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

Responsible Party: Don Cockcroft, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01985789     History of Changes
Other Study ID Numbers: PHPY2013/14
First Submitted: October 31, 2013
First Posted: November 15, 2013
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