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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: Diphenhydramine Drug: cetirizine Drug: desloratadine Drug: placebo | Phase 4 |
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 |
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 |
- change in methacholine pc20 [ Time Frame: change from baseline (pre dose) at 2 hours (post dose) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Canada, Saskatchewan | |
University of Saskatchewan | |
Saskatoon, Saskatchewan, Canada, S7N 0W8 |
Principal Investigator: | Donald W Cockcroft, MD | University of Saskatchewan, Department of Medicine, Division of Respirology, Critical Care and Sleep Medicine |
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 |