Trial record 1 of 5 for:
Open Studies | "Histamine Antagonists"
Anti-histamines and Methacholine Challenges.
This study is not yet open for participant recruitment.
(see Contacts and Locations)
Verified November 2013 by University of Saskatchewan
Sponsor:
Don Cockcroft
Information provided by (Responsible Party):
Don Cockcroft, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01985789
First received: October 31, 2013
Last updated: November 8, 2013
Last verified: November 2013
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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 Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | The Effect of Antihistamines on Methacholine Challenge Testing in Asthma Patients |
Resource links provided by NLM:
Drug Information available for:
Promethazine hydrochloride
Diphenhydramine
Promethazine
Diphenhydramine hydrochloride
Cetirizine
Diphenhydramine citrate
Desloratadine
U.S. FDA Resources
Further study details as provided by University of Saskatchewan:
Primary Outcome Measures:
- change in methacholine pc20 [ Time Frame: change from baseline (pre dose) at 2 hours (post dose) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | November 2013 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01985789
Please refer to this study by its ClinicalTrials.gov identifier: NCT01985789
Contacts
| Contact: Beth Davis, PhD | 306-966-8291 | beth.davis@usask.ca |
Locations
| Canada, Saskatchewan | |
| University of Saskatchewan | Not yet recruiting |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| Contact: Beth Davis, PhD 306-966-8291 beth.davis@usask.ca | |
| Sub-Investigator: Beth E Davis, PhD | |
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
No publications provided
| Responsible Party: | Don Cockcroft, Professor, University of Saskatchewan |
| ClinicalTrials.gov Identifier: | NCT01985789 History of Changes |
| Other Study ID Numbers: | PHPY2013/14 |
| Study First Received: | October 31, 2013 |
| Last Updated: | November 8, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Saskatchewan:
|
airway hyperresponsiveness |
Additional relevant MeSH terms:
|
Desloratadine Diphenhydramine Anesthetics Anesthetics, Local Anti-Allergic Agents Antiemetics Autonomic Agents Central Nervous System Agents Central Nervous System Depressants Cholinergic Agents Cholinergic Antagonists Gastrointestinal Agents |
Histamine Agents Histamine Antagonists Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating Hypnotics and Sedatives Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015