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The Effect of Cetirizine on Bronchoconstriction

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ClinicalTrials.gov Identifier: NCT03340740
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Stephen M. Blumberg, New York City Health and Hospitals Corporation

Brief Summary:
The purpose of this study is to determine the effect of cetirizine, an oral antihistamine, on wheezing in patients with allergic rhinitis. Patients presenting to the pediatric emergency department who have a history of allergic rhinitis and who are wheezing will be asked to participate. Half of patients will receive a dose of cetirizine and the other half will receive placebo and their response will be monitored over the course of their emergency department visit with vital signs, physical examinations, and measurement of bronchoconstriction with spirometry.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Asthma Drug: Cetirizine Hydrochloride 1 MG/ML Drug: Placebo - Concentrate Phase 4

Detailed Description:
This is a prospective randomized, placebo-controlled trial to look at the effect of cetirizine on bronchoconstriction in patients with allergic rhinitis who present to the Pediatric Emergency Department with wheezing. Oral second generation antihistamines such as cetirizine are already the standard of care for allergic rhinitis. Wheezing pediatric patients with allergic rhinitis who are not already on this therapy will be randomized to receive either age-appropriate-dosed cetirizine or placebo in addition to standard asthma therapy at the discretion of the treating clinician, and will be monitored every 30 minutes with asthma scores and FEV1 measurements. At the conclusion of 3 hours, each patient who received placebo will receive a dose of cetirizine, and each patient who received cetirizine will receive a placebo medication dose, such that initiating therapy for allergic rhinitis is delayed by no more than 3 hours.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The medication and placebo doses will be prepared in the pharmacy at the study site and provided to the investigators in deidentified bottles.
Primary Purpose: Treatment
Official Title: The Effect of Cetirizine on Bronchoconstriction in Patients With Allergic Rhinitis and Wheezing in the Pediatric Emergency Department
Actual Study Start Date : May 11, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cetirizine
Cetirizine 10mg (10ml) (patients age 12-17) or cetirizine 5mg (5ml) (patients age 6-11) x 1 dose at beginning of course in emergency department.
Drug: Cetirizine Hydrochloride 1 MG/ML
Cetirizine oral suspension

Placebo Comparator: Placebo
Placebo 10ml (patients age 12-17) or 5ml (patients age 6-11) x 1 dose at beginning of course in the emergency department.
Drug: Placebo - Concentrate
Similar-appearing liquid to cetirizine oral suspension




Primary Outcome Measures :
  1. Change in Pulmonary Index Score between baseline and 3 hours [ Time Frame: At baseline and at 3 hours ]
    A composite score on a scale of 0-14, comprised of respiratory rate, wheezing, inspiration/expiration ratio, accessory muscle use and oxygen saturation.


Secondary Outcome Measures :
  1. Change in FEV1 between baseline and 3 hours [ Time Frame: At baseline and at 3 hours ]
    FEV 1 will be measured using a commercially-available spirometry device.


Other Outcome Measures:
  1. Number of patients admitted to the hospital for inpatient management of wheezing [ Time Frame: At 3 hours ]
    Admission to hospital or discharge home



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Ages Eligible for Study:   6 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of allergic rhinitis
  • Wheezing

Exclusion Criteria:

  • Use of antihistamine within the past 72 hours
  • Chronic Pulmonary Condition other than asthma
  • Other contraindication to cetirizine
  • Severe asthma exacerbation requiring resuscitation

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): NCT03340740


Contacts
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Contact: Stephen Blumberg, MD 718-918-7548 stephen.blumberg@nychhc.org

Locations
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United States, New York
Jacobi Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Stephen Blumberg, MD    718-918-5826    stephen.blumberg@nychhc.org   
Contact: Katherine Huston, MD    718-918-5875    hustonk@nychhc.org   
Sponsors and Collaborators
New York City Health and Hospitals Corporation
Investigators
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Principal Investigator: Stephen Blumberg, MD Jacobi Medical Center

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Responsible Party: Stephen M. Blumberg, Primary Investigator, New York City Health and Hospitals Corporation
ClinicalTrials.gov Identifier: NCT03340740     History of Changes
Other Study ID Numbers: 2017-8047
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs