The Effect of Cetirizine on Bronchoconstriction

Phase 4

Completed

• Conditions: Allergic Rhinitis; Asthma
• Interventions: Drug: Cetirizine Hydrochloride 1 MG/ML; Drug: Placebo - Concentrate

• Registration Number: NCT03340740
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Study Start: 2018-05-11
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-16
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cetirizine	Cetirizine Hydrochloride 1 MG/ML	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.
Placebo	Placebo - Concentrate	Placebo 10ml (patients age 12-17) or 5ml (patients age 6-11) x 1 dose at beginning of course in the emergency department.

Primary Outcome Measures

Name	Time	Method
Change in Pulmonary Index Score between baseline and 3 hours	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

Name	Time	Method
Change in FEV1 between baseline and 3 hours	At baseline and at 3 hours	FEV 1 will be measured using a commercially-available spirometry device.

Trial Locations

Locations (1)

Jacobi Medical Center; 🇺🇸 Bronx, New York, United States