The Effect of Cetirizine on Bronchoconstriction

Asthma Clinical Trial

Official title:

The Effect of Cetirizine on Bronchoconstriction in Patients With Allergic Rhinitis and Wheezing in the Pediatric Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340740
• Other study ID #: 2017-8047
• Status: Completed
• Phase: Phase 4
• Start date: May 11, 2018
• Est. completion date: August 30, 2021

Study information

• Verified date: October 2022
• Source: New York City Health and Hospitals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Cetirizine Hydrochloride 1 MG/ML
Cetirizine oral suspension
• Placebo - Concentrate
Similar-appearing liquid to cetirizine oral suspension

Locations

Country	Name	City	State
United States	Jacobi Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York City Health and Hospitals Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients admitted to the hospital for inpatient management of wheezing	Admission to hospital or discharge home	At 3 hours
Primary	Change in Pulmonary Index Score between baseline and 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.	At baseline and at 3 hours
Secondary	Change in FEV1 between baseline and 3 hours	FEV 1 will be measured using a commercially-available spirometry device.	At baseline and at 3 hours