The Effect of Cetirizine on Bronchoconstriction

NCT ID: NCT03340740

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-11
• Study Completion Date: 2021-08-30

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.

Conditions

Allergic Rhinitis; Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cetirizine Hydrochloride 1 MG/ML

Intervention Type: DRUG

Cetirizine oral suspension

Placebo

Placebo 10ml (patients age 12-17) or 5ml (patients age 6-11) x 1 dose at beginning of course in the emergency department.

Group Type: PLACEBO_COMPARATOR

Placebo - Concentrate

Intervention Type: DRUG

Similar-appearing liquid to cetirizine oral suspension

Interventions

Cetirizine Hydrochloride 1 MG/ML

Cetirizine oral suspension

Intervention Type: DRUG

Placebo - Concentrate

Similar-appearing liquid to cetirizine oral suspension

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York City Health and Hospitals Corporation

OTHER

Sponsor Role: lead

Responsible Party

Stephen M. Blumberg

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Blumberg, MD

Role: PRINCIPAL_INVESTIGATOR

Jacobi Medical Center

Locations

Jacobi Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

2017-8047

Identifier Type: -

Identifier Source: org_study_id