The Effect of Cetirizine on Bronchoconstriction

New York City Health and Hospitals Corporation

Status and phase: Completed; Phase 4

Conditions: Asthma; Allergic Rhinitis

Treatments: Drug: Placebo - Concentrate; Drug: Cetirizine Hydrochloride 1 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT03340740

2017-8047

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 6 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Cetirizine

Experimental group

Description:

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.

Treatment:

Drug: Cetirizine Hydrochloride 1 MG/ML

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo - Concentrate