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Completed

NCT Number: NCT03340740

The Effect of Cetirizine on Bronchoconstriction

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.

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Key information

Age range

6 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jacobi Medical Center

The Bronx, New York, 10461, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetirizine Hydrochloride 1 MG/ML

Drug

Cetirizine oral suspension

Placebo - Concentrate

Drug

Similar-appearing liquid to cetirizine oral suspension

Primary outcomes

  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 outcomes

  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 outcomes

  1. Number of patients admitted to the hospital for inpatient management of wheezing

    Time frame: At 3 hours

    Admission to hospital or discharge home

Sponsors and collaborators

Lead sponsor

New York City Health and Hospitals Corporation

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 13, 2017
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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