Allergic Rhinitis, Asthma
Conditions
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.
Interventions
DRUGCetirizine Hydrochloride 1 MG/ML
Cetirizine oral suspension
Similar-appearing liquid to cetirizine oral suspension
Sponsors
New York City Health and Hospitals Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The medication and placebo doses will be prepared in the pharmacy at the study site and provided to the investigators in deidentified bottles.
Eligibility
Sex/Gender
ALL
Age
6 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of patients admitted to the hospital for inpatient management of wheezing | At 3 hours | Admission to hospital or discharge home |
Countries
United States
Outcome results
None listed