A Phase 4 interventional study of Cetirizine Hydrochloride 1 MG/ML and Placebo - Concentrate in Allergic Rhinitis and Asthma, sponsored by New York City Health and Hospitals Corporation. Completed at 1 site in United States. Open to participants aged 6 Years to 20 Years. Per ClinicalTrials.gov, last updated 2022-10-18.
Sponsored by New York City Health and Hospitals Corporation · Phase 4, Interventional, and Treatment
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.
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.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's enrollment of 40 is below the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →New York City Health and Hospitals Corporation is the lead sponsor of 28 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Cetirizine Hydrochloride 1 MG/ML
Placebo 10ml (patients age 12-17) or 5ml (patients age 6-11) x 1 dose at beginning of course in the emergency department.
Drug: Placebo - Concentrate
Drug page: Cetirizine
Cetirizine oral suspension
Similar-appearing liquid to cetirizine oral suspension
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.
Time frame: At baseline and at 3 hours
Change in FEV1 between baseline and 3 hours
FEV 1 will be measured using a commercially-available spirometry device.
Time frame: At baseline and at 3 hours
Number of patients admitted to the hospital for inpatient management of wheezing
Admission to hospital or discharge home
Time frame: At 3 hours
Plan to share: No
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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cetirizine
New York City Health and Hospitals Corporation