The Effect of Cetirizine on Bronchoconstriction
Primary Purpose
Allergic Rhinitis, Asthma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cetirizine Hydrochloride 1 MG/ML
Placebo - Concentrate
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
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
Sites / Locations
- Jacobi Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cetirizine
Placebo
Arm 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.
Placebo 10ml (patients age 12-17) or 5ml (patients age 6-11) x 1 dose at beginning of course in the emergency department.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in FEV1 between baseline and 3 hours
FEV 1 will be measured using a commercially-available spirometry device.
Full Information
NCT ID
NCT03340740
First Posted
October 4, 2017
Last Updated
October 16, 2022
Sponsor
New York City Health and Hospitals Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03340740
Brief Title
The Effect of Cetirizine on Bronchoconstriction
Official Title
The Effect of Cetirizine on Bronchoconstriction in Patients With Allergic Rhinitis and Wheezing in the Pediatric Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 11, 2018 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York City Health and Hospitals Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cetirizine
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 10ml (patients age 12-17) or 5ml (patients age 6-11) x 1 dose at beginning of course in the emergency department.
Intervention Type
Drug
Intervention Name(s)
Cetirizine Hydrochloride 1 MG/ML
Intervention Description
Cetirizine oral suspension
Intervention Type
Drug
Intervention Name(s)
Placebo - Concentrate
Intervention Description
Similar-appearing liquid to cetirizine oral suspension
Primary Outcome Measure Information:
Title
Change in Pulmonary Index Score between baseline and 3 hours
Description
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
Secondary Outcome Measure Information:
Title
Change in FEV1 between baseline and 3 hours
Description
FEV 1 will be measured using a commercially-available spirometry device.
Time Frame
At baseline and at 3 hours
Other Pre-specified Outcome Measures:
Title
Number of patients admitted to the hospital for inpatient management of wheezing
Description
Admission to hospital or discharge home
Time Frame
At 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Blumberg, MD
Organizational Affiliation
Jacobi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Cetirizine on Bronchoconstriction
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