The Effect of Cetirizine on Bronchoconstriction
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|ClinicalTrials.gov Identifier: NCT03340740|
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : March 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis Asthma||Drug: Cetirizine Hydrochloride 1 MG/ML Drug: Placebo - Concentrate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, 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.|
|Official Title:||The Effect of Cetirizine on Bronchoconstriction in Patients With Allergic Rhinitis and Wheezing in the Pediatric Emergency Department|
|Actual Study Start Date :||May 11, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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
Cetirizine oral suspension
Placebo Comparator: Placebo
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
Similar-appearing liquid to cetirizine oral suspension
- 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.
- 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.
- Number of patients admitted to the hospital for inpatient management of wheezing [ Time Frame: At 3 hours ]Admission to hospital or discharge home
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340740
|Contact: Stephen Blumberg, MDfirstname.lastname@example.org|
|United States, New York|
|Jacobi Medical Center||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Stephen Blumberg, MD 718-918-5826 email@example.com|
|Contact: Katherine Huston, MD 718-918-5875 firstname.lastname@example.org|
|Principal Investigator:||Stephen Blumberg, MD||Jacobi Medical Center|