The Effect of Cetirizine on Bronchoconstriction

NCT03340740 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 2017-8047
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis; Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and at 3 hours

Secondary Outcomes (1)

• Change in FEV1 between baseline and 3 hours

  At baseline and at 3 hours

Other Outcomes (1)

• Number of patients admitted to the hospital for inpatient management of wheezing

  At 3 hours

Study Arms (2)

Cetirizine

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

Cetirizine Hydrochloride 1 MG/ML DRUG

Cetirizine oral suspension

Cetirizine

Placebo - Concentrate DRUG

Similar-appearing liquid to cetirizine oral suspension

Placebo

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• History of allergic rhinitis
• Wheezing

You may not qualify if:

• Use of antihistamine within the past 72 hours
• Chronic Pulmonary Condition other than asthma
• Other contraindication to cetirizine
• Severe asthma exacerbation requiring resuscitation

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Asthma

Interventions

Cetirizine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stephen Blumberg, MD

  Jacobi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The medication and placebo doses will be prepared in the pharmacy at the study site and provided to the investigators in deidentified bottles.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: November 13, 2017
• Study Start: May 11, 2018
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)