Study of Bronchodilation Effects of Cetirizine

NCT01781507 | Completed Phase 4

• 1 other identifier: 00001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective : To compare the acute bronchodilatory effects of cetirizine 10 mg tablet and nebulized levalbuterol using impulse oscillometry technique in asthmatic subjects aged 18 to 65 years old who have allergic rhinitis and show clinical evidence of bronchial hyper-reactivity. Secondary Objective: To assess the bronchodilatory effects of cetirizine 10 mg tablet versus placebo after two weeks of therapy using impulse oscillometry technique in subjects 18 to 65 years old who have allergic rhinitis and show clinical evidence of bronchial hyper-reactivity.

Conditions

Allergic Rhinitis; Asthma

Keywords

Asthma; Allergic rhinitis; Cetirizine; Impulse oscillometry

Outcome Measures

Primary Outcomes (1)

• Change in impulse oscillometry result

  Impulse oscillometry measures airway resistance which is a reflection of dilation of the bronchial airways

  Baseline and after three weeks of study intervention

Study Arms (2)

Cetirizine

EXPERIMENTAL

Cetirizine 10 mg orally once a day

Drug: Cetirizine

Sugar pill

PLACEBO COMPARATOR

This will be the placebo arm

Drug: Placebo

Interventions

Cetirizine DRUG

Cetirizine is an antihistamine currently indicated for allergic rhinitis

Also known as: Zyrtec

Cetirizine

Placebo DRUG

This placebo ( sugar pill) will provide the negative control for this study

Also known as: Sugar pill

Sugar pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 to 65 years of age
• Physician diagnosis of mild asthma based on the NIH guidelines
• Physician diagnosis of allergic rhinitis and confirmed by at least 3+ skin test response to at least one allergen
• Evidence of abnormal, reversible airway function on impulse oscillometry
• Ability to cooperate in measurement of impulse oscillometry

You may not qualify if:

• Treatment with inhaled or oral corticosteroids within one month of screening visit
• Change in dosage of intranasal corticosteroids, or oral anti- leukotrienes within one month of screening visit. Subjects on constant dose of intranasal corticosteroids or anti-leukotrienes for one month or more will be allowed in the study.
• Known history of reflux, lung disease, or congenital heart disease
• Known history of adverse reaction to cetirizine

Sponsors & Collaborators

• California Allergy and Asthma Medical Group, Inc.: lead
• McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.: collaborator

Study Sites (1)

California Allergy and Asthma Medical Group

Los Angeles, California, 90025, United States

Location

Related Links

• American College of Allergy, Asthma and Immunology
• American Academy of Allergy Asthma and Immunology

MeSH Terms

Conditions

Rhinitis, Allergic; Asthma

Interventions

Cetirizine; Sugars

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; Carbohydrates

Study Officials

• Sheldon L Spector, MD

  California Allergy & Asthma Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: February 1, 2013
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 4, 2013

Record last verified: 2013-08

Locations

US (1)