Study of Bronchodilation Effects of Cetirizine

This study has been completed.
Sponsor:
Collaborator:
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Information provided by (Responsible Party):
Sheldon Spector, MD, California Allergy and Asthma Medical Group, Inc.
ClinicalTrials.gov Identifier:
NCT01781507
First received: January 30, 2013
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
Asthma
Drug: Cetirizine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Bronchodilatory Effects of Cetirizine in Adults With Concomitant Allergic Rhinitis and Mild Asthma as Measured by Impulse Oscillometry.

Resource links provided by NLM:


Further study details as provided by California Allergy and Asthma Medical Group, Inc.:

Primary Outcome Measures:
  • Change in impulse oscillometry result [ Time Frame: Baseline and after three weeks of study intervention ] [ Designated as safety issue: No ]
    Impulse oscillometry measures airway resistance which is a reflection of dilation of the bronchial airways


Enrollment: 21
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetirizine
Cetirizine 10 mg orally once a day
Drug: Cetirizine
Cetirizine is an antihistamine currently indicated for allergic rhinitis
Other Name: Zyrtec
Placebo Comparator: Sugar pill
This will be the placebo arm
Drug: Placebo
This placebo ( sugar pill) will provide the negative control for this study
Other Name: Sugar pill

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781507

Locations
United States, California
California Allergy and Asthma Medical Group
Los Angeles, California, United States, 90025
Sponsors and Collaborators
California Allergy and Asthma Medical Group, Inc.
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Investigators
Principal Investigator: Sheldon L Spector, MD California Allergy & Asthma Medical Group
  More Information

Additional Information:
No publications provided

Responsible Party: Sheldon Spector, MD, Principal Investigator, California Allergy and Asthma Medical Group, Inc.
ClinicalTrials.gov Identifier: NCT01781507     History of Changes
Other Study ID Numbers: 00001
Study First Received: January 30, 2013
Last Updated: August 30, 2013
Health Authority: United States: New England Institutional Review Board

Keywords provided by California Allergy and Asthma Medical Group, Inc.:
Asthma
Allergic rhinitis
Cetirizine
Impulse oscillometry

Additional relevant MeSH terms:
Asthma
Rhinitis
Rhinitis, Allergic, Perennial
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Cetirizine
Anti-Allergic Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014