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Study of Bronchodilation Effects of Cetirizine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01781507
First Posted: February 1, 2013
Last Update Posted: September 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Information provided by (Responsible Party):
Sheldon Spector, MD, California Allergy and Asthma Medical Group, Inc.
  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
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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 Sheldon Spector, MD, 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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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:
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
First Submitted: January 30, 2013
First Posted: February 1, 2013
Last Update Posted: September 4, 2013
Last Verified: August 2013

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

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