Study of Bronchodilation Effects of Cetirizine
Condition: Allergic Rhinitis; Asthma
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      OBJECTIVES:

      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.

      SUBJECT SELECTION:

      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

      METHODS:

      General Design:

      This study, is a double-blinded, randomized , placebo- controlled study to assess 1) the
      acute bronchodilatory effects of cetirizine 10 mg tablet compared to levalbuterol and 2) the
      bronchodilatory effect of cetirizine 10 mg compared to placebo after two weeks of treatment .
      There will be minimum of five total study visits. The study drug will be encapsulated with
      methylcellulose and the placebo capsules will have methylcellulose alone.

      Visit Schedule:

        1. Initial Screening Visit On a regularly scheduled clinic day, following completion of a
           signed informed consent the study, the first patient evaluation will compose of: '

           History and Physical Exam The subject's demographic, medical, family, and history will
           be recorded by standardized questionnaire. All previous medications used to treat
           allergic rhinitis will be recorded.

           Skin prick testing using the Multi-test method will be used to test for common
           environmental allergens. This is a standard procedure done in evaluating patients with a
           clinical history suggestive of allergic rhinitis and takes 15 minutes from initial prick
           to interpretation of results.

           As part of the standard assessment for skin testing, patients will be asked to not take
           any oral or intranasal anti-histamines for one week before the visit. Antihistamines can
           mask the histamine effects, and subsequently positive skin test results. If they are
           interested in participating in the study, they will be asked to remain off
           antihistamines until their enrollment into the study has been determined. Allergens on
           the environmental panel to be tested include cat, dust mite, weed mix, tree mix, grass
           mix, mold mix, saline, and histamine.

        2. Second Screening Visit

           After withholding beta-agonist treatment for at least 6 hours, testing for baseline
           pulmonary function will be performed with impulse oscillometry and spirometry. They will
           undergo impulse oscillometry technique under the guidance of a trained technician. If
           the subject is.able to, he/she will also perform spirometry after oscillometry is
           completed. If airway obstruction is detected by oscillometry, subjects will be given
           levalbuterol by hand-held nebulizer and both impulse oscillometry and spirometry will be
           repeated 15 minutes after the nebulizer treatment is completed. If there is evidence of
           reversibility (i.e. lung function improvement), then the subject will have fulfilled the
           inclusion criteria and be asked to continue with the study.

        3. First Study Visit The first study visit will be a continuation of the second screening
           visit after the subject has fulfilled the inclusion criteria as evidenced by reversible
           airway obstruction following levalbuterol treatment. The subject will be asked to
           continue with the study period and he/she will have repeat lung function testing at 15,
           30, 60,90, 120, 180, and 240 minutes after treatment. Lung function testing will be by
           impulse oscillometry. If the subject is able to, he/she will perform spirometry at 60
           and 240 minutes post-levalbuterol.

           Subjects will be instructed to complete a daily diary for allergic rhinitis and asthma
           symptom scores.

        4. Second Study Visit (1 to 7 days after First Study Visit) All beta-agonist treatment
           needs to be withheld at least 6 hours prior to the visit. Baseline lung function testing
           by impulse oscillometry and spirometry will be done. The subject will be given
           Cetirizine 10 mg tablet or placebo. The subject and the coordinator will be blinded to
           the study treatment. Lung function testing will be assessed by impulse oscillometry. at
           15, 30, 60, 90, 120, 180, and 240 minutes after the cetirizine. Spirometry will also be
           performed at 60 and 240 minutes post.-cetirizine .

           Daily diary entries will be reviewed with the subject. The subject will be sent home on
           the study medication. He/she take 1 tablet of the study medication daily starting the
           day after the study visit.

        5. Third Study Visit (7 to 10 days after Second Study Visit) The subject will take his/her
           usual study medication dose in the office. He/she will perform impulse oscillometry, and
           if able to, spirometry to assess lung function. Daily diary entries will be reviewed
           with subject. The subject will be instructed to continue taking the study medication at
           the same dosing regimen.

        6. Fourth Study Visit ,(7 to 10 days after Third Study Visit)

           The subject will take his/her usual study medication dose in the office. He/she will
           perform impulse oscillometry and spirometry to assess lung function. Daily diary entries
           will be reviewed with the subject. The subject will be instructed to stop taking the
           study medication and continue putting in diary entries.

        7. Fifth Study Visit (7 to 10 days after Fourth Study Visit) The subject will perform
           impulse oscillometry and spirometry to assess lung function. Daily diary entries will be
           reviewed with the parent or caregiver.

      Laboratory Studies:

      There will be no laboratory studies in this project.
    

Intervention name(s): Cetirizine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cetirizine is an antihistamine currently indicated for allergic rhinitis; This placebo ( sugar pill) will provide the negative control for this study
Other intervention name(s): Zyrtec; Sugar pill
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Allergic rhinitis; Cetirizine; Impulse oscillometry