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The Effect of Desloratadine and Levocetirizine on Nasal Obstruction (Study P03609)

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00789152
Collaborator
(none)
81
Enrollment
2
Arms
5
Actual Duration (Months)

Study Details

Study Description

Brief Summary

This was a study to measure the ability of desloratadine and levocetirizine to decrease nasal obstruction in subjects who had study-induced allergic rhinitis. Study participants had allergic rhinitis symptoms induced in a Vienna Challenge Chamber and then received desloratadine or levocetirizine for 8 days. After at least a 10 to 35-day washout period (time when no drug is given), subjects received the opposite treatment for 8 days. Subjects had their total nasal symptom measured.on the 8th day of each treatment period.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
81 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effects of Desloratadine and Levocetirizine on Nasal Obstruction in Subjects With Induced Allergic Rhinitis in the VCC Assessed Clinically and With Nasal Rhinomanometry and Nasal Flowmetry
Actual Study Start Date :
Dec 1, 2003
Actual Primary Completion Date :
May 1, 2004
Actual Study Completion Date :
May 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: desloratadine followed by levocetirizine

Subjects in this arm received desloratadine 5 mg daily for 8 days, followed by 10 day washout period, then followed by levocetirizine 5 mg daily for 8 days

Drug: desloratadine
desloratadine 5 mg daily x 8 days
Other Names:
  • Clarinex, SCH 034117

    • Drug: levocetirizine
    levocetirizine 5 mg daily x 8 days
    Other Names:
  • XYZAL®

    		•
    Experimental: levocetirizine followed by desloratadine

    Subjects in this arm received levocetirizine 5 mg daily for 8 days, followed by 10 day washout period, then followed by desloratadine 5 mg daily for 8 days

    Drug: desloratadine
    desloratadine 5 mg daily x 8 days
    Other Names:
  • Clarinex, SCH 034117

    • Drug: levocetirizine
    levocetirizine 5 mg daily x 8 days
    Other Names:
  • XYZAL®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Total Nasal Symptom Score (TNSS) at the end of treatment phase compared to pre-exposure baseline scores [End of each treatment phase (8th day)]

    Secondary Outcome Measures

    1. Nasal Peak Inspiratory Flow (NPIF), Nasal secretion weights, nasal airflow, individual nasal symptoms, TNSS, Total Non-Nasal Symptoms Severity Score (TNNSS), Total Symptom Score (TSS) [End of each treatment phase (8th day)]

    2. Safety [All study visits]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 to 45 years of age

    • Were free of any clinically significant disease that would interfere with study evaluations.

    • Demonstrated hypersensitivity to the grass allergen used in the chamber unless confirmed previously within 12 months.

    • Hypersensitivity to the allergen was documented by a positive response to the skin prick test with a wheal diameter at least 3 mm larger than the diluent control and by a radioallergosorbent test (RAST) class of >=2 (rating scale 0 -6).

    • Had a history of SAR for at least 2 years, as diagnosed by the investigator, another physician, or subject-provided history.

    • Reported having shown therapeutic efficacy with previous use of an antihistamine (without a decongestant).

    • At the screening allergen provocation, the subject had a nasal obstruction symptom severity score of at least moderate (>=2) and a decrease from baseline in nasal airflow (mL/sec) measured by rhinomanometry of >=30% within 2 hours of allergen exposure. Also, the subject had a nasal obstruction symptom severity score of none or mild (<=1) prior to exposure to allergen.

    Exclusion Criteria:

    • Women who were pregnant or nursing.

    • Had a body mass index (BMI) >=30 kg/m^2.

    • Had asthma; were being treated with inhaled or oral corticosteroids, chromones, theophylline, leukotriene inhibitors, or short-acting inhaled β2-agonists (except during or immediately after the allergen exposures); and could not go through the washout periods and the entire study without needing these medications.

    • Developed wheezing or dyspnea during the screening allergen exposure.

    • Had a respiratory infection during the 4 weeks prior to pre-dose evaluations.

    • Had any clinically significant deviation from normal in the physical examination that, in the investigator's judgment, could interfere with the study evaluation or affect subject safety.

    • Had any history of or laboratory evidence of hepatic failure or renal failure with a glomerular filtration rate (GFR) known to be <30 mL/min.

    • Had a known potential for hypersensitivity, allergic, or idiosyncratic reaction to the study drug or excipients.

    • Had nasal structural abnormalities, including large nasal polyps and marked septum deviation, that significantly interfered with nasal airflow.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT00789152
    Other Study ID Numbers:
    • P03609
    First Posted:
    Nov 11, 2008
    Last Update Posted:
    Feb 16, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Rhinitis
    Rhinitis, Allergic
    Nasal Obstruction
    Levocetirizine
    Desloratadine

    Study Results

    No Results Posted as of Feb 16, 2022