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

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: desloratadine; Drug: levocetirizine

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)
Safety	All study visits

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2003
• Primary Completion (Actual): May 1, 2004
• Study Completion (Actual): May 1, 2004

Study Registration Dates

• First Submitted: October 30, 2008
• First Submitted That Met QC Criteria: November 7, 2008
• First Posted (Estimated): November 11, 2008

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Rhinitis; Rhinitis, Allergic; Nasal Obstruction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Antagonists; Cholinergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Levocetirizine; Desloratadine
• Other Study ID Numbers: P03609

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis