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

Phase 3

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: desloratadine; Drug: levocetirizine

• Registration Number: NCT00789152
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12-01
• Primary Completion: 2004-05-01
• Study Completion: 2004-05-01
• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-11-07
• Study First Posted: 2008-11-11
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
levocetirizine followed by desloratadine	levocetirizine	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
levocetirizine followed by desloratadine	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
desloratadine followed by levocetirizine	desloratadine	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
desloratadine followed by levocetirizine	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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