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

NCT00789152 | Completed Phase 3

• 1 other identifier: P03609
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• 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

Study Arms (2)

desloratadine followed by levocetirizine

EXPERIMENTAL

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; Drug: levocetirizine

levocetirizine followed by desloratadine

EXPERIMENTAL

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; Drug: levocetirizine

Interventions

desloratadine DRUG

desloratadine 5 mg daily x 8 days

Also known as: Clarinex, SCH 034117

desloratadine followed by levocetirizine; levocetirizine followed by desloratadine

levocetirizine DRUG

levocetirizine 5 mg daily x 8 days

Also known as: XYZAL®

desloratadine followed by levocetirizine; levocetirizine followed by desloratadine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

desloratadine; levocetirizine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: November 11, 2008
• Study Start: December 1, 2003
• Primary Completion: May 1, 2004
• Study Completion: May 1, 2004
• Last Updated: August 15, 2024

Record last verified: 2022-02