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

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

desloratadine

levocetirizine

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

desloratadine followed by levocetirizine

levocetirizine followed by desloratadine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Total Nasal Symptom Score (TNSS) at the end of treatment phase compared to pre-exposure baseline scores

Secondary Outcome Measures

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)

Safety

Full Information

NCT ID

NCT00789152

First Posted

October 30, 2008

Last Updated

February 7, 2022

Sponsor

Organon and Co

1. Study Identification

Unique Protocol Identification Number

NCT00789152

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

December 1, 2003 (Actual)

Primary Completion Date

May 1, 2004 (Actual)

Study Completion Date

May 1, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organon and Co

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

desloratadine followed by levocetirizine

Arm Type

Experimental

Arm Description

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

Arm Title

levocetirizine followed by desloratadine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

desloratadine

Other Intervention Name(s)

Clarinex, SCH 034117

Intervention Description

desloratadine 5 mg daily x 8 days

Intervention Type

Drug

Intervention Name(s)

levocetirizine

Other Intervention Name(s)

XYZAL®

Intervention Description

levocetirizine 5 mg daily x 8 days

Primary Outcome Measure Information:

Title

Change in Total Nasal Symptom Score (TNSS) at the end of treatment phase compared to pre-exposure baseline scores

Time Frame

End of each treatment phase (8th day)

Secondary Outcome Measure Information:

Title

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)

Time Frame

End of each treatment phase (8th day)

Title

Safety

Time Frame

All study visits

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Available IPD and Supporting Information:

Available IPD/Information Type

CSR Synopsis

Available IPD/Information URL

http://www.merck.com/clinical-trials/policies-perspectives.html

Learn more about this trial

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

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