Status:
COMPLETED
The Effect of Desloratadine and Levocetirizine on Nasal Obstruction (Study P03609)
Lead Sponsor:
Organon and Co
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18-45 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00789152
Start Date
December 1 2003
End Date
May 1 2004
Last Update
August 15 2024
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