Clinical trial NCT00789152: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-11-11
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Total Nasal Symptom Score (TNSS) at the end of treatment phase compared to pre-exposure baseline scores
timeFrame: End of each treatment phase (8th day)
Secondary outcomes:
measure: 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)
timeFrame: End of each treatment phase (8th day)
measure: Safety
timeFrame: All study visits
Other outcomes:
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