The Effect of Desloratadine and Levocetirizine on Nasal Obstruction (Study P03609)
- 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
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 Safety All study visits 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)