Allergic Rhinitis Clinical Trial
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
NCT number | NCT00789152 |
Other study ID # | P03609 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | December 1, 2003 |
Est. completion date | May 1, 2004 |
Verified date | February 2022 |
Source | Organon and Co |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 81 |
Est. completion date | May 1, 2004 |
Est. primary completion date | May 1, 2004 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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 ß2-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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Organon and Co |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | ||
Secondary | Safety | All study visits |
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