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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00789152
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):

October 30, 2008
November 11, 2008
March 24, 2017
December 1, 2003
May 1, 2004   (Final data collection date for primary outcome measure)
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) ]
Same as current
Complete list of historical versions of study NCT00789152 on ClinicalTrials.gov Archive Site
  • 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) ]
  • Safety [ Time Frame: All study visits ]
Same as current
Not Provided
Not Provided
 
The Effect of Desloratadine and Levocetirizine on Nasal Obstruction (Study P03609)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Allergic Rhinitis
  • Drug: desloratadine
    desloratadine 5 mg daily x 8 days
    Other Name: Clarinex, SCH 034117
  • Drug: levocetirizine
    levocetirizine 5 mg daily x 8 days
    Other Name: XYZAL®
  • Experimental: desloratadine followed by 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
    Interventions:
    • Drug: desloratadine
    • Drug: levocetirizine
  • Experimental: levocetirizine followed by 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
    Interventions:
    • Drug: desloratadine
    • Drug: levocetirizine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
May 1, 2004
May 1, 2004   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00789152
P03609
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP