The Effect of Desloratadine and Levocetirizine on Nasal Obstruction (Study P03609)(COMPLETED) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Allergic Rhinitis	Drug: desloratadine Drug: levocetirizine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Desloratadine Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]
Safety [ Time Frame: All study visits ] [ Designated as safety issue: Yes ]

Enrollment:	81
Study Start Date:	December 2003
Study Completion Date:	May 2004
Primary Completion Date:	May 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	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: 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	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®

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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, cromones, 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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00789152 History of Changes
Other Study ID Numbers:	P03609
Study First Received:	October 30, 2008
Last Updated:	November 7, 2008
Health Authority:	Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:

Nasal Obstruction
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Desloratadine
Loratadine
Levocetirizine
Cetirizine
Cholinergic Antagonists

Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Antipruritics
Dermatologic Agents
Therapeutic Uses
Anti-Allergic Agents

ClinicalTrials.gov processed this record on June 18, 2013