Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00637611

Purpose

The primary objective of this study is to determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo. Secondary objectives are to compare the safety and efficacy of fexofenadine hydrochloride 180 mg, montelukast sodium 10 mg, and placebo

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Drug: Fexofenadine HCl	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit (Study I)

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

Drug Information available for: Fexofenadine Montelukast sodium Fexofenadine hydrochloride Montelukast

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo in the treatment of subjects with moderately severe seasonal allergic rhinitis (SAR) in a controlled setting.

Enrollment:	1010
Study Start Date:	February 2003
Study Completion Date:	April 2003

Intervention Details:

Other Name: Allegra

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female subjects, 15 years of age or older
History of seasonal allergic rhinitis (SAR) during the fall pollen season, for at least the previous 2 years
History of having a positive response to antihistamines for symptoms of SAR
Must be skin test positive to ragweed within the last 15 months with at least a moderate reaction as defined by a wheal 7 mm greater than the diluent wheal after intradermal skin test or a wheal 5 mm greater than the diluent wheal after skin prick test. A skin test performed in the previous 15 months may be used to qualify the patient if it was performed at the investigator's site and recorded in the subject's medical record
All females must have negative urine pregnancy test at screening visit
Willing and able to adhere to visit schedules and all study requirements

Exclusion Criteria:

Clinically significant medical condition (such as cardiovascular, hepatic, neurologic, hematological, renal, gastrointestinal, endocrine, or other major systemic disease), which, in the judgment of the investigator, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult
Asthma that requires treatment with medication other than an inhaled, short-acting beta agonist or asthma that will be exacerbated by exposure to ragweed pollen
Pregnancy or breast-feeding
History of hypersensitivity to the study medications or to drugs with similar chemical structures
Nasal structural abnormalities, including large nasal polyps or marked septal deviation, that significantly interfere with nasal air flow
Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
Upper or lower respiratory infection within 14 days of the first priming visit
Diagnosis of sinusitis within 30 days of the first priming visit
Immunotherapy, except those on a constant dose of immunotherapy that will be maintained throughout the study
Treatment with any investigational drug in the last 30 days before study entry
Recent history of drug or alcohol abuse
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
Unlikelihood to comply with protocol such as those with uncooperative attitude or the inability to return for follow-up visits or to complete the study
Subjects who were randomized into this trial will not be eligible to participate in another fexofenadine hydrochloride 180 mg vs montelukast sodium 10 mg onset of action study (planned to be conducted in 2003)
Subjects who are research employees or relatives of study site staff involved in this study or those who have or will read the protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637611

Locations

United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Phyllis Diener

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00637611 History of Changes
Other Study ID Numbers:	M016455A_4149
Study First Received:	March 10, 2008
Last Updated:	January 11, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Fexofenadine
Terfenadine
Montelukast
Anti-Allergic Agents

Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012