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
NCT00637611 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1010
Last updated 2011-01-12
Summary
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
Conditions
- Seasonal Allergic Rhinitis
Interventions
- DRUG
-
Fexofenadine HCl
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Phyllis Diener · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-02-28
- Completion
- 2003-04-30
Countries
- United States
Study Locations
More Related Trials
-
A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)
NCT00960141 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. vs. Placebo for Treating Seasonal Allergic Rhinitis (SAR)(Study P04053)(COMPLETED)
NCT00783211 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma
NCT00044811 ·Status: COMPLETED ·Phase: PHASE3
-
Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine
NCT00637585 ·Status: COMPLETED ·Phase: PHASE4
-
The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)
NCT00092118 ·Status: COMPLETED ·Phase: PHASE3
-
Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)
NCT00972738 ·Status: COMPLETED ·Phase: PHASE3
-
Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis
NCT01306721 ·Status: COMPLETED ·Phase: PHASE3
-
Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
NCT00502775 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients
NCT01640535 ·Status: COMPLETED ·Phase: PHASE3
-
Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
NCT00435461 ·Status: COMPLETED ·Phase: PHASE4
-
A Study Assessing the Safety and Effectiveness of FEX60/PE10 Fixed Combination Tablet in Patients With Allergic Rhinitis
NCT02401191 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis
NCT00542607 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)
NCT01469234 ·Status: COMPLETED ·Phase: PHASE4
-
Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)
NCT00963469 ·Status: COMPLETED ·Phase: PHASE3
-
Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)
NCT00974571 ·Status: COMPLETED ·Phase: PHASE3
-
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study Designed to Evaluate the Efficacy of Fexofenadine HCl 180 mg for Preventing and Controlling Cat Allergy Symptoms
NCT00637884 ·Status: COMPLETED ·Phase: PHASE4
-
Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)
NCT03879772 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma
NCT00044824 ·Status: COMPLETED ·Phase: PHASE3
-
Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel
NCT00637455 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis
NCT00488176 ·Status: UNKNOWN ·Phase: PHASE4
-
The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis
NCT01033396 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. vs. Placebo for Treating Seasonal Allergic Rhinitis (SAR) (Study P04054)
NCT00783146 ·Status: COMPLETED ·Phase: PHASE4
-
Randomized, Placebo Controlled, Crossover Study in an Environmental Challenge Chamber to Assess Safety & Efficacy of Three Oral Doses of BI 671800 Versus Fluticasone Propionate and Montelukast in Sensitive Seasonal Allergic Rhinitis Patients Out of Season
NCT01007721 ·Status: COMPLETED ·Phase: PHASE2
-
MK0476 Study in Adult Patients With Allergic Rhinitis (0476-378)
NCT00446186 ·Status: COMPLETED ·Phase: PHASE2
-
An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)
NCT00127647 ·Status: COMPLETED ·Phase: PHASE3