Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis

A Randomized, Double Blind, Parallel Group Study for Assessing the Efficacy and Safety of a Twice-daily Fexofenadine HCl 60 mg - Pseudoephedrine HCl 60 mg Combination or Fexofenadine HCl 60 mg - Pseudoephedrine HCl 120 mg Combination Versus Allegra® 60 mg in Patients With Seasonal Allergic Rhinitis

Primary Objective:

- To evaluate the efficacy on the nasal congestion of a twice-daily fexofenadine HCl 60 mg - pseudoephedrine HCl 60 mg combination (FEX60/PSE60) and fexofenadine HCl 60 mg - pseudoephedrine HCl 120 mg combination (FEX60/PSE120) versus fexofenadine HCl 60 mg (FEX60) in patients with seasonal allergic rhinitis (SAR).

Secondary Objectives:

• To evaluate the efficacy of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60 on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), eye symptom, and daily activity impairment.
• To assess the safety of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60.

Study Overview

• Status: Completed
• Conditions: Rhinitis Seasonal
• Intervention / Treatment: Drug: fexofenadine HCL (M016455); Drug: pseudoephedrine; Drug: fexofenadine HCL matching placebo; Drug: pseudoephedrine matching placebo

Detailed Description

The study duration for each patient is 3 weeks and 3 days:

1. Lead-in period: 1 week
2. Treatment period: 2 weeks
3. Follow-up period: 3 days

• Study Type: Interventional
• Enrollment (Actual): 520
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Koganei-Shi, Japan
    • Investigational Site Number 392002
  • Osaka-Shi, Japan
    • Investigational Site Number 392003
  • Shinjuku-Ku, Japan
    • Investigational Site Number 392001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

- Patients with seasonal allergic rhinitis (SAR): Patients with a history of SAR symptoms during the season when cedar pollen levels are increased for at least 2-years

Exclusion criteria:

• At the start of the placebo lead-in period:

  • Patients who are negative for IgE Antibody test
  • Expected nasal congestion score is less than 2

• The last 3 days of the lead-in period:

  • Nasal congestion scores are 2 or more and not all 4
  • Patients with all nasal symptoms (sneezing, rhinorrhea, and nasal congestion). A total score for nasal symptoms (sneezing, rhinorrhea, and nasal congestion) and eye symptom is less than 6
  • Patients with 2 or more nasal symptoms (sneezing and rhinorrhea) and eye symptoms score is 4

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FEX 60 mg; Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) Double-blind treatment period: 1 tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg /pseudoephedrine 60 mg (fixe dose combination)	Drug: fexofenadine HCL (M016455); Pharmaceutical form:tablet Route of administration: oral; Drug: pseudoephedrine; Pharmaceutical form:tablet Route of administration: oral; Drug: fexofenadine HCL matching placebo; Pharmaceutical form:tablet Route of administration: oral; Drug: pseudoephedrine matching placebo; Pharmaceutical form:tablet Route of administration: oral
Experimental: FEX 60 mg/PSE 60 mg; Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination Double-blind treatment period: 1 tablet of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 60 mg / pseudoephedrine 60 mg (fixe dose combination)	Drug: fexofenadine HCL (M016455); Pharmaceutical form:tablet Route of administration: oral; Drug: pseudoephedrine; Pharmaceutical form:tablet Route of administration: oral; Drug: fexofenadine HCL matching placebo; Pharmaceutical form:tablet Route of administration: oral; Drug: pseudoephedrine matching placebo; Pharmaceutical form:tablet Route of administration: oral
Experimental: FEX 60 mg/PSE 120 mg; Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) Double-blind treatment period: 2 tablets of fexofenadine 30 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 30 mg	Drug: fexofenadine HCL (M016455); Pharmaceutical form:tablet Route of administration: oral; Drug: pseudoephedrine; Pharmaceutical form:tablet Route of administration: oral; Drug: fexofenadine HCL matching placebo; Pharmaceutical form:tablet Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in the nasal congestion score based on the patient's symptom diary	over 2 treatment weeks (from baseline to end of treatment)

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in the total score of 4 symptoms, each nasal symptom (sneezing, rhinorrhea, and nasal congestion) and eye symptom	over 2 treatment weeks (from baseline to end of treatment)
Changes in total score of 4 symptoms on a daily, day-time, and night-time bases	over 2 treatment weeks (from baseline to end of treatment)
Changes in each symptom (sneezing, rhinorrhea, nasal congestion, and eye symptoms) score and the daily activity impairment score	over 2 treatment weeks (from baseline to end of treatment)
Changes in each symptom score and the daily activity impairment score on a daily, day-time and night-time basis	over 2 treatment weeks (from baseline to end of treatment)
Nasal findings	over 2 treatment weeks (from baseline to end of treatment)
Patient's impression	over 2 treatment weeks (from baseline to end of treatment)
Patient's safety	over 2 treatment weeks (from baseline to end of treatment)

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: March 1, 2011
• First Submitted That Met QC Criteria: March 1, 2011
• First Posted (Estimate): March 2, 2011

Study Record Updates

• Last Update Posted (Estimate): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 12, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Central Nervous System Stimulants; Sympathomimetics; Histamine H1 Antagonists, Non-Sedating; Vasoconstrictor Agents; Nasal Decongestants; Ephedrine; Pseudoephedrine; Fexofenadine; Terfenadine
• Other Study ID Numbers: EFC11243; U1111-1115-7613 (Other Identifier: UTN)