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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Rhinitis Seasonal

Treatments: Drug: fexofenadine HCL (M016455); Drug: pseudoephedrine; Drug: fexofenadine HCL matching placebo; Drug: pseudoephedrine matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01306721

U1111-1115-7613 (Other Identifier)

EFC11243

Details and patient eligibility

About

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.

Full 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

Enrollment: 520 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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520 participants in 3 patient groups

FEX 60 mg

Active Comparator group

Description:

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)

Treatment:

Drug: fexofenadine HCL matching placebo

Drug: pseudoephedrine matching placebo

Drug: fexofenadine HCL (M016455)

Drug: pseudoephedrine

FEX 60 mg/PSE 60 mg

Experimental group

Description:

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)

Treatment:

Drug: fexofenadine HCL matching placebo

Drug: pseudoephedrine matching placebo

Drug: fexofenadine HCL (M016455)

Drug: pseudoephedrine

FEX 60 mg/PSE 120 mg

Experimental group

Description:

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

Treatment:

Drug: fexofenadine HCL matching placebo

Drug: fexofenadine HCL (M016455)

Drug: pseudoephedrine