Clinical trial NCT01306721: Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis Seasonal
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-03-02
Enrollment: 520
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in the nasal congestion score based on the patient's symptom diary
timeFrame: over 2 treatment weeks (from baseline to end of treatment)
Secondary outcomes:
measure: Changes in the total score of 4 symptoms, each nasal symptom (sneezing, rhinorrhea, and nasal congestion) and eye symptom
timeFrame: over 2 treatment weeks (from baseline to end of treatment)
measure: Changes in total score of 4 symptoms on a daily, day-time, and night-time bases
timeFrame: over 2 treatment weeks (from baseline to end of treatment)
measure: Changes in each symptom (sneezing, rhinorrhea, nasal congestion, and eye symptoms) score and the daily activity impairment score
timeFrame: over 2 treatment weeks (from baseline to end of treatment)
measure: Changes in each symptom score and the daily activity impairment score on a daily, day-time and night-time basis
timeFrame: over 2 treatment weeks (from baseline to end of treatment)
measure: Nasal findings
timeFrame: over 2 treatment weeks (from baseline to end of treatment)
measure: Patient's impression
timeFrame: over 2 treatment weeks (from baseline to end of treatment)
measure: Patient's safety
timeFrame: over 2 treatment weeks (from baseline to end of treatment)
Other outcomes:
Locations:
city: Koganei-Shi
country: Japan
facility: Investigational Site Number 392002
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392003
city: Shinjuku-Ku
country: Japan
facility: Investigational Site Number 392001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: