Rhinitis Seasonal
Conditions
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
Interventions
DRUGfexofenadine HCL (M016455)
Pharmaceutical form:tablet Route of administration: oral
DRUGpseudoephedrine
Pharmaceutical form:tablet Route of administration: oral
DRUGfexofenadine HCL matching placebo
Pharmaceutical form:tablet Route of administration: oral
DRUGpseudoephedrine matching placebo
Pharmaceutical form:tablet Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
| 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) |
| Nasal findings | over 2 treatment weeks (from baseline to end of treatment) |
Countries
Japan
Outcome results
None listed