Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Fexofenadine HCl New Formulation Tablet, Fexofenadine, Comparator = Montelukast, Fexofenadine, fexofenadine HCL (M016455), fexofenadine, Fexofenadine (loratadine if not available)
Fexofenadine New Formulation · 7 trials · 5 indications
TNSS-3=composite score calculated as sum of rhinorrhea, sneezing, and nasal itching scores (TNSS-3: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. Individual scores were collected in e-diary. AUC of TNSS from time of the first observation to time of the last observation (AUC \[0-6 hr\]) was calculated by using the linear trapezoid method. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-43.5; Arm B=2.1-39.9.
| Arm | Type | Description |
|---|---|---|
| Arm A (active-active) | EXPERIMENTAL | Two days of pre-treatment with Fexofenadine 180 mg each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4. |
| Arm B (placebo-active) | EXPERIMENTAL | Two days of pre-treatment with tablet of matching placebo each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4. |
| FEX 60 mg | ACTIVE_COMPARATOR | 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) |
| FEX 60 mg/PSE 60 mg | EXPERIMENTAL | 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) |
| FEX 60 mg/PSE 120 mg | EXPERIMENTAL | 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 |
| Age 6 months - 2 years | EXPERIMENTAL | Patients between 6 months and 2 years old - Type: Experimental |
| Age 2 - 11 years | EXPERIMENTAL | Patients between 2 and 11 years (and under 10.5 kg) |
| Age 2 - 11 years (and over 10.5 kg) | EXPERIMENTAL | Patients between 2 and 11 years (and over 10.5 kg) |
| Name | Type | Description |
|---|---|---|
| Fexofenadine | DRUG | Fexofenadine oral tablet |
| Placebo | DRUG | Fexofenadine matching placebo oral tablet |
| fexofenadine HCL (M016455) | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| pseudoephedrine | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| fexofenadine HCL matching placebo | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| pseudoephedrine matching placebo | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| Fexofenadine, Comparator = Montelukast | DRUG | - |
| fexofenadine/Allegra (M016455) | DRUG | Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral |
Inclusion Criteria: * Participants are eligible to be included in the study only if all of the following criteria apply: * Participant is willing to provide written informed consent. * Adult participants (18 to 80 years old) suffering from seasonal allergic rhinitis (SAR) provoked by Ragweed pollen...