Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01307319 | Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies | PHASE3 | COMPLETED | 715 | — | — | Mar 1, 2011 | Aug 1, 2011 | Feb 20, 2015 | 45 | United States |
Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale: * 0 = absent (no sign/symptom present) * 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) * 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. Baseline was defined as the average AM and PM subject-reported rTNSS over the 4 days prior to randomization.
| Arm | Type | Description |
|---|---|---|
| BDP HFA 80 mcg/day | EXPERIMENTAL | Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. |
| BDP HFA 160 mcg/day | EXPERIMENTAL | Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. |
| Placebo nasal aerosol once daily | PLACEBO_COMPARATOR | Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days. |
| Name | Type | Description |
|---|---|---|
| BDP HFA | DRUG | BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm. |
| Placebo nasal aerosol | DRUG | Placebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period. |
Inclusion Criteria: * Male or female subjects 6 to 11 years of age, as of the Screening Visit (SV) * A documented history of SAR to a relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV). * A demonstrated sensitivity to at le...