Background
Methods
Study design and treatment
Score | Grade | Guideline |
---|---|---|
0 | None | No sign/symptom is evident |
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 during the challenge session |
Symptom | TNSS | TOSS | TSS |
---|---|---|---|
Runny nose (rhinorrhea) | X | X | |
Sneezing | X | X | |
Nasal itching | X | X | |
Itchy/red/gritty eye | X | X | |
Watery eyes | X | X |
Study participants
Assessments
Statistical analyses
Results
Participant demographics
Characteristics | Overall (n = 66) |
---|---|
Mean age in years (SD) | 35.0 (9.9) |
Female (%) | 39 (59) |
Race (%) | |
Caucasian | 64 (97) |
Black | 0 (0) |
Asian | 2 (3) |
American Indian/Alaska Native | 0 (0) |
Native Hawaiian/Other Pacific Islander | 0 (0) |
Other | 0 (0) |
Baseline symptom scores (SD)a | Loratadine (n = 66) | Placebo (n = 66) |
---|---|---|
TNSS | 6.9 (1.7) | 6.5 (1.8) |
TOSS | 4.0 (1.5) | 3.7 (1.7) |
TSS | 10.9 (2.6) | 10.2 (3.0) |
Onset of action outcome
Secondary efficacy outcomes
Safety
Loratadine (n = 68) | Placebo (n = 69) | |
---|---|---|
Number of participants reporting ≥ 1 AEs (%) | 7 (10) | 4 (6) |
Number of AEs reported | 12 | 5 |
Serious (%) | ||
No | 12 (100) | 5 (100) |
Yes | 0 (0) | 0 (0) |
Severity of AE (%) | ||
Mild | 4 (33) | 2 (40) |
Moderate | 8 (67) | 3 (60) |
Severe | 0 (0) | 0 (0) |
Possible relationship to study medication (%) | ||
Not possibly related | 11 (92) | 5 (100) |
Possibly related | 1 (8) | 0 (0) |