Table 2.
Composition of the most frequently used primary end-point scores for AIT Phase III studies: CSMS and TCS.
| A) Symptom Score: CSMS + TCS | |
|---|---|
| Conjunctival Symptoms | Grittya feeling/itchy/red eyes |
| Watery eyes | |
| Nasal Symptoms | Blocked nose |
| Runny nose | |
| Itchy nose | |
| Sneezing | |
|
Each of the 6 symptoms will be scored using a 4-point severity scale 0 = No symptoms 1 = Mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated) 2 = Moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable) 3 = Severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). | |
| B) Medication Score: Combined Symptom Medication Score (CSMS) | ||
|---|---|---|
| Step | Relief medication | Score |
| No relief medications used | 0 | |
| 1 | Oral antihistamine/Ocular antihistamine | 1 |
| 2 | Intranasal corticosteroid with Step 1 medication(s) | 2 |
| 3 | Oral corticosteroids with Step 1 and Step 2 medications | 3 |
| Maximum daily Medication Score (dMS) | 3 | |
| C) Medication Score: Total Combined Score (TCS) | |
|---|---|
| Relief medication | Score |
| No relief medications used | 0 |
| Oral antihistamine | Each tablet taken corresponds to a score of 6 with a maximum daily score of 6 |
| Ocular antihistamine | Each drop corresponds to a score of 1.5 per eye with a maximum daily score of 6 |
| Intranasal corticosteroid | Each spray corresponds to a score of 2 with a maximum daily score of 8 |
| Maximum daily Medication Score (dMS) | 20 |
a
Gritty feeling is only applicable for the definition of TCS. CSMS = combined symptom medication score; TCS = total combined score