| Study 1 | Study 2 | Study 3 | Study 4 |
Study Identifier | Impact 0288 | Impact 0048 | Impact 11764 | Impact 13700 |
Year | 1997-1998 | 1998-1999 | 2005-2007 | 2009-2012 |
Country | United States | United States | Italy, Poland, Slovenia, United States | United Kingdom |
Publication | Loose and Winkler (2004) [25] | Schachtel et al. (2010) [26] | Bayer Study Report [27] | Eccles et al. (2013) [10] |
Design | Double-blind, randomized, placebo controlled, parallel | Double-blind, randomized, placebo controlled, parallel | Double-blind, randomized, placebo controlled, single active ingredient controlled, parallel | Double-blind, randomized, placebo controlled, single active ingredient controlled, parallel |
Treatments | 500 mg ASA plus 30 mg PSE 1000 mg ASA plus 60 mg PSE 1000 mg PAR plus 60 mg PSE Placebo | 500 mg ASA plus 30 mg PSE 1000 mg ASA plus 60 mg PSE 1000 mg PAR plus 60 mg PSE Placebo | 1000 mg ASA plus 60 mg PSE 1000 mg ASA 60 mg PSE Pacebo | 1000 mg ASA plus 60 mg PSE 1000 mg ASA 60 mg PSE Placebo |
Diagnosis | Patients with URTI having symptom nasal congestion | Patients with URTI having symptom sore throat | Patients with URTI having symptoms nasal congestion and sore throat | Patients with URTI having symptoms nasal congestion and sore throat and/or headache |
Number of patients per treatment arm | ASA 500 plus PSE 30: 161 ASA 1000 plus PSE 30: 161 PAR plus PSE: 159 Placebo: 159 | ASA 500 plus PSE 30: 164 ASA 1000 plus PSE 60: 159 PAR plus PSE: 158 Placebo: 159 | ASA plus PSE: 253 ASA: 250 PSE: 251 Placebo: 261 | ASA plus PSE: 235 ASA: 240 PSE: 237 Placebo: 121 |
Endpoints | Nasal decongestion | Pain relief | Pain relief Nasal decongestion | Pain relief Nasal decongestion |
Methodology | Decongestion scales (subjectively) | Pain scales (subjectively) | Pain scales and decongestion scales (subjectively) | Pain scales and decongestion scales (subjectively) and rhinomanometry (objectively) |
Results | ASA 500 plus PSE 30 > Placebo ASA 1000 plus PSE 60 > Placebo PAR 1000 plus PSE 60 > Placebo | ASA 500 plus PSE 30 > Placebo ASA 1000 plus PSE 60 > Placebo PAR 1000 plus PSE 60 > Placebo | Endpoint pain relief: ASA plus PSE = ASA = PSE = Placebo Endpoint decongestion: ASA plus PSE = PSE = ASA = Placebo | Endpoint pain relief: ASA plus PSE = ASA > PSE > Placebo Endpoint decongestion: ASA plus PSE = PSE > ASA > Placebo |