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