A pivotal, placebo controlled, phaseIII study to compare efficacy and tollerability of a fixed combination, containing 500 mg ASA and 30 mg Pseudoephedrine, in comparison to its single components in patients with sore throat and nasal congestion.

INTERVENTION: Trade Name: Aspirin Complex Pharmaceutical Form: Granules INN or Proposed INN: acetylsalicyclic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ INN or Proposed INN: pseudoephedrine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30‐ CONDITION: Cold related pain/fever e.g. sore throat, headache, ear eache, sinus pressure and nasal congestion. ; MedDRA version: 6.1 Level: PT Classification code 10028735 PRIMARY OUTCOME: Main Objective: verificare la superiorita' della combinazione fissa di ASA 500 mg e PE 30 mg in confronto al solo ASA 500 mg(granuli, 2 bustine) nella congestione nasale nonche la superiorita' della stessa combinazione alla stessa dose in confronto alla sola PE 30 mg (granuli, 2 bustine) nel dolore di gola. ; ; Primary end point(s): 1) congestione nasale: area sotto la curva calcolata sui punteggi corretti per i valori basali di congestione nasale(NCS) nelle due ore iniziali dopo la somministrazione (AUC‐NCS 2ore) 2) dolore di gola: SPID 2 ore, inteso come la somma delle differenze di intensita' del dolore nelle 2 ore iniziali dell'osservazione ; ; Secondary Objective: 1)Safety e tollerabilita' 2) differenze nell'intensita' di dolore verso il basale a vari tempi fino a tre giorni dopo la prima dose 3)Scomparsa del dolore totale verso il basale a vari tempi fino a tre giorni dopo la prima dose ; INCLUSION CRITERIA: • Male and female patients between 18‐65 years of age • Onset of cold symptoms within the previous 96 hours (4 days) • Current complaint of at least moderate sore throat baseline, confirmed by a score = 6 on the sore throat pain scale (numerical 0 ‐ 10 scale) • Current complaint of at least moderate nasal congestion at baseline, confirmed by a score = 6 on the nasal congestion scale (numerical 0 – 10 scale) • History of other symptoms associated with upper respiratory tract infection (URTI) in the past 4 days • Other findings of upper respiratory tract infection, confirmed on the physical examination • Agree to comply with the study requirements • Written informed consent prior to enrollment in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this