Placebo and Active Controlled Study to Compare the Antipyretic Efficacy of Aspirin® in Patients With Acute Febrile Upper Respiratory Tract Infections Suspected to be of Viral Origin

Study Overview
=================
Brief Summary
-----------------
This study is addressed to patients suffering from an acute febrile upper respiratory tract infection suspected to be of viral origin. The purpose of this study is to determine the antipyretic efficacy (reduction of fever by lowering the body temperature from a raised state) of Aspirin in doses of 500 and 1000 mg (study medication) compared to the one of Paracetamol in doses of 500 and 1000 mg (comparator medication) as well as the one of Placebo (comparator medication without an active substance). Despite of its common use for fever treatment, the scientific data in adults which support the antipyretic efficacy of Aspirin are sparse. Therefore, the purpose of this study is to collect such data.

Official Title
-----------------
A Randomized, Double-blind, Double-dummy, Single-dose, Parallel Group, Multicenter Study to Compare the Antipyretic Efficacy of Acetylsalicy-lic Acid 500 mg and 1,000 mg (2 x 500 mg) and Paracetamol 500 mg and 1,000 mg (2 x 500 mg) With Placebo in Patients With Acute Febrile Upper Respiratory Tract Infections Suspected to be of Viral Origin.

Conditions
-----------------
Respiratory Tract Infections, Fever

Intervention / Treatment
-----------------
* Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
* Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
* Drug: Paracetamol
* Drug: Paracetamol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory male or female patients 18 to 65 years of age Acute uncomplicated febrile URTI suspected to be of viral origin and present not more than 5 days Symptoms of a viral URTI Oral temperature >/= 38.5 °C to </= 40°C Exclusion Criteria: Patients with physical findings consistent with the diagnosis of pneumonia, otitis media, bacterial sinusitis or any other bacterial infection of the respiratory tract requiring antibiotics or other therapeutic intervention by a physician Current antibiotic treatment or pre-treatment with antibiotic agents during the last week History or presence of asthma or hypersensitivity to ASA, salicylates, paracetamol, or other non-steroidal anti-inflammatory drugs; peptic ulceration or gastric bleeding; hemorrhagic diathesis; hepatic and/or renal dysfunction; Gilbert's disease; Quincke's edema Any other acute or chronic disease which in the opinion f the investigator could interfere with the patient's health and well-being during the conduct of the study or which could interfere with the evaluation of data generated from this subject Any conditions possibly interfering with the gastro-intestinal absorption of the study medication Pregnant or lactating women. All women of childbearing age were to undergo a pregnancy test before start of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 2<br> | Drug: Acetylsalicylic acid (Aspirin, BAYE4465)<br>* Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Paracetamol<br>|
| Active Comparator: Arm 3<br> | Drug: Paracetamol<br>* Paracetamol 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Paracetamol, and 2 Placebo tablets of Acetylsalicylic Acid<br>|
| Active Comparator: Arm 4<br> | Drug: Paracetamol<br>* Paracetamol 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid<br>|
| Placebo Comparator: Arm 5<br> | Drug: Placebo<br>* 2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Paracetamol, orally, single dose<br>|
| Experimental: Arm 1<br> | Drug: Acetylsalicylic acid (Aspirin, BAYE4465)<br>* Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Paracetamol<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) of the orally measured change of body temparature from baseline over a period of 0 - 4 hours post dose. |  | Up to 4 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum temperature difference between baseline and the lowest measured temperature |  | Up to 4 hours post dose | 
| Time to reach the maximum temperature difference |  | Up to 4 hours post dose | 
| Intensity of Upper Respiratory Tract Infection symptoms |  | 0, 2, 4, and 6 hours post dose | 
| Safety - assessment of adverse events |  | Up to 7 hours post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Upper Respiratory Tract Infections