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

Phase 4

Completed

• Conditions: Respiratory Tract Infections; Fever
• Interventions: Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Drug: Placebo; Drug: Paracetamol

• Registration Number: NCT01464944
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study Completion: 2004-04
• Study First Submitted: 2011-05-17
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-04
• Last Update Submitted: 2011-11-07
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Acetylsalicylic acid (Aspirin, BAYE4465)	-
Arm 5	Placebo	-
Arm 1	Acetylsalicylic acid (Aspirin, BAYE4465)	-
Arm 3	Paracetamol	-
Arm 4	Paracetamol	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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