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

Bayer

Status and phase: Completed; Phase 4

Conditions: Fever; Respiratory Tract Infections

Treatments: Drug: Paracetamol; Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01464944

11202 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 392 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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392 participants in 5 patient groups, including a placebo group

Arm 2

Experimental group

Treatment:

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Arm 3

Active Comparator group

Treatment:

Drug: Paracetamol

Drug: Paracetamol

Arm 4

Active Comparator group

Treatment:

Drug: Paracetamol

Drug: Paracetamol

Arm 5

Placebo Comparator group

Treatment:

Drug: Placebo

Arm 1

Experimental group

Treatment:

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)