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

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.

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Fever
• Intervention / Treatment: Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Drug: Paracetamol; Drug: Paracetamol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 392
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 127299
  • Moscow, Russian Federation, 127015
  • Moscow, Russian Federation, 105064
  • Moscow, Russian Federation, 107996
  • Moscow, Russian Federation, 109386
  • Moscow, Russian Federation, 125183
• Ukraine
  • Kiev, Ukraine, 03049
  • Kiev, Ukraine, 02232
  • Lugansk, Ukraine, 91011

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1	Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Paracetamol; Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Paracetamol
EXPERIMENTAL: Arm 2	Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Paracetamol; Drug: Acetylsalicylic acid (Aspirin, BAYE4465); Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Paracetamol
PLACEBO_COMPARATOR: Arm 5	Drug: Placebo; 2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Paracetamol, orally, single dose
ACTIVE_COMPARATOR: Arm 3	Drug: Paracetamol; Paracetamol 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Paracetamol, and 2 Placebo tablets of Acetylsalicylic Acid; Drug: Paracetamol; Paracetamol 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid
ACTIVE_COMPARATOR: Arm 4	Drug: Paracetamol; Paracetamol 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Paracetamol, and 2 Placebo tablets of Acetylsalicylic Acid; Drug: Paracetamol; Paracetamol 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Study Completion (ACTUAL): April 1, 2004

Study Registration Dates

• First Submitted: May 17, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (ESTIMATE): November 4, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 8, 2011
• Last Update Submitted That Met QC Criteria: November 7, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Upper Respiratory Tract Infections
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin; Acetaminophen
• Other Study ID Numbers: 11202 (Registry Identifier: DAIDS ES Registry Number)