Clinical trial NCT01464944: 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
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Tract Infections
Fever
Keywords: Upper Respiratory Tract Infections
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-11-04
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Area under the curve (AUC) of the orally measured change of body temparature from baseline over a period of 0 - 4 hours post dose.
timeFrame: Up to 4 hours post dose
Secondary outcomes:
measure: Maximum temperature difference between baseline and the lowest measured temperature
timeFrame: Up to 4 hours post dose
measure: Time to reach the maximum temperature difference
timeFrame: Up to 4 hours post dose
measure: Intensity of Upper Respiratory Tract Infection symptoms
timeFrame: 0, 2, 4, and 6 hours post dose
measure: Safety - assessment of adverse events
timeFrame: Up to 7 hours post dose
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Lugansk
country: Ukraine
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: