Respiratory Tract Infections, Fever
Conditions
Keywords
Upper Respiratory Tract Infections
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.
Interventions
Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Paracetamol
DRUGParacetamol
Paracetamol 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Paracetamol, and 2 Placebo tablets of Acetylsalicylic Acid
DRUGPlacebo
2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Paracetamol, orally, single dose
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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 |
Countries
Russia, Ukraine
Outcome results
None listed