Common Cold
Conditions
Keywords
Symptomatic treatment of Common Cold symptoms
Brief summary
A two-arm, multicenter, randomized, double-blind, single dose placebo-controlled parallel groups study evaluating efficacy and tolerability of 800 mg Acetylsalicylic Acid (Aspirina C) in adult patients with a common cold during a two hour in patient phase; and a follow-up period of five days of home treatment as required.
Interventions
1-2 tablets Acetylsalicylic Acid 400 mg (in combination with Ascorbic Acid 240 mg) as needed every 4-6 hours over a maximum of 5 days
DRUGPlacebo
1-2 tablets matching Placebo as needed every 4-6 hours over a maximum of 5 days
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 65 years * Onset of cold symptoms within 48 hours before screening * Objective symptoms of common cold * Subjective symptoms of common cold
Exclusion criteria
* Pregnancy or lactation period * Active peptic ulcer * Hemorrhagic diathesis * History of chronic or recurrent ulcer disease or history of gastro-intestinal bleeding * Hypersensitivity to acetylsalicylic acid, to paracetamol, to any other component of the study medication, to anti-inflammatory or antirheumatic drugs, to other allergens
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baseline | 2 hours following intake of the first study medication dose |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Global Cold Severity (WURSS domain 1) | At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period) |
| Changes in Cold Symptoms (WURSS domain 2) | At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period) |
| Changes in Common Cold Profile (sum of WURSS domains 1 182 3) | At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period) |
| Changes in Global Cold Severity (WURSS domain 4) | At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period) |
| Adverse Event Collection | Until end of study |
| Changes in Cold-specific Functional Impairments (WURSS domain 3) | At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period) |
Countries
Italy
Outcome results
None listed