Common Cold
Conditions
Keywords
Aspirin Complex, Acetylsalicylic Acid, Pseudoephedrine, Common Cold
Brief summary
The purpose of the study is to determine the effectiveness of an acetylsalicylic acid (aspirin) pseudoephedrine combination for the treatment of pain and congestion symptoms compared to the effectiveness of the individual components of the medicine and the placebo (dummy treatment that looks like the real thing).The combination product of acetylsalicylic acid / pseudoephedrine is already marketed in several European countries as Aspirin® Complex.
Interventions
2 Sachets of 500 mg Aspirin Complex.
DRUGPseudoephedrine
2 Sachets of 30 mg Pseudoephedrine
DRUGPlacebo
Matching Placebo
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient in general good health with suspected viral upper respiratory tract infection (common cold)
Exclusion criteria
* \< 18 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of nasal congestion and relief of pain | 4 hours |
Secondary
| Measure | Time frame |
|---|---|
| Sum of subjective nasal congestion intensity differences | 1h, 2h, 3h, 4h and 1, 2, 3 days |
| Total subjective nasal congestion relief | 1h, 2h, 3h,4 h and 1, 2, 3 days |
| Global assessment of nasal congestion | 3 days |
| Area under the curve for nasal airflow conductance from baseline | 1h, 2h, 3h |
| Sum of pain intensity differences | 1h, 2h, 3h, 4h and 1, 2, 3 days |
| Total pain relief | 1, 2, 3 days |
| Adverse Event collection and physical examination | 3 days |
| Global assessment of pain relief | 3 days |
Countries
United Kingdom
Outcome results
None listed