Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold

Study Overview
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Brief Summary
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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.

Official Title
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A Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Acetylsalicylic Acid Combined With Pseudoephedrine, Compared With Acetylsalicylic Acid Alone, and Pseudoephedrine Alone, on Symptoms of Pain.

Conditions
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Common Cold

Intervention / Treatment
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* Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
* Drug: Pseudoephedrine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient in general good health with suspected viral upper respiratory tract infection (common cold) Exclusion Criteria: < 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)<br>* 2 Sachets of 500 mg Aspirin Complex.<br>Drug: Pseudoephedrine<br>* 2 Sachets of 30 mg Pseudoephedrine<br>|
| Active Comparator: Arm 2<br> | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)<br>* 2 Sachets of 500 mg Aspirin Complex.<br>|
| Active Comparator: Arm 3<br> | Drug: Pseudoephedrine<br>* 2 Sachets of 30 mg Pseudoephedrine<br>|
| Placebo Comparator: Arm 4<br> | Drug: Placebo<br>* Matching Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of nasal congestion and relief of pain |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve for nasal airflow conductance from baseline |  | 1h, 2h, 3h | 
| 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 | 
| Global assessment of pain relief |  | 3 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aspirin Complex, Acetylsalicylic Acid, Pseudoephedrine, Common Cold