Symptomatic Treatment of Common Cold Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Common Cold

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* 1-2 tablets matching Placebo as needed every 4-6 hours over a maximum of 5 days<br>|
| Experimental: Arm 1<br> | Drug: Aspirin (Acetylsalicylic acid, BAYE4465)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptomatic treatment of Common Cold symptoms