Prospective, randomized, multinational, multicenter, double-blind trial in 2 parallel groups of patients
This study is a prospective, randomized, multinational, multicenter, double-blind trial in 2 parallel groups of patients. Patients will undergo screening examinations at Visit 1. Patients who meet all of the inclusion and none of the exclusion criteria will be randomized to double-blind treatment with one of the following: * Group A: Acetylcysteine/Paracetamol/Phenylephrine: one sachet three times per day OR * Group B: Paracetamol/Phenylephrine 500 mg/10 mg granules for oral solution: one sachet three times per day. A control visit (Visit 2) is planned on Day 3 of treatment. After the end of the double-blind treatment phase, the patients will undergo an end-of-treatment (EOT) examination at Visit 3 on Day 6.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
200 mg/500 mg/10 mg granules for oral solution: one sachet three times per day
500 mg/10 mg granules for oral solution: one sachet three times per day
500 mg/10 mg granules for oral solution
Change from baseline in the daily Score of 8 symptoms related to mucus production (SUM8)
Score of 8 symptoms related to mucus production (SUM8) will be assessed by the patient in a patient's diary at screening (this will constitute the baseline value) and daily on each day of treatment until and including Day 5. For assessing SUM8 the patients will have to answer questions about their cough and phlegm status. The SUM8 consisted of the sum of the answers to the eight core questions. For calculating the SUM8 the lowest rating corresponds to 0 and highest rating corresponds to 4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.
Time frame: Baseline, Day 5
Number of adverse events and serious adverse events
Assessment of safety and tolerability of the investigational medicinal product against the comparator product for the treatment of common cold
Time frame: Until Day 6, or earlier in case of premature termination
Time to onset of action
Time to onset of action defined as first day of treatment with investigational product on which SUM8 shows statistically significant difference from the comparator product will be reported
Time frame: Day 1 to Day 5
Score of 8 symptoms related to mucus production (SUM8) development over the course of the study
Score of 8 symptoms related to mucus production (SUM8) will be assessed by the patient in a patient's diary at screening (this will constitute the baseline value) and daily on each day of treatment until and including Day 5. For assessing SUM8 the patients will have to answer questions about their cough and phlegm status. The SUM8 consisted of the sum of the answers to the eight core questions. For calculating the SUM8 the lowest rating corresponds to 0 and highest rating corresponds to 4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.
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Time frame: Baseline, Day 1 to Day 5
Assessment of separate items of Score of 8 symptoms related to mucus production (SUM8)
Score of 8 symptoms related to mucus production (SUM8) will be assessed by the patient in a patient's diary at screening (this will constitute the baseline value) and daily on each day of treatment until and including Day 5. For assessing SUM8 the patients will have to answer questions about their cough and phlegm status. The SUM8 consisted of the sum of the answers to the eight core questions. For calculating the SUM8 the lowest rating corresponds to 0 and highest rating corresponds to 4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.
Time frame: Baseline, Day 1 to Day 5
Sum of changes from baseline in the daily Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire is an evaluative illness-specific outcomes instrument designed to assess the severity of cold symptoms and the impact of the common cold (range 0-140), with higher scores indicating more symptoms and functional impairment.
Time frame: Baseline, Day 1 to Day 5
Assessment of separate items of Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire is an evaluative illness-specific outcomes instrument designed to assess the severity of cold symptoms and the impact of the common cold (range 0-140), with higher scores indicating more symptoms and functional impairment.
Time frame: Baseline, Day 1 to Day 5
Percentage of responders and non-responders to treatment
Percentage of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator will be reported.
Time frame: On Day 3, and after the end of treatment on Day 6