Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold

Inclusion Criteria:

1. Male or female subjects aged between 18 and 75 years inclusive on the date ofconsent

2. No fever or (mild) fever below 38.5° C

3. Total score (sum of all ratings) of 2 or higher based on the rating of the followingsymptoms of common cold (Jackson scale):

4. Sneezing

5. Nasal discharge

6. Nasal obstruction

7. Sore throat

8. Cough

9. Headache

10. Malaise

11. Chilliness according to the following rating scale: 0 = absent, 1 = mild, 2 =moderate, or 3 = severe

12. Presence of cough with thick mucus production

13. Informed consent to participate in the trial provided in written form

Exclusion Criteria:

1. Duration of any of the symptoms of common cold of more than 72 hours at the time ofscreening

2. History of hypersensitivity or intolerance to the active substances or any of theexcipients of the trial medication

3. Known bronchial asthma or chronic obstructive pulmonary disease

4. Known duodenal or gastric ulcer

5. Known hyperthyroidism

6. Known narrow angle glaucoma

7. Known pheochromocytoma

8. Known prostate adenoma with urine retention

9. Known severe liver failure (Child-Pugh > 9)

10. Known severe cardio-vascular diseases

11. Known porphyria

12. Known glucose-6-phosphate dehydrogenase deficiency

13. High fever (body temperature above 38.5°C)

14. Intake of antibiotics, immunosuppressing, immuno-stimulating or immuno-modulatingmedication, within 30 days prior to screening visit

15. Intranasal or systemic use of corticosteroids within 30 days prior to screeningvisit

16. Intake of antihistamines or nasal decongestants within 48 hours prior to screeningvisit

17. Vaccination within 14 days prior to screening visit

18. Immunocompromised state

19. Suspicion for acute bacterial infection

20. Pregnant or breast-feeding female patient

21. Female patient of childbearing potential (not surgically sterilized/ hysterectomizedor postmenopausal for at least 1 year) who is not currently using (documented atscreening visit) and not willing to use medically reliable methods of contraceptionfor the entire trial duration such as barrier method, oral, injectable orimplantable contraceptives, intrauterine contraceptive devices (IUD), sexualabstinence or vasectomized partner

22. Any other condition of the patient (e.g. serious or unstable medical orpsychological condition, acute psychosis) that in the opinion of the investigatormay compromise evaluation of the trial treatment or may jeopardize patient's safety,compliance or adherence to protocol requirements

23. Participation in ANY research study involving another investigational medicinalproduct (IMP) within 30 days prior to screening visit, or simultaneous participationin another clinical study or previous participation in present study

24. Suspected alcohol/ drug dependence or abuse (including heavy smoking: ≥ 20cigarettes daily)

25. Legal incapacity and/or other circumstances rendering the patient unable tounderstand the nature, scope and possible consequences of the trial

26. Subjects who are known or suspected:

• not to comply with the trial directives

• not to be reliable or trustworthy

• to be a dependent person, e.g. a relative, family member, or member/ employeeof the investigator's or sponsor's staff

• subject is in custody or submitted to an institution due to a judicial order.