Efficacy and safety of the combination of acetylcysteine, paracetamol and phenylephrine for the treatment of common cold

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1002

Inclusion Criteria

[1] Male or female subjects aged between 18 and 75 years inclusive on the date of consent
[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 following symptoms of common cold (Jackson scale):
a. Sneezing
b. Nasal discharge
c. Nasal obstruction
d. Sore throat
e. Cough
f. Headache
g. Malaise
h. Chilliness
according to the following rating scale: 0 = absent, 1 = mild, 2 = moderate, or 3 = severe
[4] Presence of cough with thick mucus production
[5] Informed consent to participate in the trial provided in written form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

[1] Duration of any of the symptoms of common cold of more than 72 hours at the time of screening
[2] History of hypersensitivity or intolerance to the active substances or any of the excipients 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-modulating medication, within 30 days prior to screening visit
[15] Intranasal or systemic use of corticosteroids within 30 days prior to screening visit
[16] Intake of antihistamines or nasal decongestants within 48 hours prior to screening visit
[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/ hysterectomized or postmenopausal for at least 1 year) who is not currently using (documented at screening visit) and not willing to use medically reliable methods of contraception for the entire trial duration such as barrier method, oral, injectable or implantable contraceptives, intrauterine contraceptive devices (IUD), sexual abstinence or vasectomized partner
[22] Any other condition of the patient (e.g. serious or unstable medical or psychological condition, acute psychosis) that in the opinion of the investigator may 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 medicinal product (IMP) within 30 days prior to screening visit, or simultaneous participation in another clinical study or previous participation in present study
[24] Suspected alcohol/ drug dependence or abuse (including heavy smoking: = 20 cigarettes daily)
[25] Legal incapacity and/or other circumstances rendering the patient unable to understand 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/ employee of the investigator’s or sponsor’s staff
- subject is in custody or submitted to an institution due to a judicial order.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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