Clinical trial NCT05070650: Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold
Official title: Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold: a Prospective, Randomized, Double-blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Common Cold
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2021-10-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomized, multinational, multicenter, double-blind trial in 2 parallel groups of patients

Detailed description: 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.

Eligibility criteria: 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):

   1. Sneezing
   2. Nasal discharge
   3. Nasal obstruction
   4. Sore throat
   5. Cough
   6. Headache
   7. Malaise
   8. 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

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.

Primary outcomes:
measure: Change from baseline in the daily Score of 8 symptoms related to mucus production (SUM8)
timeFrame: Baseline, Day 5
Secondary outcomes:
measure: Number of adverse events and serious adverse events
timeFrame: Until Day 6, or earlier in case of premature termination
measure: Time to onset of action
timeFrame: Day 1 to Day 5
measure: Score of 8 symptoms related to mucus production (SUM8) development over the course of the study
timeFrame: Baseline, Day 1 to Day 5
measure: Assessment of separate items of Score of 8 symptoms related to mucus production (SUM8)
timeFrame: Baseline, Day 1 to Day 5
measure: Sum of changes from baseline in the daily Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
timeFrame: Baseline, Day 1 to Day 5
measure: Assessment of separate items of Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
timeFrame: Baseline, Day 1 to Day 5
measure: Percentage of responders and non-responders to treatment
timeFrame: On Day 3, and after the end of treatment on Day 6
Other outcomes:
Locations:
Study officials:
References: