Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold
Primary Purpose
Common Cold
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Acetylcysteine
Paracetamol
Phenylephrine
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects aged between 18 and 75 years inclusive on the date of consent
- No fever or (mild) fever below 38.5° C
Total score (sum of all ratings) of 2 or higher based on the rating of the following symptoms of common cold (Jackson scale):
- Sneezing
- Nasal discharge
- Nasal obstruction
- Sore throat
- Cough
- Headache
- Malaise
- Chilliness according to the following rating scale: 0 = absent, 1 = mild, 2 = moderate, or 3 = severe
- Presence of cough with thick mucus production
- Informed consent to participate in the trial provided in written form
Exclusion Criteria:
- Duration of any of the symptoms of common cold of more than 72 hours at the time of screening
- History of hypersensitivity or intolerance to the active substances or any of the excipients of the trial medication
- Known bronchial asthma or chronic obstructive pulmonary disease
- Known duodenal or gastric ulcer
- Known hyperthyroidism
- Known narrow angle glaucoma
- Known pheochromocytoma
- Known prostate adenoma with urine retention
- Known severe liver failure (Child-Pugh > 9)
- Known severe cardio-vascular diseases
- Known porphyria
- Known glucose-6-phosphate dehydrogenase deficiency
- High fever (body temperature above 38.5°C)
- Intake of antibiotics, immunosuppressing, immuno-stimulating or immuno-modulating medication, within 30 days prior to screening visit
- Intranasal or systemic use of corticosteroids within 30 days prior to screening visit
- Intake of antihistamines or nasal decongestants within 48 hours prior to screening visit
- Vaccination within 14 days prior to screening visit
- Immunocompromised state
- Suspicion for acute bacterial infection
- Pregnant or breast-feeding female patient
- 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
- 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
- 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
- Suspected alcohol/ drug dependence or abuse (including heavy smoking: ≥ 20 cigarettes daily)
- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Acetylcysteine/Paracetamol/Phenylephrine 200 mg/500 mg/10 mg granules for oral solution
Paracetamol/Phenylephrine 500 mg/10 mg granules for oral solution
Arm Description
Acetylcysteine/Paracetamol/Phenylephrine 200 mg/500 mg/10 mg granules for oral solution: one sachet three times per day
Paracetamol/Phenylephrine 500 mg/10 mg granules for oral solution: one sachet three times per day
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 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
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05070650
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 20, 2024 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1002 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acetylcysteine/Paracetamol/Phenylephrine 200 mg/500 mg/10 mg granules for oral solution
Arm Type
Experimental
Arm Description
Acetylcysteine/Paracetamol/Phenylephrine 200 mg/500 mg/10 mg granules for oral solution: one sachet three times per day
Arm Title
Paracetamol/Phenylephrine 500 mg/10 mg granules for oral solution
Arm Type
Active Comparator
Arm Description
Paracetamol/Phenylephrine 500 mg/10 mg granules for oral solution: one sachet three times per day
Intervention Type
Drug
Intervention Name(s)
Acetylcysteine
Intervention Description
200 mg/500 mg/10 mg granules for oral solution: one sachet three times per day
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
500 mg/10 mg granules for oral solution: one sachet three times per day
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Intervention Description
500 mg/10 mg granules for oral solution
Primary Outcome Measure Information:
Title
Change from baseline in the daily Score of 8 symptoms related to mucus production (SUM8)
Description
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
Secondary Outcome Measure Information:
Title
Number of adverse events and serious adverse events
Description
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
Title
Time to onset of action
Description
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
Title
Score of 8 symptoms related to mucus production (SUM8) development over the course of the study
Description
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
Title
Assessment of separate items of Score of 8 symptoms related to mucus production (SUM8)
Description
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
Title
Sum of changes from baseline in the daily Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
Description
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
Title
Assessment of separate items of Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
Description
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
Title
Percentage of responders and non-responders to treatment
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects aged between 18 and 75 years inclusive on the date of consent
No fever or (mild) fever below 38.5° C
Total score (sum of all ratings) of 2 or higher based on the rating of the following symptoms of common cold (Jackson scale):
Sneezing
Nasal discharge
Nasal obstruction
Sore throat
Cough
Headache
Malaise
Chilliness according to the following rating scale: 0 = absent, 1 = mild, 2 = moderate, or 3 = severe
Presence of cough with thick mucus production
Informed consent to participate in the trial provided in written form
Exclusion Criteria:
Duration of any of the symptoms of common cold of more than 72 hours at the time of screening
History of hypersensitivity or intolerance to the active substances or any of the excipients of the trial medication
Known bronchial asthma or chronic obstructive pulmonary disease
Known duodenal or gastric ulcer
Known hyperthyroidism
Known narrow angle glaucoma
Known pheochromocytoma
Known prostate adenoma with urine retention
Known severe liver failure (Child-Pugh > 9)
Known severe cardio-vascular diseases
Known porphyria
Known glucose-6-phosphate dehydrogenase deficiency
High fever (body temperature above 38.5°C)
Intake of antibiotics, immunosuppressing, immuno-stimulating or immuno-modulating medication, within 30 days prior to screening visit
Intranasal or systemic use of corticosteroids within 30 days prior to screening visit
Intake of antihistamines or nasal decongestants within 48 hours prior to screening visit
Vaccination within 14 days prior to screening visit
Immunocompromised state
Suspicion for acute bacterial infection
Pregnant or breast-feeding female patient
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
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
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
Suspected alcohol/ drug dependence or abuse (including heavy smoking: ≥ 20 cigarettes daily)
Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandoz
Phone
+49 8024 908 0
Email
sandoz.disclosure@sandoz.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Learn more about this trial
Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold
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