Trial Outcomes & Findings for Comparison of Efficacy and Tolerability of Two Cough Syrups in Cough Due to Cold in Children. (NCT NCT01968434)
NCT ID: NCT01968434
Last Updated: 2018-02-23
Results Overview
Night cough is most bothersome to the child and family. Cough was measured with a validated questionnaire which asks parents to rate 5 aspects of night cough: frequency, severity, bothersomeness, child sleep and parent sleep according to a 7 point Likert scale, from 0 (not at all) to 6 (extremely). Lower scores indicate a better condition. The morning after the first night of treatment (N1) the parents rated the passed night by scoring from 0-6 each of the 5 aspects of night cough. The sum of scores for all 5 aspects gives the combined night cough score. This score, ranging between 0-30, was subtracted from the sum of all aspects, also ranging between 0-30, form the basal night cough score of the night before enrollment (N0). This change is recorded as "change in combined night cough score" and it refers to the change from N0 to N1. Negative values of the change indicate an improvement in the condition of the patient.
COMPLETED
PHASE4
150 participants
1 night from before enrollment (N0) to first night after treatment (N1)
2018-02-23
Participant Flow
Recruiting took place within the Clalit health service community day hospitals. Community day hospitals are places where parents go for usual illnesses and treat most community ailments.
Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21)
Participant milestones
| Measure |
Protective Cough Syrup
syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.
Dosage: 6,5 ml three times a day for the duration of the study (4 nights, 3 days)
protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.
Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21) Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated protective syrup n = 78 received intervention n= 78 Lost to follow up n=3 Discontinued intervention n=0 Analyzed n=75 Excluded from analysis n=0
|
Carbocisteine Cough Syrup
Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)
carbocisteine cough syrup: Mucolytic
Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21) Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated carbocisteine syrup n = 72 received intervention n= 72 Lost to follow up n=6 Discontinued intervention n=0 Analyzed n=66 Excluded from analysis n=0
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
72
|
|
Overall Study
COMPLETED
|
75
|
66
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Protective Cough Syrup
syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.
Dosage: 6,5 ml three times a day for the duration of the study (4 nights, 3 days)
protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.
Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21) Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated protective syrup n = 78 received intervention n= 78 Lost to follow up n=3 Discontinued intervention n=0 Analyzed n=75 Excluded from analysis n=0
|
Carbocisteine Cough Syrup
Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)
carbocisteine cough syrup: Mucolytic
Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21) Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated carbocisteine syrup n = 72 received intervention n= 72 Lost to follow up n=6 Discontinued intervention n=0 Analyzed n=66 Excluded from analysis n=0
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
Baseline Characteristics
Comparison of Efficacy and Tolerability of Two Cough Syrups in Cough Due to Cold in Children.
Baseline characteristics by cohort
| Measure |
Protective Cough Syrup
n=78 Participants
syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum in a syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.
Dosage: 6.5 ml three times a day for the duration of the study (4 nights, 3 days)
protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.
Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated protective syrup n = 78 received intervention n= 78 Lost to follow up n=3 Discontinued intervention n=0 Analyzed n=75 Excluded from analysis n=0
|
Carbocisteine Cough Syrup
n=72 Participants
Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)
carbocisteine cough syrup: Mucolytic
Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated carbocisteine syrup n = 72 received intervention n= 72 Lost to follow up n=6 Discontinued intervention n=0 Analyzed n=66 Excluded from analysis n=0
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.49 months
STANDARD_DEVIATION 12.96 • n=5 Participants
|
43.17 months
STANDARD_DEVIATION 14.57 • n=7 Participants
|
42.8 months
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
78 participants
n=5 Participants
|
72 participants
n=7 Participants
|
150 participants
n=5 Participants
|
|
Participants coughing since ≥ 3 days at time of enrollment
|
47 participants
n=5 Participants
|
46 participants
n=7 Participants
|
93 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 night from before enrollment (N0) to first night after treatment (N1)Population: the population analyzed are the children who completed the protocol and submitted the complete questionnaire for night and day cough. 78 patients were enrolled in the protective syrup Group and 72 in the carbocysteine Group. 3 patients in the protective syrup group and 6 in the carbocysteine group never began the study.
Night cough is most bothersome to the child and family. Cough was measured with a validated questionnaire which asks parents to rate 5 aspects of night cough: frequency, severity, bothersomeness, child sleep and parent sleep according to a 7 point Likert scale, from 0 (not at all) to 6 (extremely). Lower scores indicate a better condition. The morning after the first night of treatment (N1) the parents rated the passed night by scoring from 0-6 each of the 5 aspects of night cough. The sum of scores for all 5 aspects gives the combined night cough score. This score, ranging between 0-30, was subtracted from the sum of all aspects, also ranging between 0-30, form the basal night cough score of the night before enrollment (N0). This change is recorded as "change in combined night cough score" and it refers to the change from N0 to N1. Negative values of the change indicate an improvement in the condition of the patient.
Outcome measures
| Measure |
Protective Cough Syrup
n=75 Participants
syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.
Dosage: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)
protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.
|
Carbocisteine Cough Syrup
n=66 Participants
Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)
carbocisteine cough syrup: Mucolytic
|
|---|---|---|
|
Change in Night Cough Score on First Night of Treatment (From N0 to N1)
|
-5.16 change in combined night cough score
Standard Error 0.85
|
-1.77 change in combined night cough score
Standard Error 0.67
|
SECONDARY outcome
Timeframe: 4 nights (onset of trial Night 1 to Night 4) and 3 daysPopulation: 78 patients were enrolled in the protective syrup Group and 72 in the carbocysteine Group. 3 patients in the protective syrup group and 6 in the carbocysteine group never began the study. 7 patients from the protective syrup group and twelve 12 patients from the carbocysteine group did not answer the questions for the last night.
A validated cough questionnaire measuring 5 aspects of night cough (frequency, severity, bothersomeness, child sleep and parents' sleep) on a 7 point Likert scale was used each morning to rate the passed night. The scale rates each parameter from 0 (not at all) to 6 (extremely). Every night of the trial is rated. The morning after the last night of the study (N4) the parents rated the passed night by scoring from 0-6 each of the 5 aspects of night cough. The summed score for all aspects gives the combined night cough score. This score, ranging between 0-30, was subtracted from the sum of all aspects, also ranging between 0-30, form the basal night cough score of the night before enrollment (N0). This change is recorded as "change in combined night cough score" and it refers to the change from N0 to N4. Negative values of the change indicate an improvement in the condition of the patient.
Outcome measures
| Measure |
Protective Cough Syrup
n=71 Participants
syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.
Dosage: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)
protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.
|
Carbocisteine Cough Syrup
n=60 Participants
Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)
carbocisteine cough syrup: Mucolytic
|
|---|---|---|
|
Change in Night Cough Score at End of Study (From N0 to N4)
|
-13.92 change in combined night cough score
Standard Error 0.92
|
-9.48 change in combined night cough score
Standard Error 1.08
|
SECONDARY outcome
Timeframe: 4 nights (onset of trial Night 1 to Night 4) and 3 daysPopulation: 78 patients were enrolled in the protective syrup Group and 72 in the carbocysteine Group. 3 patients in the protective syrup group and 6 in the carbocysteine group never began the study. 6 patients from the protective syrup group and twelve 11 patients from the carbocysteine group did not answer the questions for the last day.
A validated cough questionnaire measuring 3 aspects of daytime cough (frequency, severity, bothersomeness) on a 7 point Likert scale was used each evening to rate the passed day, as regards these aspects. The scale rates each parameter from 0 (not at all) to 6 (extremely). Every day of the trial is rated. The last evening of the study (D4) the parents rated the passed day by scoring from 0-6 each of the 3 aspects of day cough. The summed score for all aspects gives the combined day cough score. This score, ranging between 0-18, was subtracted from the sum of all aspects, also ranging between 0-18, form the basal day cough score of the day before enrollment (D0). This change is recorded as "change in combined day cough score" and it refers to the change from D0 to D4. Negative values of the change indicate an improvement in the condition of the patient.
Outcome measures
| Measure |
Protective Cough Syrup
n=72 Participants
syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.
Dosage: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)
protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.
|
Carbocisteine Cough Syrup
n=61 Participants
Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)
carbocisteine cough syrup: Mucolytic
|
|---|---|---|
|
Change in Day Cough Score at End of Study (From D0 to D4)
|
-6.17 change in combined day cough score
Standard Error 0.43
|
-4.54 change in combined day cough score
Standard Error 0.6
|
Adverse Events
Protective Cough Syrup
Carbocisteine Cough Syrup
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Protective Cough Syrup
n=75 participants at risk
syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.
Dosage: 6,5 ml three times a day for the duration of the study (4 nights, 3 days)
protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.
|
Carbocisteine Cough Syrup
n=66 participants at risk
Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)
carbocisteine cough syrup: Mucolytic
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
6.7%
5/75 • Number of events 5 • Adverse events were recorded during study period, from first enrollment to last collected data, which was a period of 5 months. Due to the nature of ailment and of treatment it was envisaged that any adverse event would be evident within study period.
Adverse events were systematically collected by the CRF questionnaire.
|
9.1%
6/66 • Number of events 6 • Adverse events were recorded during study period, from first enrollment to last collected data, which was a period of 5 months. Due to the nature of ailment and of treatment it was envisaged that any adverse event would be evident within study period.
Adverse events were systematically collected by the CRF questionnaire.
|
|
Skin and subcutaneous tissue disorders
rash
|
1.3%
1/75 • Number of events 1 • Adverse events were recorded during study period, from first enrollment to last collected data, which was a period of 5 months. Due to the nature of ailment and of treatment it was envisaged that any adverse event would be evident within study period.
Adverse events were systematically collected by the CRF questionnaire.
|
1.5%
1/66 • Number of events 1 • Adverse events were recorded during study period, from first enrollment to last collected data, which was a period of 5 months. Due to the nature of ailment and of treatment it was envisaged that any adverse event would be evident within study period.
Adverse events were systematically collected by the CRF questionnaire.
|
|
Nervous system disorders
drowsiness
|
0.00%
0/75 • Adverse events were recorded during study period, from first enrollment to last collected data, which was a period of 5 months. Due to the nature of ailment and of treatment it was envisaged that any adverse event would be evident within study period.
Adverse events were systematically collected by the CRF questionnaire.
|
3.0%
2/66 • Number of events 2 • Adverse events were recorded during study period, from first enrollment to last collected data, which was a period of 5 months. Due to the nature of ailment and of treatment it was envisaged that any adverse event would be evident within study period.
Adverse events were systematically collected by the CRF questionnaire.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place