Comparison of Efficacy and Tolerability of Two Cough Syrups in Cough Due to Cold in Children.

NCT ID: NCT01968434

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-04-30

Brief Summary

The purpose of this study is to determine if there is comparable efficacy between carbocisteine and a protective cough syrup from natural ingredients in children's cough due to upper respiratory tract infections (URTI) such as the common cold. The hypothesis is that protecting the throat is very useful in decreasing cough severity, both day and night, without needing to subdue such an important reflex as cough, and without only acting on mucous fluidification, especially in children where sedation and excessive fluidification is dangerous. The research hypothesis is that the protective (Grintuss) Syrup relieves cough (frequency, intensity, degree of disturbance due to nocturnal cough, and improves the quality of sleep of the child) as much as or more than the carbocysteine syrup usually used to treat children (Syr Mucolit).

Detailed Description

Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex. Mucolytic agents have been shown to be helpful but side effects have been reported and use has been prohibited under 2 years of age. Therefore, a completely safe and effective cough remedy has not been officially reported yet in a randomised trial. Looking into other mechanisms for cough management such as protection of irritated pharynx mucosa from post nasal drip or other irritating substances is theoretically sound and shows practical interesting results.

A parallel comparison of efficacy and tolerability between such protective mechanism (acting through a barrier and radical scavenging action) due to natural substances (honey, plantago lanceolata, grindelia robusta and helichrysum italicum) and a mucolytic substance has not been done so far, in young children, especially in a time frame of 4 days. The intent of this study is to use the protective syrup versus carbocysteine in children with moderate to severe night and daily cough, measured with a validated parent questionnaire. The invasiveness of cough is followed immediately after one night administration of the study products and daily for four days.

A similar effectiveness of the protective cough syrup as compared to carbocisteine is considered very interesting due to the mechanism of the remedy.

Conditions

Cough; Upper Respiratory Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)

Group Type: EXPERIMENTAL

protective cough syrup

Intervention Type: DEVICE

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

Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)

Group Type: ACTIVE_COMPARATOR

carbocisteine cough syrup

Intervention Type: DRUG

Mucolytic

Interventions

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.

Intervention Type: DEVICE

carbocisteine cough syrup

Mucolytic

Intervention Type: DRUG

Other Intervention Names

Grintuss; Mucolit; Lisomucil

Eligibility Criteria

Inclusion Criteria

• cough attributed to URTI such as the common cold
• 2-5 years of age
• moderate to severe day cough according to questionnaire (score at least 3 on all 3 questions relating to day cough) considering the day prior to enrollment.
• moderate to severe night cough score according to questionnaire (score at least 3 of 2 of the three questions relating to the evaluation of nocturnal cough (frequency of nocturnal cough, impact of the sleep of the child and impact on the sleep of the parent)
• signature of informed consent

Exclusion Criteria

• Children with the diagnosis of diseases of the lower respiratory tract: inflammation of the larynx, trachea, bronchi, pneumonia, asthma, sinusitis, allergic rhinitis, as well as heart disease.
• Children who received cough medicines or drugs containing antihistamines the day prior to study entry.
• Known hypersensitivity to honey or any other component of the experimental product such as Grindelia, Helichrysum, essential oils natural flavourings of Lemon, Sweet Orange, Myrtle; Lemon natural flavouring
• Children who received any steroid preparation (spray nozzle , or syrup , or other similar the day before study entry )
• Known sensitivity to carbocysteine specifically to the comparator Mucolit
• gastric ulcer

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aboca Spa Societa' Agricola

INDUSTRY

Sponsor Role: collaborator

Clalit Health Services

OTHER

Sponsor Role: lead

Responsible Party

Avner Herman Cohen

MD. Head Dep. Pediatric Ambulatory Clinic -Petah-Tikva, Israel

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Herman Avner Cohen, Professor

Role: PRINCIPAL_INVESTIGATOR

Clalit Health Services

Locations

Pediatric Ambulatory Clinic Bat-Yam

Bat Yam, , Israel

Pediatric Ambulatory Clinic Kfar-Saba

Kfar Saba, , Israel

Pediatric Community Ambulatory Clinic - Petach-Tikva

Petah Tikva, , Israel

Pediatric Ambulatory Clinic Ramat Aviv Gimel

Tel Aviv, , Israel

Countries

Israel

References

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Reference Type: BACKGROUND

PMID: 16841784 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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PMID: 1687577 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Kraft K. Efficacy of fluid in Plantago lanceolata extract (PLFE) in acute respiratory disease. Phytomedicine, Supplement 1, 1996

Reference Type: BACKGROUND

Wegener T, Kraft K. [Plantain (Plantago lanceolata L.): anti-inflammatory action in upper respiratory tract infections]. Wien Med Wochenschr. 1999;149(8-10):211-6. German.

Reference Type: BACKGROUND

PMID: 10483683 (View on PubMed)

Other Identifiers

COM-13-00

Identifier Type: -

Identifier Source: org_study_id