Open-Label Taste-Testing Study to Evaluate the Acceptability of Both Strawberry-Flavored and Orange-Flavored Amylmetacresol/2,4-Dichlorobenzyl Alcohol Throat Lozenges in Healthy Children
Identifieur interne : 000662 ( Pmc/Curation ); précédent : 000661; suivant : 000663Open-Label Taste-Testing Study to Evaluate the Acceptability of Both Strawberry-Flavored and Orange-Flavored Amylmetacresol/2,4-Dichlorobenzyl Alcohol Throat Lozenges in Healthy Children
Auteurs : Alex Thompson ; Sandie Reader [Royaume-Uni] ; Emma Field ; Adrian ShephardSource :
- Drugs in R&D [ 1174-5886 ] ; 2013.
Abstract
Acute sore throat (pharyngitis) is one of the most common illnesses for which children are seen by primary care physicians. Most cases are caused by viruses and are benign and self-limiting. Clinically proven, over-the-counter throat lozenges provide rapid and effective relief of acute sore throat symptoms, and are increasingly important in self-management of this condition.
The purpose of this study (International Standard Randomized Controlled Trial Number: ISRCTN34958871) was to evaluate the acceptability of two licensed, commercially available sore throat lozenges containing amylmetacresol and 2,4-dichlorobenzyl (AMC/DCBA)—one strawberry flavored and the other orange flavored—in healthy children.
This was an open-label, single-dose, crossover, taste-testing study in children recruited via a clinical database and advertisements over a 3.5-week period.
Potentially eligible participants were invited to attend the taste-testing session at a clinic.
At the screening session, which took place either before or on the day of taste testing, details of relevant medical history, medication, and demographics were recorded. Of the 108 screened subjects, 102 were recruited. These were healthy male and female children aged 6–12 years.
Each child cleansed their palate with water and water biscuits before tasting a strawberry-flavored lozenge (Strepsils® strawberry sugar free, Reckitt Benckiser Healthcare Limited, Nottingham, UK; PL 00063/0395), which was sucked for 1 minute and then expelled. The orange-flavored lozenge (Strepsils® orange with vitamin C, Reckitt Benckiser Healthcare Limited, Nottingham, UK; PL 016242152) was tasted at least 15 minutes later following further cleansing of the palate. The spontaneous reaction of the child on tasting each lozenge was observed and recorded. Subjects were asked to indicate their liking for each lozenge, using a 7-point hedonic facial scale, and were required to answer a series of questions relating to what they liked and disliked about the taste and the feel of the lozenge in the mouth and throat. The primary endpoint was the proportion of subjects with a hedonic facial score of >4. Secondary endpoints included the spontaneous reaction of the child on tasting the lozenge and responses to questions related to taste.
The taste of the lozenge was scored >4 (i.e. ‘good’, ‘really good’, or ‘super good’) by 85.3 % of subjects for the strawberry flavor and 49.0 % for the orange flavor (
Strawberry-flavored AMC/DCBA lozenges were liked by, and acceptable to, the majority of the children. AMC/DCBA orange-flavored lozenges were also liked by, and acceptable to, approximately half the children. Overall, both strawberry and orange would be suitable flavors for lozenges intended for children when they suffer from sore throat.
Url:
DOI: 10.1007/s40268-013-0012-x
PubMed: 23588685
PubMed Central: 3689904
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Alex Thompson<affiliation><nlm:aff id="Aff1">Aspect Clinical, 4a Bye Street, Ledbury, Herefordshire HR8 2AA UK</nlm:aff>
<wicri:noCountry code="subfield">Herefordshire HR8 2AA UK</wicri:noCountry>
</affiliation>
<affiliation><nlm:aff id="Aff3">Reckitt Benckiser Healthcare Ltd, Dansom Lane, Hull, Yorkshire UK</nlm:aff>
<wicri:noCountry code="subfield">Yorkshire UK</wicri:noCountry>
</affiliation>
<affiliation><nlm:aff id="Aff4">Reckitt Benckiser Healthcare Ltd, 103-105 Bath Road, Slough, Berkshire UK</nlm:aff>
<wicri:noCountry code="subfield">Berkshire UK</wicri:noCountry>
</affiliation>
Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Open-Label Taste-Testing Study to Evaluate the Acceptability of Both Strawberry-Flavored and Orange-Flavored Amylmetacresol/2,4-Dichlorobenzyl Alcohol Throat Lozenges in Healthy Children</title>
<author><name sortKey="Thompson, Alex" sort="Thompson, Alex" uniqKey="Thompson A" first="Alex" last="Thompson">Alex Thompson</name>
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<author><name sortKey="Reader, Sandie" sort="Reader, Sandie" uniqKey="Reader S" first="Sandie" last="Reader">Sandie Reader</name>
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<author><name sortKey="Shephard, Adrian" sort="Shephard, Adrian" uniqKey="Shephard A" first="Adrian" last="Shephard">Adrian Shephard</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Open-Label Taste-Testing Study to Evaluate the Acceptability of Both Strawberry-Flavored and Orange-Flavored Amylmetacresol/2,4-Dichlorobenzyl Alcohol Throat Lozenges in Healthy Children</title>
<author><name sortKey="Thompson, Alex" sort="Thompson, Alex" uniqKey="Thompson A" first="Alex" last="Thompson">Alex Thompson</name>
<affiliation><nlm:aff id="Aff1">Aspect Clinical, 4a Bye Street, Ledbury, Herefordshire HR8 2AA UK</nlm:aff>
<wicri:noCountry code="subfield">Herefordshire HR8 2AA UK</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Reader, Sandie" sort="Reader, Sandie" uniqKey="Reader S" first="Sandie" last="Reader">Sandie Reader</name>
<affiliation wicri:level="1"><nlm:aff id="Aff2">Clearcut Clinical Consulting Ltd, 37 Wollaton Vale, Nottingham, UK</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Clearcut Clinical Consulting Ltd, 37 Wollaton Vale, Nottingham</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Field, Emma" sort="Field, Emma" uniqKey="Field E" first="Emma" last="Field">Emma Field</name>
<affiliation><nlm:aff id="Aff3">Reckitt Benckiser Healthcare Ltd, Dansom Lane, Hull, Yorkshire UK</nlm:aff>
<wicri:noCountry code="subfield">Yorkshire UK</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Shephard, Adrian" sort="Shephard, Adrian" uniqKey="Shephard A" first="Adrian" last="Shephard">Adrian Shephard</name>
<affiliation><nlm:aff id="Aff4">Reckitt Benckiser Healthcare Ltd, 103-105 Bath Road, Slough, Berkshire UK</nlm:aff>
<wicri:noCountry code="subfield">Berkshire UK</wicri:noCountry>
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<series><title level="j">Drugs in R&D</title>
<idno type="ISSN">1174-5886</idno>
<idno type="eISSN">1179-6901</idno>
<imprint><date when="2013">2013</date>
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>Acute sore throat (pharyngitis) is one of the most common illnesses for which children are seen by primary care physicians. Most cases are caused by viruses and are benign and self-limiting. Clinically proven, over-the-counter throat lozenges provide rapid and effective relief of acute sore throat symptoms, and are increasingly important in self-management of this condition.</p>
</sec>
<sec><title>Objective</title>
<p>The purpose of this study (International Standard Randomized Controlled Trial Number: ISRCTN34958871) was to evaluate the acceptability of two licensed, commercially available sore throat lozenges containing amylmetacresol and 2,4-dichlorobenzyl (AMC/DCBA)—one strawberry flavored and the other orange flavored—in healthy children.</p>
</sec>
<sec><title>Study design</title>
<p>This was an open-label, single-dose, crossover, taste-testing study in children recruited via a clinical database and advertisements over a 3.5-week period.</p>
</sec>
<sec><title>Setting</title>
<p>Potentially eligible participants were invited to attend the taste-testing session at a clinic.</p>
</sec>
<sec><title>Participants</title>
<p>At the screening session, which took place either before or on the day of taste testing, details of relevant medical history, medication, and demographics were recorded. Of the 108 screened subjects, 102 were recruited. These were healthy male and female children aged 6–12 years.</p>
</sec>
<sec><title>Intervention</title>
<p>Each child cleansed their palate with water and water biscuits before tasting a strawberry-flavored lozenge (Strepsils<sup>®</sup>
strawberry sugar free, Reckitt Benckiser Healthcare Limited, Nottingham, UK; PL 00063/0395), which was sucked for 1 minute and then expelled. The orange-flavored lozenge (Strepsils<sup>®</sup>
orange with vitamin C, Reckitt Benckiser Healthcare Limited, Nottingham, UK; PL 016242152) was tasted at least 15 minutes later following further cleansing of the palate. The spontaneous reaction of the child on tasting each lozenge was observed and recorded. Subjects were asked to indicate their liking for each lozenge, using a 7-point hedonic facial scale, and were required to answer a series of questions relating to what they liked and disliked about the taste and the feel of the lozenge in the mouth and throat. The primary endpoint was the proportion of subjects with a hedonic facial score of >4. Secondary endpoints included the spontaneous reaction of the child on tasting the lozenge and responses to questions related to taste.</p>
</sec>
<sec><title>Results</title>
<p>The taste of the lozenge was scored >4 (i.e. ‘good’, ‘really good’, or ‘super good’) by 85.3 % of subjects for the strawberry flavor and 49.0 % for the orange flavor (<italic>p</italic>
< 0.0001). The mean (standard deviation) score was 5.72 (1) for the strawberry-flavored lozenge and 4.35 (2) for the orange-flavored lozenge. The proportion of subjects willing to take the lozenge again was 94 % for the strawberry flavor and 56 % for the orange flavor.</p>
</sec>
<sec><title>Conclusions</title>
<p>Strawberry-flavored AMC/DCBA lozenges were liked by, and acceptable to, the majority of the children. AMC/DCBA orange-flavored lozenges were also liked by, and acceptable to, approximately half the children. Overall, both strawberry and orange would be suitable flavors for lozenges intended for children when they suffer from sore throat.</p>
</sec>
</div>
</front>
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<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Drugs R D</journal-id>
<journal-id journal-id-type="iso-abbrev">Drugs R D</journal-id>
<journal-title-group><journal-title>Drugs in R&D</journal-title>
</journal-title-group>
<issn pub-type="ppub">1174-5886</issn>
<issn pub-type="epub">1179-6901</issn>
<publisher><publisher-name>Springer International Publishing AG</publisher-name>
<publisher-loc>Cham</publisher-loc>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">23588685</article-id>
<article-id pub-id-type="pmc">3689904</article-id>
<article-id pub-id-type="publisher-id">12</article-id>
<article-id pub-id-type="doi">10.1007/s40268-013-0012-x</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Original Research Article</subject>
</subj-group>
</article-categories>
<title-group><article-title>Open-Label Taste-Testing Study to Evaluate the Acceptability of Both Strawberry-Flavored and Orange-Flavored Amylmetacresol/2,4-Dichlorobenzyl Alcohol Throat Lozenges in Healthy Children</article-title>
</title-group>
<contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Thompson</surname>
<given-names>Alex</given-names>
</name>
<address><email>alex.thompson@aspectclinical.com</email>
</address>
<xref ref-type="aff" rid="Aff1"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Reader</surname>
<given-names>Sandie</given-names>
</name>
<xref ref-type="aff" rid="Aff2"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Field</surname>
<given-names>Emma</given-names>
</name>
<xref ref-type="aff" rid="Aff3"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Shephard</surname>
<given-names>Adrian</given-names>
</name>
<xref ref-type="aff" rid="Aff4"></xref>
</contrib>
<aff id="Aff1"><label></label>
Aspect Clinical, 4a Bye Street, Ledbury, Herefordshire HR8 2AA UK</aff>
<aff id="Aff2"><label></label>
Clearcut Clinical Consulting Ltd, 37 Wollaton Vale, Nottingham, UK</aff>
<aff id="Aff3"><label></label>
Reckitt Benckiser Healthcare Ltd, Dansom Lane, Hull, Yorkshire UK</aff>
<aff id="Aff4"><label></label>
Reckitt Benckiser Healthcare Ltd, 103-105 Bath Road, Slough, Berkshire UK</aff>
</contrib-group>
<pub-date pub-type="epub"><day>16</day>
<month>4</month>
<year>2013</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>16</day>
<month>4</month>
<year>2013</year>
</pub-date>
<pub-date pub-type="ppub"><month>6</month>
<year>2013</year>
</pub-date>
<volume>13</volume>
<issue>2</issue>
<fpage>101</fpage>
<lpage>107</lpage>
<permissions><copyright-statement>© The Author(s) 2013</copyright-statement>
<license license-type="OpenAccess"><license-p><bold>Open Access</bold>
This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. The exclusive right to any commercial use of the article is with Springer.</license-p>
</license>
</permissions>
<abstract id="Abs1"><sec><title>Background</title>
<p>Acute sore throat (pharyngitis) is one of the most common illnesses for which children are seen by primary care physicians. Most cases are caused by viruses and are benign and self-limiting. Clinically proven, over-the-counter throat lozenges provide rapid and effective relief of acute sore throat symptoms, and are increasingly important in self-management of this condition.</p>
</sec>
<sec><title>Objective</title>
<p>The purpose of this study (International Standard Randomized Controlled Trial Number: ISRCTN34958871) was to evaluate the acceptability of two licensed, commercially available sore throat lozenges containing amylmetacresol and 2,4-dichlorobenzyl (AMC/DCBA)—one strawberry flavored and the other orange flavored—in healthy children.</p>
</sec>
<sec><title>Study design</title>
<p>This was an open-label, single-dose, crossover, taste-testing study in children recruited via a clinical database and advertisements over a 3.5-week period.</p>
</sec>
<sec><title>Setting</title>
<p>Potentially eligible participants were invited to attend the taste-testing session at a clinic.</p>
</sec>
<sec><title>Participants</title>
<p>At the screening session, which took place either before or on the day of taste testing, details of relevant medical history, medication, and demographics were recorded. Of the 108 screened subjects, 102 were recruited. These were healthy male and female children aged 6–12 years.</p>
</sec>
<sec><title>Intervention</title>
<p>Each child cleansed their palate with water and water biscuits before tasting a strawberry-flavored lozenge (Strepsils<sup>®</sup>
strawberry sugar free, Reckitt Benckiser Healthcare Limited, Nottingham, UK; PL 00063/0395), which was sucked for 1 minute and then expelled. The orange-flavored lozenge (Strepsils<sup>®</sup>
orange with vitamin C, Reckitt Benckiser Healthcare Limited, Nottingham, UK; PL 016242152) was tasted at least 15 minutes later following further cleansing of the palate. The spontaneous reaction of the child on tasting each lozenge was observed and recorded. Subjects were asked to indicate their liking for each lozenge, using a 7-point hedonic facial scale, and were required to answer a series of questions relating to what they liked and disliked about the taste and the feel of the lozenge in the mouth and throat. The primary endpoint was the proportion of subjects with a hedonic facial score of >4. Secondary endpoints included the spontaneous reaction of the child on tasting the lozenge and responses to questions related to taste.</p>
</sec>
<sec><title>Results</title>
<p>The taste of the lozenge was scored >4 (i.e. ‘good’, ‘really good’, or ‘super good’) by 85.3 % of subjects for the strawberry flavor and 49.0 % for the orange flavor (<italic>p</italic>
< 0.0001). The mean (standard deviation) score was 5.72 (1) for the strawberry-flavored lozenge and 4.35 (2) for the orange-flavored lozenge. The proportion of subjects willing to take the lozenge again was 94 % for the strawberry flavor and 56 % for the orange flavor.</p>
</sec>
<sec><title>Conclusions</title>
<p>Strawberry-flavored AMC/DCBA lozenges were liked by, and acceptable to, the majority of the children. AMC/DCBA orange-flavored lozenges were also liked by, and acceptable to, approximately half the children. Overall, both strawberry and orange would be suitable flavors for lozenges intended for children when they suffer from sore throat.</p>
</sec>
</abstract>
<custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name>
<meta-value>© Springer International Publishing Switzerland 2013</meta-value>
</custom-meta>
</custom-meta-group>
</article-meta>
</front>
</pmc>
</record>
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