A dose-ranging study of mometasone furoate aqueous nasal spray in children with seasonal allergic rhinitis
Background: The efficacy and safety of mometasone furoate aqueous nasal spray (MFNS; Nasonex) 200 μg once daily for the treatment and prophylaxis of seasonal allergic rhinitis (SAR) and treatment of perennial rhinitis have been demonstrated in adults. However, the dose response of MFNS in pediatric...
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| Veröffentlicht in: | Journal of allergy and clinical immunology 1999-07, Vol.104 (1), p.107-114 |
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| creator | Meltzer, Eli O. Berger, William E. Berkowitz, Robert B. Bronsky, Edwin A. Dvorin, Donald J. Finn, Albert F. Galant, Stanley P. Grossman, Jay Hampel, Frank C. Ratner, Paul H. Ruff, Michael E. Schenkel, Eric J. Segal, Allen T. Segall, Nathan Stewart, George E. Tripathy, Ita Skoner, David P. Anolik, Robert Dockhorn, Robert J. van Bavel, Julius Mesarina-Wicki, Barbara Nolop, Keith B. |
| description | Background: The efficacy and safety of mometasone furoate aqueous nasal spray (MFNS; Nasonex) 200 μg once daily for the treatment and prophylaxis of seasonal allergic rhinitis (SAR) and treatment of perennial rhinitis have been demonstrated in adults. However, the dose response of MFNS in pediatric patients has not yet been characterized.
Objective: This study was conducted to determine the dose-response relationship of 3 different doses of MFNS in a pediatric population.
Methods: This was a multicenter, double-blind, active- and placebo-controlled study of 679 children 6 to 11 years of age with histories of SAR and documented positive skin test responses. Patients were randomized to one of the following treatment groups for 4 weeks: MFNS 25 μg once daily, MFNS 100 μg once daily, MFNS 200 μg once daily, beclomethasone dipropionate 84 μg twice daily (168 μg/day), or placebo. Physician evaluations were performed at days 4, 8, 15, and 29, and patient evaluations were analyzed for days 1 to 15 and 16 to 29.
Results: The mean reduction from baseline in physician-evaluated total nasal symptom scores at day 8 (the primary efficacy variable) was significantly greater in the MFNS and beclomethasone dipropionate groups than in the placebo group (
P ≤ .02). No significant differences were observed among the 3 MFNS groups. However, as treatment continued, symptoms in patients treated with MFNS 100 or 200 μg once daily continued to improve, whereas those treated with MFNS 25 μg once daily demonstrated little further improvement. By day 29, MFNS 100 and 200 μg once daily both were significantly more effective than MFNS 25 μg once daily in relieving symptoms of SAR, but MFNS 200 μg provided no additional benefit over MFNS 100 μg. All doses of MFNS were well tolerated, and cosyntropin stimulation tests performed before and after treatment found no evidence of hypothalamic-pituitary-adrenal axis suppression.
Conclusion: These results indicate that the most appropriate therapeutic dosage of MFNS in the treatment of SAR in children 6 to 11 years of age is 100 μg once daily. In addition, MFNS at doses up to 200 μg once daily for 4 weeks was well tolerated and had no detectable effects on hypothalamic-pituitary-adrenal axis function. (J Allergy Clin Immunol 1999;104:107-14.) |
| doi_str_mv | 10.1016/S0091-6749(99)70121-1 |
| format | Article |
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Objective: This study was conducted to determine the dose-response relationship of 3 different doses of MFNS in a pediatric population.
Methods: This was a multicenter, double-blind, active- and placebo-controlled study of 679 children 6 to 11 years of age with histories of SAR and documented positive skin test responses. Patients were randomized to one of the following treatment groups for 4 weeks: MFNS 25 μg once daily, MFNS 100 μg once daily, MFNS 200 μg once daily, beclomethasone dipropionate 84 μg twice daily (168 μg/day), or placebo. Physician evaluations were performed at days 4, 8, 15, and 29, and patient evaluations were analyzed for days 1 to 15 and 16 to 29.
Results: The mean reduction from baseline in physician-evaluated total nasal symptom scores at day 8 (the primary efficacy variable) was significantly greater in the MFNS and beclomethasone dipropionate groups than in the placebo group (
P ≤ .02). No significant differences were observed among the 3 MFNS groups. However, as treatment continued, symptoms in patients treated with MFNS 100 or 200 μg once daily continued to improve, whereas those treated with MFNS 25 μg once daily demonstrated little further improvement. By day 29, MFNS 100 and 200 μg once daily both were significantly more effective than MFNS 25 μg once daily in relieving symptoms of SAR, but MFNS 200 μg provided no additional benefit over MFNS 100 μg. All doses of MFNS were well tolerated, and cosyntropin stimulation tests performed before and after treatment found no evidence of hypothalamic-pituitary-adrenal axis suppression.
Conclusion: These results indicate that the most appropriate therapeutic dosage of MFNS in the treatment of SAR in children 6 to 11 years of age is 100 μg once daily. In addition, MFNS at doses up to 200 μg once daily for 4 weeks was well tolerated and had no detectable effects on hypothalamic-pituitary-adrenal axis function. (J Allergy Clin Immunol 1999;104:107-14.)</description><identifier>ISSN: 0091-6749</identifier><identifier>EISSN: 1097-6825</identifier><identifier>DOI: 10.1016/S0091-6749(99)70121-1</identifier><identifier>PMID: 10400847</identifier><identifier>CODEN: JACIBY</identifier><language>eng</language><publisher>New York, NY: Mosby, Inc</publisher><subject>Administration, Intranasal ; Anti-Inflammatory Agents - administration & dosage ; Anti-Inflammatory Agents - pharmacokinetics ; Biological and medical sciences ; Child ; Child, Preschool ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Tolerance ; Ent. Stomatology ; Female ; Glucocorticoids ; Humans ; Male ; Medical sciences ; Mometasone Furoate ; pediatrics ; Pharmacology. Drug treatments ; Placebos ; Pregnadienediols - administration & dosage ; Pregnadienediols - pharmacokinetics ; Rhinitis, Allergic, Seasonal - drug therapy ; Seasonal allergic rhinitis ; Therapeutic Equivalency</subject><ispartof>Journal of allergy and clinical immunology, 1999-07, Vol.104 (1), p.107-114</ispartof><rights>1999 Mosby, Inc.</rights><rights>1999 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c390t-1a5ecdbfaa69a533fef0917b1e4c37067076ebaaa69468489bb9df9bf3d4c23d3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/S0091-6749(99)70121-1$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>315,781,785,3551,27929,27930,46000</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1890109$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/10400847$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Meltzer, Eli O.</creatorcontrib><creatorcontrib>Berger, William E.</creatorcontrib><creatorcontrib>Berkowitz, Robert B.</creatorcontrib><creatorcontrib>Bronsky, Edwin A.</creatorcontrib><creatorcontrib>Dvorin, Donald J.</creatorcontrib><creatorcontrib>Finn, Albert F.</creatorcontrib><creatorcontrib>Galant, Stanley P.</creatorcontrib><creatorcontrib>Grossman, Jay</creatorcontrib><creatorcontrib>Hampel, Frank C.</creatorcontrib><creatorcontrib>Ratner, Paul H.</creatorcontrib><creatorcontrib>Ruff, Michael E.</creatorcontrib><creatorcontrib>Schenkel, Eric J.</creatorcontrib><creatorcontrib>Segal, Allen T.</creatorcontrib><creatorcontrib>Segall, Nathan</creatorcontrib><creatorcontrib>Stewart, George E.</creatorcontrib><creatorcontrib>Tripathy, Ita</creatorcontrib><creatorcontrib>Skoner, David P.</creatorcontrib><creatorcontrib>Anolik, Robert</creatorcontrib><creatorcontrib>Dockhorn, Robert J.</creatorcontrib><creatorcontrib>van Bavel, Julius</creatorcontrib><creatorcontrib>Mesarina-Wicki, Barbara</creatorcontrib><creatorcontrib>Nolop, Keith B.</creatorcontrib><title>A dose-ranging study of mometasone furoate aqueous nasal spray in children with seasonal allergic rhinitis</title><title>Journal of allergy and clinical immunology</title><addtitle>J Allergy Clin Immunol</addtitle><description>Background: The efficacy and safety of mometasone furoate aqueous nasal spray (MFNS; Nasonex) 200 μg once daily for the treatment and prophylaxis of seasonal allergic rhinitis (SAR) and treatment of perennial rhinitis have been demonstrated in adults. However, the dose response of MFNS in pediatric patients has not yet been characterized.
Objective: This study was conducted to determine the dose-response relationship of 3 different doses of MFNS in a pediatric population.
Methods: This was a multicenter, double-blind, active- and placebo-controlled study of 679 children 6 to 11 years of age with histories of SAR and documented positive skin test responses. Patients were randomized to one of the following treatment groups for 4 weeks: MFNS 25 μg once daily, MFNS 100 μg once daily, MFNS 200 μg once daily, beclomethasone dipropionate 84 μg twice daily (168 μg/day), or placebo. Physician evaluations were performed at days 4, 8, 15, and 29, and patient evaluations were analyzed for days 1 to 15 and 16 to 29.
Results: The mean reduction from baseline in physician-evaluated total nasal symptom scores at day 8 (the primary efficacy variable) was significantly greater in the MFNS and beclomethasone dipropionate groups than in the placebo group (
P ≤ .02). No significant differences were observed among the 3 MFNS groups. However, as treatment continued, symptoms in patients treated with MFNS 100 or 200 μg once daily continued to improve, whereas those treated with MFNS 25 μg once daily demonstrated little further improvement. By day 29, MFNS 100 and 200 μg once daily both were significantly more effective than MFNS 25 μg once daily in relieving symptoms of SAR, but MFNS 200 μg provided no additional benefit over MFNS 100 μg. All doses of MFNS were well tolerated, and cosyntropin stimulation tests performed before and after treatment found no evidence of hypothalamic-pituitary-adrenal axis suppression.
Conclusion: These results indicate that the most appropriate therapeutic dosage of MFNS in the treatment of SAR in children 6 to 11 years of age is 100 μg once daily. In addition, MFNS at doses up to 200 μg once daily for 4 weeks was well tolerated and had no detectable effects on hypothalamic-pituitary-adrenal axis function. (J Allergy Clin Immunol 1999;104:107-14.)</description><subject>Administration, Intranasal</subject><subject>Anti-Inflammatory Agents - administration & dosage</subject><subject>Anti-Inflammatory Agents - pharmacokinetics</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug Tolerance</subject><subject>Ent. Stomatology</subject><subject>Female</subject><subject>Glucocorticoids</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Mometasone Furoate</subject><subject>pediatrics</subject><subject>Pharmacology. Drug treatments</subject><subject>Placebos</subject><subject>Pregnadienediols - administration & dosage</subject><subject>Pregnadienediols - pharmacokinetics</subject><subject>Rhinitis, Allergic, Seasonal - drug therapy</subject><subject>Seasonal allergic rhinitis</subject><subject>Therapeutic Equivalency</subject><issn>0091-6749</issn><issn>1097-6825</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1999</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU1r3DAQhkVJaTbb_oQUHUJID26ltde2TiGEfkGgh7ZnMZZGuwq2tNHYDfvvK2eXNLeehJhnRu88Yuxcio9SyPrTTyGULOqmUldKfWiEXMlCvmILKVRT1O1qfcIWz8gpOyO6F_letuoNO5WiEqKtmgW7v-E2EhYJwsaHDadxsnseHR_igCNQDMjdlCKMyOFhwjgRD0DQc9ol2HMfuNn63iYM_NGPW044N-U69D2mjTc8bX3wo6e37LWDnvDd8Vyy318-_7r9Vtz9-Pr99uauMKUSYyFhjcZ2DqBWsC5Lhy6v0XQSK1M2om5EU2MHc7mq26pVXaesU50rbWVWpS2X7PIwd5diTkyjHjwZ7HsIc3xdq7ZVqzx5ydYH0KRIlNDpXfIDpL2WQs-S9ZNkPRvUSuknyVrmvvfHB6ZuQPui62A1AxdHAMhA77Jc4-kf1yqRvylj1wcMs40_HpMm4zEYtD6hGbWN_j9J_gKMvps8</recordid><startdate>19990701</startdate><enddate>19990701</enddate><creator>Meltzer, Eli O.</creator><creator>Berger, William E.</creator><creator>Berkowitz, Robert B.</creator><creator>Bronsky, Edwin A.</creator><creator>Dvorin, Donald J.</creator><creator>Finn, Albert F.</creator><creator>Galant, Stanley P.</creator><creator>Grossman, Jay</creator><creator>Hampel, Frank C.</creator><creator>Ratner, Paul H.</creator><creator>Ruff, Michael E.</creator><creator>Schenkel, Eric J.</creator><creator>Segal, Allen T.</creator><creator>Segall, Nathan</creator><creator>Stewart, George E.</creator><creator>Tripathy, Ita</creator><creator>Skoner, David P.</creator><creator>Anolik, Robert</creator><creator>Dockhorn, Robert J.</creator><creator>van Bavel, Julius</creator><creator>Mesarina-Wicki, Barbara</creator><creator>Nolop, Keith B.</creator><general>Mosby, Inc</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>19990701</creationdate><title>A dose-ranging study of mometasone furoate aqueous nasal spray in children with seasonal allergic rhinitis</title><author>Meltzer, Eli O. ; Berger, William E. ; Berkowitz, Robert B. ; Bronsky, Edwin A. ; Dvorin, Donald J. ; Finn, Albert F. ; Galant, Stanley P. ; Grossman, Jay ; Hampel, Frank C. ; Ratner, Paul H. ; Ruff, Michael E. ; Schenkel, Eric J. ; Segal, Allen T. ; Segall, Nathan ; Stewart, George E. ; Tripathy, Ita ; Skoner, David P. ; Anolik, Robert ; Dockhorn, Robert J. ; van Bavel, Julius ; Mesarina-Wicki, Barbara ; Nolop, Keith B.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c390t-1a5ecdbfaa69a533fef0917b1e4c37067076ebaaa69468489bb9df9bf3d4c23d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1999</creationdate><topic>Administration, Intranasal</topic><topic>Anti-Inflammatory Agents - administration & dosage</topic><topic>Anti-Inflammatory Agents - pharmacokinetics</topic><topic>Biological and medical sciences</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug Tolerance</topic><topic>Ent. Stomatology</topic><topic>Female</topic><topic>Glucocorticoids</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Mometasone Furoate</topic><topic>pediatrics</topic><topic>Pharmacology. Drug treatments</topic><topic>Placebos</topic><topic>Pregnadienediols - administration & dosage</topic><topic>Pregnadienediols - pharmacokinetics</topic><topic>Rhinitis, Allergic, Seasonal - drug therapy</topic><topic>Seasonal allergic rhinitis</topic><topic>Therapeutic Equivalency</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Meltzer, Eli O.</creatorcontrib><creatorcontrib>Berger, William E.</creatorcontrib><creatorcontrib>Berkowitz, Robert B.</creatorcontrib><creatorcontrib>Bronsky, Edwin A.</creatorcontrib><creatorcontrib>Dvorin, Donald J.</creatorcontrib><creatorcontrib>Finn, Albert F.</creatorcontrib><creatorcontrib>Galant, Stanley P.</creatorcontrib><creatorcontrib>Grossman, Jay</creatorcontrib><creatorcontrib>Hampel, Frank C.</creatorcontrib><creatorcontrib>Ratner, Paul H.</creatorcontrib><creatorcontrib>Ruff, Michael E.</creatorcontrib><creatorcontrib>Schenkel, Eric J.</creatorcontrib><creatorcontrib>Segal, Allen T.</creatorcontrib><creatorcontrib>Segall, Nathan</creatorcontrib><creatorcontrib>Stewart, George E.</creatorcontrib><creatorcontrib>Tripathy, Ita</creatorcontrib><creatorcontrib>Skoner, David P.</creatorcontrib><creatorcontrib>Anolik, Robert</creatorcontrib><creatorcontrib>Dockhorn, Robert J.</creatorcontrib><creatorcontrib>van Bavel, Julius</creatorcontrib><creatorcontrib>Mesarina-Wicki, Barbara</creatorcontrib><creatorcontrib>Nolop, Keith B.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of allergy and clinical immunology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Meltzer, Eli O.</au><au>Berger, William E.</au><au>Berkowitz, Robert B.</au><au>Bronsky, Edwin A.</au><au>Dvorin, Donald J.</au><au>Finn, Albert F.</au><au>Galant, Stanley P.</au><au>Grossman, Jay</au><au>Hampel, Frank C.</au><au>Ratner, Paul H.</au><au>Ruff, Michael E.</au><au>Schenkel, Eric J.</au><au>Segal, Allen T.</au><au>Segall, Nathan</au><au>Stewart, George E.</au><au>Tripathy, Ita</au><au>Skoner, David P.</au><au>Anolik, Robert</au><au>Dockhorn, Robert J.</au><au>van Bavel, Julius</au><au>Mesarina-Wicki, Barbara</au><au>Nolop, Keith B.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A dose-ranging study of mometasone furoate aqueous nasal spray in children with seasonal allergic rhinitis</atitle><jtitle>Journal of allergy and clinical immunology</jtitle><addtitle>J Allergy Clin Immunol</addtitle><date>1999-07-01</date><risdate>1999</risdate><volume>104</volume><issue>1</issue><spage>107</spage><epage>114</epage><pages>107-114</pages><issn>0091-6749</issn><eissn>1097-6825</eissn><coden>JACIBY</coden><abstract>Background: The efficacy and safety of mometasone furoate aqueous nasal spray (MFNS; Nasonex) 200 μg once daily for the treatment and prophylaxis of seasonal allergic rhinitis (SAR) and treatment of perennial rhinitis have been demonstrated in adults. However, the dose response of MFNS in pediatric patients has not yet been characterized.
Objective: This study was conducted to determine the dose-response relationship of 3 different doses of MFNS in a pediatric population.
Methods: This was a multicenter, double-blind, active- and placebo-controlled study of 679 children 6 to 11 years of age with histories of SAR and documented positive skin test responses. Patients were randomized to one of the following treatment groups for 4 weeks: MFNS 25 μg once daily, MFNS 100 μg once daily, MFNS 200 μg once daily, beclomethasone dipropionate 84 μg twice daily (168 μg/day), or placebo. Physician evaluations were performed at days 4, 8, 15, and 29, and patient evaluations were analyzed for days 1 to 15 and 16 to 29.
Results: The mean reduction from baseline in physician-evaluated total nasal symptom scores at day 8 (the primary efficacy variable) was significantly greater in the MFNS and beclomethasone dipropionate groups than in the placebo group (
P ≤ .02). No significant differences were observed among the 3 MFNS groups. However, as treatment continued, symptoms in patients treated with MFNS 100 or 200 μg once daily continued to improve, whereas those treated with MFNS 25 μg once daily demonstrated little further improvement. By day 29, MFNS 100 and 200 μg once daily both were significantly more effective than MFNS 25 μg once daily in relieving symptoms of SAR, but MFNS 200 μg provided no additional benefit over MFNS 100 μg. All doses of MFNS were well tolerated, and cosyntropin stimulation tests performed before and after treatment found no evidence of hypothalamic-pituitary-adrenal axis suppression.
Conclusion: These results indicate that the most appropriate therapeutic dosage of MFNS in the treatment of SAR in children 6 to 11 years of age is 100 μg once daily. In addition, MFNS at doses up to 200 μg once daily for 4 weeks was well tolerated and had no detectable effects on hypothalamic-pituitary-adrenal axis function. (J Allergy Clin Immunol 1999;104:107-14.)</abstract><cop>New York, NY</cop><pub>Mosby, Inc</pub><pmid>10400847</pmid><doi>10.1016/S0091-6749(99)70121-1</doi><tpages>8</tpages></addata></record> |
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| ispartof | Journal of allergy and clinical immunology, 1999-07, Vol.104 (1), p.107-114 |
| issn | 0091-6749 1097-6825 |
| language | eng |
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| source | MEDLINE; Access via ScienceDirect (Elsevier); EZB-FREE-00999 freely available EZB journals |
| subjects | Administration, Intranasal Anti-Inflammatory Agents - administration & dosage Anti-Inflammatory Agents - pharmacokinetics Biological and medical sciences Child Child, Preschool Dose-Response Relationship, Drug Double-Blind Method Drug Tolerance Ent. Stomatology Female Glucocorticoids Humans Male Medical sciences Mometasone Furoate pediatrics Pharmacology. Drug treatments Placebos Pregnadienediols - administration & dosage Pregnadienediols - pharmacokinetics Rhinitis, Allergic, Seasonal - drug therapy Seasonal allergic rhinitis Therapeutic Equivalency |
| title | A dose-ranging study of mometasone furoate aqueous nasal spray in children with seasonal allergic rhinitis |
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