Ciclesonide in wheezy preschool children with a positive asthma predictive index or atopy
Summary Background Few large-scale studies have examined inhaled corticosteroid treatment in preschool children with recurrent wheeze. We assessed the effects of ciclesonide in preschool children with recurrent wheeze. Methods We included children 2–6 yrs with recurrent wheeze and a positive asthma...
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| Veröffentlicht in: | Respiratory medicine 2011-11, Vol.105 (11), p.1588-1595 |
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| description | Summary Background Few large-scale studies have examined inhaled corticosteroid treatment in preschool children with recurrent wheeze. We assessed the effects of ciclesonide in preschool children with recurrent wheeze. Methods We included children 2–6 yrs with recurrent wheeze and a positive asthma predictive index or aeroallergen sensitization to, excluding patients with episodic viral wheezing. After a 2–4-week baseline period, patients with ongoing symptoms or rescue medication use were randomised to once-daily ciclesonide 40, 80, 160 μg or placebo for 24 weeks. Results The number of wheeze exacerbations requiring systemic corticosteroids was unexpectedly low in all groups: 25 (10.2%) in placebo group, as compared to 11 (4.4%), 18 (7.3%), and 17 (6.7%) in ciclesonide 40, 80, and 160 μg, respectively. The difference in time to first exacerbation was not significantly different between groups ( p = 0.786), but the difference in exacerbation rates between placebo and the pooled ciclesonide groups was ( p = 0.03). Large and significant ( p |
| doi_str_mv | 10.1016/j.rmed.2011.07.017 |
| format | Article |
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We assessed the effects of ciclesonide in preschool children with recurrent wheeze. Methods We included children 2–6 yrs with recurrent wheeze and a positive asthma predictive index or aeroallergen sensitization to, excluding patients with episodic viral wheezing. After a 2–4-week baseline period, patients with ongoing symptoms or rescue medication use were randomised to once-daily ciclesonide 40, 80, 160 μg or placebo for 24 weeks. Results The number of wheeze exacerbations requiring systemic corticosteroids was unexpectedly low in all groups: 25 (10.2%) in placebo group, as compared to 11 (4.4%), 18 (7.3%), and 17 (6.7%) in ciclesonide 40, 80, and 160 μg, respectively. The difference in time to first exacerbation was not significantly different between groups ( p = 0.786), but the difference in exacerbation rates between placebo and the pooled ciclesonide groups was ( p = 0.03). Large and significant ( p < 0.0001) improvements in symptom scores and rescue medication use occurred in all groups, including placebo. Improvements in FEV1 and FEF25–75 (measured in 284 4–6 yr olds) were larger in the ciclesonide than in the placebo group. No differences in safety parameters (adverse events, height growth, serum and urinary cortisol levels) between ciclesonide and placebo were observed. Conclusions In preschool children with recurrent wheeze and a positive asthma predictive index, ciclesonide modestly reduces wheeze exacerbation rates and improves lung function. A large placebo response and unexpected selection of patients with mild disease may have affected outcomes, highlighting the heterogeneity of preschool wheezing disorders.</description><identifier>ISSN: 0954-6111</identifier><identifier>EISSN: 1532-3064</identifier><identifier>DOI: 10.1016/j.rmed.2011.07.017</identifier><identifier>PMID: 21839625</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Adrenal Cortex Hormones - therapeutic use ; Asthma ; Asthma - drug therapy ; Asthma - physiopathology ; Asthma predictive index ; Atopy ; Biological and medical sciences ; Bronchodilator Agents - therapeutic use ; Child ; Child, Preschool ; Children & youth ; Chronic obstructive pulmonary disease, asthma ; Ciclesonide ; Clinical trials ; Disease Progression ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug therapy ; Female ; Forced Expiratory Volume - drug effects ; Humans ; Male ; Medical sciences ; Pneumology ; Predictive Value of Tests ; Pregnenediones - therapeutic use ; Preschool children ; Pulmonary/Respiratory ; Respiratory Sounds - drug effects ; Respiratory Sounds - physiopathology ; Treatment Outcome</subject><ispartof>Respiratory medicine, 2011-11, Vol.105 (11), p.1588-1595</ispartof><rights>Elsevier Ltd</rights><rights>2011 Elsevier Ltd</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c545t-58d87eec5b5d0c1e9edd21f0e423e86e7d5f50cd5115b81a20827128ca6dadc23</citedby><cites>FETCH-LOGICAL-c545t-58d87eec5b5d0c1e9edd21f0e423e86e7d5f50cd5115b81a20827128ca6dadc23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.rmed.2011.07.017$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24552871$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21839625$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Brand, Paul L.P</creatorcontrib><creatorcontrib>Luz García-García, María</creatorcontrib><creatorcontrib>Morison, Adrian</creatorcontrib><creatorcontrib>Vermeulen, Jan H</creatorcontrib><creatorcontrib>Weber, Heinrich C</creatorcontrib><title>Ciclesonide in wheezy preschool children with a positive asthma predictive index or atopy</title><title>Respiratory medicine</title><addtitle>Respir Med</addtitle><description>Summary Background Few large-scale studies have examined inhaled corticosteroid treatment in preschool children with recurrent wheeze. We assessed the effects of ciclesonide in preschool children with recurrent wheeze. Methods We included children 2–6 yrs with recurrent wheeze and a positive asthma predictive index or aeroallergen sensitization to, excluding patients with episodic viral wheezing. After a 2–4-week baseline period, patients with ongoing symptoms or rescue medication use were randomised to once-daily ciclesonide 40, 80, 160 μg or placebo for 24 weeks. Results The number of wheeze exacerbations requiring systemic corticosteroids was unexpectedly low in all groups: 25 (10.2%) in placebo group, as compared to 11 (4.4%), 18 (7.3%), and 17 (6.7%) in ciclesonide 40, 80, and 160 μg, respectively. The difference in time to first exacerbation was not significantly different between groups ( p = 0.786), but the difference in exacerbation rates between placebo and the pooled ciclesonide groups was ( p = 0.03). Large and significant ( p < 0.0001) improvements in symptom scores and rescue medication use occurred in all groups, including placebo. Improvements in FEV1 and FEF25–75 (measured in 284 4–6 yr olds) were larger in the ciclesonide than in the placebo group. No differences in safety parameters (adverse events, height growth, serum and urinary cortisol levels) between ciclesonide and placebo were observed. Conclusions In preschool children with recurrent wheeze and a positive asthma predictive index, ciclesonide modestly reduces wheeze exacerbation rates and improves lung function. A large placebo response and unexpected selection of patients with mild disease may have affected outcomes, highlighting the heterogeneity of preschool wheezing disorders.</description><subject>Adrenal Cortex Hormones - therapeutic use</subject><subject>Asthma</subject><subject>Asthma - drug therapy</subject><subject>Asthma - physiopathology</subject><subject>Asthma predictive index</subject><subject>Atopy</subject><subject>Biological and medical sciences</subject><subject>Bronchodilator Agents - therapeutic use</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Children & youth</subject><subject>Chronic obstructive pulmonary disease, asthma</subject><subject>Ciclesonide</subject><subject>Clinical trials</subject><subject>Disease Progression</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Forced Expiratory Volume - drug effects</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Pneumology</subject><subject>Predictive Value of Tests</subject><subject>Pregnenediones - therapeutic use</subject><subject>Preschool children</subject><subject>Pulmonary/Respiratory</subject><subject>Respiratory Sounds - drug effects</subject><subject>Respiratory Sounds - physiopathology</subject><subject>Treatment Outcome</subject><issn>0954-6111</issn><issn>1532-3064</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kt-L1DAQgIMo3t7pP-CDFETOl9aZtGlTEEEWf8GBD-qDTyGbTGnWblOT7un615u6exzcwz0FMt_MZPINY88QCgSsX2-LsCNbcEAsoCkAmwdshaLkeQl19ZCtoBVVXiPiGTuPcQsAbVXBY3bGUZZtzcWK_Vg7M1D0o7OUuTH73RP9PWRToGh674fM9G6wgVLEzX2ms8lHN7trynSc-51eSOvM_xs3WvqT-ZDp2U-HJ-xRp4dIT0_nBfv-4f239af86svHz-t3V7kRlZhzIa1siIzYCAsGqSVrOXZAFS9J1tRY0QkwViCKjUTNQfIGuTS6ttoaXl6wy2PdKfhfe4qz2rloaBj0SH4flWx5W8mGL-Sre8nUAYG3CFVCX9xBt34fxjSHQigFliXWMlH8SJngYwzUqSm4nQ6HBKlFkdqqRZFaFCloVFKUkp6fSu83S-wm5cZJAl6eAB2NHrqgR-PiLVcJwWWDiXtz5Cj97rWjoKJxNJrkI5CZlfXu_ne8vZNuBje61PEnHSjezqsiV6C-Lsu07BIiABe8Lv8BrWPDgw</recordid><startdate>20111101</startdate><enddate>20111101</enddate><creator>Brand, Paul L.P</creator><creator>Luz García-García, María</creator><creator>Morison, Adrian</creator><creator>Vermeulen, Jan H</creator><creator>Weber, Heinrich C</creator><general>Elsevier Ltd</general><general>Elsevier</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><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>7U9</scope><scope>ASE</scope><scope>FPQ</scope><scope>H94</scope><scope>K6X</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>20111101</creationdate><title>Ciclesonide in wheezy preschool children with a positive asthma predictive index or atopy</title><author>Brand, Paul L.P ; Luz García-García, María ; Morison, Adrian ; Vermeulen, Jan H ; Weber, Heinrich C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c545t-58d87eec5b5d0c1e9edd21f0e423e86e7d5f50cd5115b81a20827128ca6dadc23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adrenal Cortex Hormones - therapeutic use</topic><topic>Asthma</topic><topic>Asthma - drug therapy</topic><topic>Asthma - physiopathology</topic><topic>Asthma predictive index</topic><topic>Atopy</topic><topic>Biological and medical sciences</topic><topic>Bronchodilator Agents - therapeutic use</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Children & youth</topic><topic>Chronic obstructive pulmonary disease, asthma</topic><topic>Ciclesonide</topic><topic>Clinical trials</topic><topic>Disease Progression</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Forced Expiratory Volume - drug effects</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Pneumology</topic><topic>Predictive Value of Tests</topic><topic>Pregnenediones - therapeutic use</topic><topic>Preschool children</topic><topic>Pulmonary/Respiratory</topic><topic>Respiratory Sounds - drug effects</topic><topic>Respiratory Sounds - physiopathology</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Brand, Paul L.P</creatorcontrib><creatorcontrib>Luz García-García, María</creatorcontrib><creatorcontrib>Morison, Adrian</creatorcontrib><creatorcontrib>Vermeulen, Jan H</creatorcontrib><creatorcontrib>Weber, Heinrich C</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><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>Virology and AIDS Abstracts</collection><collection>British Nursing Index</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>British Nursing Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Respiratory medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Brand, Paul L.P</au><au>Luz García-García, María</au><au>Morison, Adrian</au><au>Vermeulen, Jan H</au><au>Weber, Heinrich C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Ciclesonide in wheezy preschool children with a positive asthma predictive index or atopy</atitle><jtitle>Respiratory medicine</jtitle><addtitle>Respir Med</addtitle><date>2011-11-01</date><risdate>2011</risdate><volume>105</volume><issue>11</issue><spage>1588</spage><epage>1595</epage><pages>1588-1595</pages><issn>0954-6111</issn><eissn>1532-3064</eissn><abstract>Summary Background Few large-scale studies have examined inhaled corticosteroid treatment in preschool children with recurrent wheeze. We assessed the effects of ciclesonide in preschool children with recurrent wheeze. Methods We included children 2–6 yrs with recurrent wheeze and a positive asthma predictive index or aeroallergen sensitization to, excluding patients with episodic viral wheezing. After a 2–4-week baseline period, patients with ongoing symptoms or rescue medication use were randomised to once-daily ciclesonide 40, 80, 160 μg or placebo for 24 weeks. Results The number of wheeze exacerbations requiring systemic corticosteroids was unexpectedly low in all groups: 25 (10.2%) in placebo group, as compared to 11 (4.4%), 18 (7.3%), and 17 (6.7%) in ciclesonide 40, 80, and 160 μg, respectively. The difference in time to first exacerbation was not significantly different between groups ( p = 0.786), but the difference in exacerbation rates between placebo and the pooled ciclesonide groups was ( p = 0.03). Large and significant ( p < 0.0001) improvements in symptom scores and rescue medication use occurred in all groups, including placebo. Improvements in FEV1 and FEF25–75 (measured in 284 4–6 yr olds) were larger in the ciclesonide than in the placebo group. No differences in safety parameters (adverse events, height growth, serum and urinary cortisol levels) between ciclesonide and placebo were observed. Conclusions In preschool children with recurrent wheeze and a positive asthma predictive index, ciclesonide modestly reduces wheeze exacerbation rates and improves lung function. A large placebo response and unexpected selection of patients with mild disease may have affected outcomes, highlighting the heterogeneity of preschool wheezing disorders.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>21839625</pmid><doi>10.1016/j.rmed.2011.07.017</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adrenal Cortex Hormones - therapeutic use Asthma Asthma - drug therapy Asthma - physiopathology Asthma predictive index Atopy Biological and medical sciences Bronchodilator Agents - therapeutic use Child Child, Preschool Children & youth Chronic obstructive pulmonary disease, asthma Ciclesonide Clinical trials Disease Progression Dose-Response Relationship, Drug Double-Blind Method Drug therapy Female Forced Expiratory Volume - drug effects Humans Male Medical sciences Pneumology Predictive Value of Tests Pregnenediones - therapeutic use Preschool children Pulmonary/Respiratory Respiratory Sounds - drug effects Respiratory Sounds - physiopathology Treatment Outcome |
| title | Ciclesonide in wheezy preschool children with a positive asthma predictive index or atopy |
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