Growth, systemic safety, and efficacy during 1 year of asthma treatment with different beclomethasone dipropionate formulations: an open-label, randomized comparison of extrafine and conventional aerosols in children.
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| Title: | Growth, systemic safety, and efficacy during 1 year of asthma treatment with different beclomethasone dipropionate formulations: an open-label, randomized comparison of extrafine and conventional aerosols in children. |
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| Authors: | Pedersen S (AUTHOR), Warner J (AUTHOR), Wahn U (AUTHOR), Staab D (AUTHOR), Le Bourgeois M (AUTHOR), Van Essen-Zandvliet E (AUTHOR), Arora S (AUTHOR), Szefler SJ (AUTHOR), Pediatric Study Group (CORPORATE AUTHOR) |
| Source: | Pediatrics. Jun2002, Vol. 109 Issue 6, p10p-10p. 1p. |
| Abstract: | OBJECTIVE: To assess the long-term safety of hydrofluoroalkane 134a (HFA)-beclomethasone dipropionate (BDP) extrafine aerosol administered by the Autohaler compared with chlorofluorocarbon (CFC)-BDP administered by a press-and-breathe metered-dose inhaler (pMDI) and spacer (+S) in the treatment of children with asthma. METHODS: This 12-month, open-label, randomized, multicenter study enrolled 300 children who were aged 5 to 11 years and had well-controlled asthma on inhaled CFC-BDP or budesonide; 256 patients were using doses within the recommended range (200-400 microg) and were analyzed separately. Patients were randomized in a 1:3 ratio to continue on CFC-BDP+S at approximately the same dose as they were using before study entry or switch to HFA-BDP at half the daily dose. RESULTS: Asthma control was well maintained in the HFA-BDP group as evidenced by lung function tests and asthma symptoms compared with CFC-BDP+S at approximately twice the dose. There were no significant differences between the HFA-BDP 100 to 200 microg and CFC-BDP+S 200 to 400 microg treatment groups in mean change from baseline in height (5.23 cm vs 5.66 cm at month 12, respectively) or mean growth velocity from day 1 to month 12 (5.27 cm/y vs 5.71 cm/y, respectively). There were no significant differences between groups in adrenal function tests or markers of bone metabolism. CONCLUSIONS: In this long-term study in children with asthma, extrafine HFA-BDP provided long-term maintenance of asthma control at approximately half the dose compared with CFC-BDP+S. There were no clinically meaningful differences between HFA-BDP extrafine aerosol and conventional CFC-BDP+S with regard to growth or other systemic effects. [Abstract for this article also available on page 1164 of printed version. Full article available at http://www.pediatrics.org/cgi/content/full/106/6/e92] [ABSTRACT FROM AUTHOR] |
| Copyright of Pediatrics is the property of American Academy of Pediatrics and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
| FullText | Text: Availability: 0 |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 106832555 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Growth, systemic safety, and efficacy during 1 year of asthma treatment with different beclomethasone dipropionate formulations: an open-label, randomized comparison of extrafine and conventional aerosols in children. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Pedersen+S%22">Pedersen S</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Warner+J%22">Warner J</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wahn+U%22">Wahn U</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Staab+D%22">Staab D</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Le+Bourgeois+M%22">Le Bourgeois M</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Van+Essen-Zandvliet+E%22">Van Essen-Zandvliet E</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Arora+S%22">Arora S</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Szefler+SJ%22">Szefler SJ</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pediatric+Study+Group%22">Pediatric Study Group</searchLink> (CORPORATE AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Pediatrics%22">Pediatrics</searchLink>. Jun2002, Vol. 109 Issue 6, p10p-10p. 1p. – Name: Abstract Label: Abstract Group: Ab Data: OBJECTIVE: To assess the long-term safety of hydrofluoroalkane 134a (HFA)-beclomethasone dipropionate (BDP) extrafine aerosol administered by the Autohaler compared with chlorofluorocarbon (CFC)-BDP administered by a press-and-breathe metered-dose inhaler (pMDI) and spacer (+S) in the treatment of children with asthma. METHODS: This 12-month, open-label, randomized, multicenter study enrolled 300 children who were aged 5 to 11 years and had well-controlled asthma on inhaled CFC-BDP or budesonide; 256 patients were using doses within the recommended range (200-400 microg) and were analyzed separately. Patients were randomized in a 1:3 ratio to continue on CFC-BDP+S at approximately the same dose as they were using before study entry or switch to HFA-BDP at half the daily dose. RESULTS: Asthma control was well maintained in the HFA-BDP group as evidenced by lung function tests and asthma symptoms compared with CFC-BDP+S at approximately twice the dose. There were no significant differences between the HFA-BDP 100 to 200 microg and CFC-BDP+S 200 to 400 microg treatment groups in mean change from baseline in height (5.23 cm vs 5.66 cm at month 12, respectively) or mean growth velocity from day 1 to month 12 (5.27 cm/y vs 5.71 cm/y, respectively). There were no significant differences between groups in adrenal function tests or markers of bone metabolism. CONCLUSIONS: In this long-term study in children with asthma, extrafine HFA-BDP provided long-term maintenance of asthma control at approximately half the dose compared with CFC-BDP+S. There were no clinically meaningful differences between HFA-BDP extrafine aerosol and conventional CFC-BDP+S with regard to growth or other systemic effects. [Abstract for this article also available on page 1164 of printed version. Full article available at http://www.pediatrics.org/cgi/content/full/106/6/e92] [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Pediatrics is the property of American Academy of Pediatrics and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1542/peds.109.6.e92 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 1 StartPage: 10p Titles: – TitleFull: Growth, systemic safety, and efficacy during 1 year of asthma treatment with different beclomethasone dipropionate formulations: an open-label, randomized comparison of extrafine and conventional aerosols in children. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Pedersen S – PersonEntity: Name: NameFull: Warner J – PersonEntity: Name: NameFull: Wahn U – PersonEntity: Name: NameFull: Staab D – PersonEntity: Name: NameFull: Le Bourgeois M – PersonEntity: Name: NameFull: Van Essen-Zandvliet E – PersonEntity: Name: NameFull: Arora S – PersonEntity: Name: NameFull: Szefler SJ – PersonEntity: Name: NameFull: Pediatric Study Group IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 06 Text: Jun2002 Type: published Y: 2002 Identifiers: – Type: issn-print Value: 00314005 Numbering: – Type: volume Value: 109 – Type: issue Value: 6 Titles: – TitleFull: Pediatrics Type: main |
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