Once-daily budesonide inhalation powder (Pulmicort Turbuhaler) maintains pulmonary function and symptoms of asthmatic children previously receiving inhaled corticosteroids
The incidence of pediatric asthma has increased dramatically over the past few decades, with approximately 5% of American children affected by the disease. To compare the efficacy and safety of once-daily budesonide Turbuhaler with placebo in asthmatic children previously treated with orally inhaled...
Gespeichert in:
| Veröffentlicht in: | Annals of allergy, asthma, & immunology asthma, & immunology, 2001-06, Vol.86 (6), p.633-640 |
|---|---|
| Hauptverfasser: | , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 640 |
|---|---|
| container_issue | 6 |
| container_start_page | 633 |
| container_title | Annals of allergy, asthma, & immunology |
| container_volume | 86 |
| creator | Shapiro, Gail G. Mendelson, Louis M. Pearlman, David S. |
| description | The incidence of pediatric asthma has increased dramatically over the past few decades, with approximately 5% of American children affected by the disease.
To compare the efficacy and safety of once-daily budesonide Turbuhaler with placebo in asthmatic children previously treated with orally inhaled corticosteroids.
This randomized, double-blind, placebo-controlled, multicenter (17 centers) study included 274 male and female children (aged 6 to 17 years) with a history of asthma for at least the previous 6 months. Patients received placebo or budesonide Turbuhaler (200 μg or 400 μg) once daily for 12 weeks. Efficacy variables included mean changes from baseline in forced expiratory volume in 1 second (FEV
1),
am and
pm peak expiratory flow rates (PEFRs), nighttime and daytime asthma symptom severity scores, patient discontinuations, use of β
2-agonists as breakthrough medication, forced vital capacity (FVC), and midexpiratory flow rate between 25% and 75% of FVC (FEF
25%-75%). Safety was evaluated by adverse events, physical examinations, vital signs, and laboratory tests.
Baseline characteristics were comparable among treatment groups. Percentage of predicted FEV
1 at baseline was 76.6 ± 6.9 for placebo, 77.5 ± 7.1, and 77.0 ± 7.8 for the budesonide Turbuhaler 200 μg and 400 μg groups, respectively. Significantly (
P ≤ 0.024) more placebo patients (24%) discontinued treatment because of disease deterioration or no improvement than budesonide Turbuhaler 200 μg (11%) or 400 μg patients (10%). Patients receiving budesonide Turbuhaler experienced significant improvements in FEV
1 compared with patients receiving placebo (
P ≤ 0.015). Significant (
P ≤ 0.041) improvements over placebo also were observed in
am and
pm PEFRs, FVC, FEF
25%-75%, nighttime and daytime asthma symptoms, and amount of β
2-agonist used in both budesonide Turbuhaler groups. Adverse events were generally mild or moderate in intensity and similar among treatment groups.
Once-daily budesonide Turbuhaler is effective and safe in children with persistent asthma previously maintained on at least twice-daily dosing regimens of inhaled corticosteroids. |
| doi_str_mv | 10.1016/S1081-1206(10)62291-0 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_70962637</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S1081120610622910</els_id><sourcerecordid>74810124</sourcerecordid><originalsourceid>FETCH-LOGICAL-c417t-9f80010891b2a8d9b544e98d3d2a6111d241c8df356737d072a3eba422993fa13</originalsourceid><addsrcrecordid>eNqFkdtqFTEUhgdRbK0-ghJESnsxmpXMIXMlUjxBoYL1OmSSNe6UmWSbzGzZz9SXdO2DKN54ERKSb_3_yvqL4jnw18ChefMVuIISBG8ugF82QnRQ8gfFKdSyKqtKNg_p_Bs5KZ7kfMc5B9XIx8UJQCVUK-vT4v4mWCyd8eOW9YvDHIN3yHxYmdHMPga2jj8dJnbxZRknb2Oa2e2S-oXeMV2yyfgw08psTe8xmLRlwxLsvtQEx_J2Ws9xyiwOzOR5NZGqZXblR5eQ1BNufFwy2Se06Dc-fD-4o2M7N7LMM6boXX5aPBrMmPHZcT8rvn14f3v1qby--fj56t11aSto57IbFH2Uqw56YZTr-rqqsFNOOmEaAHCiAqvcIOumla3jrTASe1PRCDs5GJBnxflBd53ijwXzrCefLY6jCUit6pZ3jWhkS-DLf8C7uKRAvWnBRatkLRRB9QGyKeaccNDr5Ceakwaud1HqfZR6l9Puah-l5lT34ii-9BO6P1XH7Ah4dQRMtmYckgnW57_UBbl3hL09YEgj23hMOluPlLrzNPFZu-j_08kvHie-mQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>202783528</pqid></control><display><type>article</type><title>Once-daily budesonide inhalation powder (Pulmicort Turbuhaler) maintains pulmonary function and symptoms of asthmatic children previously receiving inhaled corticosteroids</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Shapiro, Gail G. ; Mendelson, Louis M. ; Pearlman, David S.</creator><creatorcontrib>Shapiro, Gail G. ; Mendelson, Louis M. ; Pearlman, David S.</creatorcontrib><description>The incidence of pediatric asthma has increased dramatically over the past few decades, with approximately 5% of American children affected by the disease.
To compare the efficacy and safety of once-daily budesonide Turbuhaler with placebo in asthmatic children previously treated with orally inhaled corticosteroids.
This randomized, double-blind, placebo-controlled, multicenter (17 centers) study included 274 male and female children (aged 6 to 17 years) with a history of asthma for at least the previous 6 months. Patients received placebo or budesonide Turbuhaler (200 μg or 400 μg) once daily for 12 weeks. Efficacy variables included mean changes from baseline in forced expiratory volume in 1 second (FEV
1),
am and
pm peak expiratory flow rates (PEFRs), nighttime and daytime asthma symptom severity scores, patient discontinuations, use of β
2-agonists as breakthrough medication, forced vital capacity (FVC), and midexpiratory flow rate between 25% and 75% of FVC (FEF
25%-75%). Safety was evaluated by adverse events, physical examinations, vital signs, and laboratory tests.
Baseline characteristics were comparable among treatment groups. Percentage of predicted FEV
1 at baseline was 76.6 ± 6.9 for placebo, 77.5 ± 7.1, and 77.0 ± 7.8 for the budesonide Turbuhaler 200 μg and 400 μg groups, respectively. Significantly (
P ≤ 0.024) more placebo patients (24%) discontinued treatment because of disease deterioration or no improvement than budesonide Turbuhaler 200 μg (11%) or 400 μg patients (10%). Patients receiving budesonide Turbuhaler experienced significant improvements in FEV
1 compared with patients receiving placebo (
P ≤ 0.015). Significant (
P ≤ 0.041) improvements over placebo also were observed in
am and
pm PEFRs, FVC, FEF
25%-75%, nighttime and daytime asthma symptoms, and amount of β
2-agonist used in both budesonide Turbuhaler groups. Adverse events were generally mild or moderate in intensity and similar among treatment groups.
Once-daily budesonide Turbuhaler is effective and safe in children with persistent asthma previously maintained on at least twice-daily dosing regimens of inhaled corticosteroids.</description><identifier>ISSN: 1081-1206</identifier><identifier>EISSN: 1534-4436</identifier><identifier>DOI: 10.1016/S1081-1206(10)62291-0</identifier><identifier>PMID: 11428735</identifier><identifier>CODEN: ANAEA3</identifier><language>eng</language><publisher>McLean, VA: Elsevier Inc</publisher><subject>Administration, Inhalation ; Adolescent ; Adult ; Aged ; Anti-Inflammatory Agents - administration & dosage ; Anti-Inflammatory Agents - therapeutic use ; Biological and medical sciences ; Budesonide - administration & dosage ; Budesonide - therapeutic use ; Drug Administration Schedule ; Female ; Forced Expiratory Volume ; Humans ; Male ; Medical sciences ; Middle Aged ; Peak Expiratory Flow Rate ; Pharmacology. Drug treatments ; Respiratory system</subject><ispartof>Annals of allergy, asthma, & immunology, 2001-06, Vol.86 (6), p.633-640</ispartof><rights>2001 American College of Allergy, Asthma & Immunology</rights><rights>2001 INIST-CNRS</rights><rights>Copyright American College of Allergy and Immunology Jun 2001</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c417t-9f80010891b2a8d9b544e98d3d2a6111d241c8df356737d072a3eba422993fa13</citedby><cites>FETCH-LOGICAL-c417t-9f80010891b2a8d9b544e98d3d2a6111d241c8df356737d072a3eba422993fa13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1081120610622910$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3536,27903,27904,65309</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1022839$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11428735$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shapiro, Gail G.</creatorcontrib><creatorcontrib>Mendelson, Louis M.</creatorcontrib><creatorcontrib>Pearlman, David S.</creatorcontrib><title>Once-daily budesonide inhalation powder (Pulmicort Turbuhaler) maintains pulmonary function and symptoms of asthmatic children previously receiving inhaled corticosteroids</title><title>Annals of allergy, asthma, & immunology</title><addtitle>Ann Allergy Asthma Immunol</addtitle><description>The incidence of pediatric asthma has increased dramatically over the past few decades, with approximately 5% of American children affected by the disease.
To compare the efficacy and safety of once-daily budesonide Turbuhaler with placebo in asthmatic children previously treated with orally inhaled corticosteroids.
This randomized, double-blind, placebo-controlled, multicenter (17 centers) study included 274 male and female children (aged 6 to 17 years) with a history of asthma for at least the previous 6 months. Patients received placebo or budesonide Turbuhaler (200 μg or 400 μg) once daily for 12 weeks. Efficacy variables included mean changes from baseline in forced expiratory volume in 1 second (FEV
1),
am and
pm peak expiratory flow rates (PEFRs), nighttime and daytime asthma symptom severity scores, patient discontinuations, use of β
2-agonists as breakthrough medication, forced vital capacity (FVC), and midexpiratory flow rate between 25% and 75% of FVC (FEF
25%-75%). Safety was evaluated by adverse events, physical examinations, vital signs, and laboratory tests.
Baseline characteristics were comparable among treatment groups. Percentage of predicted FEV
1 at baseline was 76.6 ± 6.9 for placebo, 77.5 ± 7.1, and 77.0 ± 7.8 for the budesonide Turbuhaler 200 μg and 400 μg groups, respectively. Significantly (
P ≤ 0.024) more placebo patients (24%) discontinued treatment because of disease deterioration or no improvement than budesonide Turbuhaler 200 μg (11%) or 400 μg patients (10%). Patients receiving budesonide Turbuhaler experienced significant improvements in FEV
1 compared with patients receiving placebo (
P ≤ 0.015). Significant (
P ≤ 0.041) improvements over placebo also were observed in
am and
pm PEFRs, FVC, FEF
25%-75%, nighttime and daytime asthma symptoms, and amount of β
2-agonist used in both budesonide Turbuhaler groups. Adverse events were generally mild or moderate in intensity and similar among treatment groups.
Once-daily budesonide Turbuhaler is effective and safe in children with persistent asthma previously maintained on at least twice-daily dosing regimens of inhaled corticosteroids.</description><subject>Administration, Inhalation</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Anti-Inflammatory Agents - administration & dosage</subject><subject>Anti-Inflammatory Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Budesonide - administration & dosage</subject><subject>Budesonide - therapeutic use</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Forced Expiratory Volume</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Peak Expiratory Flow Rate</subject><subject>Pharmacology. Drug treatments</subject><subject>Respiratory system</subject><issn>1081-1206</issn><issn>1534-4436</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2001</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkdtqFTEUhgdRbK0-ghJESnsxmpXMIXMlUjxBoYL1OmSSNe6UmWSbzGzZz9SXdO2DKN54ERKSb_3_yvqL4jnw18ChefMVuIISBG8ugF82QnRQ8gfFKdSyKqtKNg_p_Bs5KZ7kfMc5B9XIx8UJQCVUK-vT4v4mWCyd8eOW9YvDHIN3yHxYmdHMPga2jj8dJnbxZRknb2Oa2e2S-oXeMV2yyfgw08psTe8xmLRlwxLsvtQEx_J2Ws9xyiwOzOR5NZGqZXblR5eQ1BNufFwy2Se06Dc-fD-4o2M7N7LMM6boXX5aPBrMmPHZcT8rvn14f3v1qby--fj56t11aSto57IbFH2Uqw56YZTr-rqqsFNOOmEaAHCiAqvcIOumla3jrTASe1PRCDs5GJBnxflBd53ijwXzrCefLY6jCUit6pZ3jWhkS-DLf8C7uKRAvWnBRatkLRRB9QGyKeaccNDr5Ceakwaud1HqfZR6l9Puah-l5lT34ii-9BO6P1XH7Ah4dQRMtmYckgnW57_UBbl3hL09YEgj23hMOluPlLrzNPFZu-j_08kvHie-mQ</recordid><startdate>20010601</startdate><enddate>20010601</enddate><creator>Shapiro, Gail G.</creator><creator>Mendelson, Louis M.</creator><creator>Pearlman, David S.</creator><general>Elsevier Inc</general><general>American College of Allergy, Asthma, & Immunology</general><general>American College of Allergy and Immunology</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>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>20010601</creationdate><title>Once-daily budesonide inhalation powder (Pulmicort Turbuhaler) maintains pulmonary function and symptoms of asthmatic children previously receiving inhaled corticosteroids</title><author>Shapiro, Gail G. ; Mendelson, Louis M. ; Pearlman, David S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c417t-9f80010891b2a8d9b544e98d3d2a6111d241c8df356737d072a3eba422993fa13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2001</creationdate><topic>Administration, Inhalation</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Anti-Inflammatory Agents - administration & dosage</topic><topic>Anti-Inflammatory Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Budesonide - administration & dosage</topic><topic>Budesonide - therapeutic use</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Forced Expiratory Volume</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Peak Expiratory Flow Rate</topic><topic>Pharmacology. Drug treatments</topic><topic>Respiratory system</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shapiro, Gail G.</creatorcontrib><creatorcontrib>Mendelson, Louis M.</creatorcontrib><creatorcontrib>Pearlman, David S.</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>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Annals of allergy, asthma, & immunology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shapiro, Gail G.</au><au>Mendelson, Louis M.</au><au>Pearlman, David S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Once-daily budesonide inhalation powder (Pulmicort Turbuhaler) maintains pulmonary function and symptoms of asthmatic children previously receiving inhaled corticosteroids</atitle><jtitle>Annals of allergy, asthma, & immunology</jtitle><addtitle>Ann Allergy Asthma Immunol</addtitle><date>2001-06-01</date><risdate>2001</risdate><volume>86</volume><issue>6</issue><spage>633</spage><epage>640</epage><pages>633-640</pages><issn>1081-1206</issn><eissn>1534-4436</eissn><coden>ANAEA3</coden><abstract>The incidence of pediatric asthma has increased dramatically over the past few decades, with approximately 5% of American children affected by the disease.
To compare the efficacy and safety of once-daily budesonide Turbuhaler with placebo in asthmatic children previously treated with orally inhaled corticosteroids.
This randomized, double-blind, placebo-controlled, multicenter (17 centers) study included 274 male and female children (aged 6 to 17 years) with a history of asthma for at least the previous 6 months. Patients received placebo or budesonide Turbuhaler (200 μg or 400 μg) once daily for 12 weeks. Efficacy variables included mean changes from baseline in forced expiratory volume in 1 second (FEV
1),
am and
pm peak expiratory flow rates (PEFRs), nighttime and daytime asthma symptom severity scores, patient discontinuations, use of β
2-agonists as breakthrough medication, forced vital capacity (FVC), and midexpiratory flow rate between 25% and 75% of FVC (FEF
25%-75%). Safety was evaluated by adverse events, physical examinations, vital signs, and laboratory tests.
Baseline characteristics were comparable among treatment groups. Percentage of predicted FEV
1 at baseline was 76.6 ± 6.9 for placebo, 77.5 ± 7.1, and 77.0 ± 7.8 for the budesonide Turbuhaler 200 μg and 400 μg groups, respectively. Significantly (
P ≤ 0.024) more placebo patients (24%) discontinued treatment because of disease deterioration or no improvement than budesonide Turbuhaler 200 μg (11%) or 400 μg patients (10%). Patients receiving budesonide Turbuhaler experienced significant improvements in FEV
1 compared with patients receiving placebo (
P ≤ 0.015). Significant (
P ≤ 0.041) improvements over placebo also were observed in
am and
pm PEFRs, FVC, FEF
25%-75%, nighttime and daytime asthma symptoms, and amount of β
2-agonist used in both budesonide Turbuhaler groups. Adverse events were generally mild or moderate in intensity and similar among treatment groups.
Once-daily budesonide Turbuhaler is effective and safe in children with persistent asthma previously maintained on at least twice-daily dosing regimens of inhaled corticosteroids.</abstract><cop>McLean, VA</cop><pub>Elsevier Inc</pub><pmid>11428735</pmid><doi>10.1016/S1081-1206(10)62291-0</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1081-1206 |
| ispartof | Annals of allergy, asthma, & immunology, 2001-06, Vol.86 (6), p.633-640 |
| issn | 1081-1206 1534-4436 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_70962637 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Administration, Inhalation Adolescent Adult Aged Anti-Inflammatory Agents - administration & dosage Anti-Inflammatory Agents - therapeutic use Biological and medical sciences Budesonide - administration & dosage Budesonide - therapeutic use Drug Administration Schedule Female Forced Expiratory Volume Humans Male Medical sciences Middle Aged Peak Expiratory Flow Rate Pharmacology. Drug treatments Respiratory system |
| title | Once-daily budesonide inhalation powder (Pulmicort Turbuhaler) maintains pulmonary function and symptoms of asthmatic children previously receiving inhaled corticosteroids |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-23T17%3A12%3A13IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Once-daily%20budesonide%20inhalation%20powder%20(Pulmicort%20Turbuhaler)%20maintains%20pulmonary%20function%20and%20symptoms%20of%20asthmatic%20children%20previously%20receiving%20inhaled%20corticosteroids&rft.jtitle=Annals%20of%20allergy,%20asthma,%20&%20immunology&rft.au=Shapiro,%20Gail%20G.&rft.date=2001-06-01&rft.volume=86&rft.issue=6&rft.spage=633&rft.epage=640&rft.pages=633-640&rft.issn=1081-1206&rft.eissn=1534-4436&rft.coden=ANAEA3&rft_id=info:doi/10.1016/S1081-1206(10)62291-0&rft_dat=%3Cproquest_cross%3E74810124%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=202783528&rft_id=info:pmid/11428735&rft_els_id=S1081120610622910&rfr_iscdi=true |