Long-term Efficacy and Safety of Fluticasone Propionate Powder Administered Once or Twice Daily via Inhaler to Patients With Moderate Asthma
To evaluate the efficacy and safety of fluticasone propionate administered as a once-daily or twice-daily regimen over a period of 1 year to patients with moderate asthma. Double-blind, randomized, parallel group, and placebo-controlled phase (12 weeks) and an open-label phase (54 weeks). Multicente...
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creator | ZuWallack, Richard Adelglass, Jeffery Clifford, Dennis P. Duke, Susan P. Wire, Patrick D. Faris, Melissa Harding, Stuart M. |
description | To evaluate the efficacy and safety of fluticasone propionate administered as a once-daily or twice-daily regimen over a period of 1 year to patients with moderate asthma.
Double-blind, randomized, parallel group, and placebo-controlled phase (12 weeks) and an open-label phase (54 weeks).
Multicenter study in an outpatient setting.
Patients (n = 253; age,≥ 12 years) with a mean FEV1 of 67% predicted normal were stratified according to baseline therapy of maintenance inhaled corticosteroids vs β2-agonists alone.
Fluticasone propionate (250μ g bid or 500 μg qd) or placebo (bid) was administered via the Diskus multidose powder inhaler (Glaxo Wellcome; Research Triangle Park, NC) for 12 weeks. During open-label treatment, patients were re-randomized to once-daily or twice-daily fluticasone propionate.
Compared to placebo, fluticasone propionate administered qd or bid significantly improved FEV1 (p < 0.001), morning (p < 0.001) and evening peak expiratory flow (PEF; p < 0.001), asthma symptom scores (p ≤ 0.001), and albuterol use (p ≤ 0.001), and decreased nighttime awakenings. By the end of 12 weeks, withdrawal due to lack of efficacy was significantly higher in the placebo group than in the once-daily (p = 0.001) or twice-daily (p < 0.001) groups. When comparing the two active dosing regimens, significant differences in favor of twice-daily dosing were noted in FEV1, albuterol use, and withdrawal due to lack of efficacy. During 54 weeks of open-label treatment, FEV1 and PEF continued to improve with both regimens, and improvements seen in the first 12 weeks were maintained in patients who switched from twice-daily to once-daily dosing. Fluticasone propionate treatment over a 54-week period was well tolerated, with few drug-related adverse events, which were primarily topical effects of inhaled corticosteroids.
Fluticasone propionate powder improved lung function when administered either qd or bid over a 1-year period to patients with moderate asthma, with twice-daily dosing demonstrating significantly greater improvement in some efficacy parameters than once-daily dosing over the first 12 weeks of treatment. Fluticasone propionate treatment was not associated with significant systemic effects. |
doi_str_mv | 10.1378/chest.118.2.303 |
format | Article |
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Double-blind, randomized, parallel group, and placebo-controlled phase (12 weeks) and an open-label phase (54 weeks).
Multicenter study in an outpatient setting.
Patients (n = 253; age,≥ 12 years) with a mean FEV1 of 67% predicted normal were stratified according to baseline therapy of maintenance inhaled corticosteroids vs β2-agonists alone.
Fluticasone propionate (250μ g bid or 500 μg qd) or placebo (bid) was administered via the Diskus multidose powder inhaler (Glaxo Wellcome; Research Triangle Park, NC) for 12 weeks. During open-label treatment, patients were re-randomized to once-daily or twice-daily fluticasone propionate.
Compared to placebo, fluticasone propionate administered qd or bid significantly improved FEV1 (p < 0.001), morning (p < 0.001) and evening peak expiratory flow (PEF; p < 0.001), asthma symptom scores (p ≤ 0.001), and albuterol use (p ≤ 0.001), and decreased nighttime awakenings. By the end of 12 weeks, withdrawal due to lack of efficacy was significantly higher in the placebo group than in the once-daily (p = 0.001) or twice-daily (p < 0.001) groups. When comparing the two active dosing regimens, significant differences in favor of twice-daily dosing were noted in FEV1, albuterol use, and withdrawal due to lack of efficacy. During 54 weeks of open-label treatment, FEV1 and PEF continued to improve with both regimens, and improvements seen in the first 12 weeks were maintained in patients who switched from twice-daily to once-daily dosing. Fluticasone propionate treatment over a 54-week period was well tolerated, with few drug-related adverse events, which were primarily topical effects of inhaled corticosteroids.
Fluticasone propionate powder improved lung function when administered either qd or bid over a 1-year period to patients with moderate asthma, with twice-daily dosing demonstrating significantly greater improvement in some efficacy parameters than once-daily dosing over the first 12 weeks of treatment. Fluticasone propionate treatment was not associated with significant systemic effects.</description><identifier>ISSN: 0012-3692</identifier><identifier>EISSN: 1931-3543</identifier><identifier>DOI: 10.1378/chest.118.2.303</identifier><identifier>PMID: 10936117</identifier><identifier>CODEN: CHETBF</identifier><language>eng</language><publisher>Northbrook, IL: Elsevier Inc</publisher><subject>Administration, Inhalation ; Adolescent ; Adrenergic beta-Agonists - administration & dosage ; Adult ; Aged ; Albuterol - administration & dosage ; Androstadienes - administration & dosage ; Anti-Asthmatic Agents - administration & dosage ; asthma ; Asthma - drug therapy ; Asthma - physiopathology ; Biological and medical sciences ; Child ; Circadian Rhythm ; Diskus ; Double-Blind Method ; Drug Administration Schedule ; Female ; Fluticasone ; fluticasone propionate ; Follow-Up Studies ; Forced Expiratory Volume - drug effects ; Humans ; long-term ; Male ; Medical sciences ; Middle Aged ; Nebulizers and Vaporizers ; once-daily ; Pharmacology. Drug treatments ; Powders ; Respiratory system ; Safety ; Severity of Illness Index ; twice-daily</subject><ispartof>Chest, 2000-08, Vol.118 (2), p.303-312</ispartof><rights>2000 The American College of Chest Physicians</rights><rights>2000 INIST-CNRS</rights><rights>Copyright American College of Chest Physicians Aug 2000</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c439t-10d503dedf22e077d2af85f2416ed1a61d9986e9e4fae1f675881a7ccd95ce113</citedby><cites>FETCH-LOGICAL-c439t-10d503dedf22e077d2af85f2416ed1a61d9986e9e4fae1f675881a7ccd95ce113</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1454134$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/10936117$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>ZuWallack, Richard</creatorcontrib><creatorcontrib>Adelglass, Jeffery</creatorcontrib><creatorcontrib>Clifford, Dennis P.</creatorcontrib><creatorcontrib>Duke, Susan P.</creatorcontrib><creatorcontrib>Wire, Patrick D.</creatorcontrib><creatorcontrib>Faris, Melissa</creatorcontrib><creatorcontrib>Harding, Stuart M.</creatorcontrib><title>Long-term Efficacy and Safety of Fluticasone Propionate Powder Administered Once or Twice Daily via Inhaler to Patients With Moderate Asthma</title><title>Chest</title><addtitle>Chest</addtitle><description>To evaluate the efficacy and safety of fluticasone propionate administered as a once-daily or twice-daily regimen over a period of 1 year to patients with moderate asthma.
Double-blind, randomized, parallel group, and placebo-controlled phase (12 weeks) and an open-label phase (54 weeks).
Multicenter study in an outpatient setting.
Patients (n = 253; age,≥ 12 years) with a mean FEV1 of 67% predicted normal were stratified according to baseline therapy of maintenance inhaled corticosteroids vs β2-agonists alone.
Fluticasone propionate (250μ g bid or 500 μg qd) or placebo (bid) was administered via the Diskus multidose powder inhaler (Glaxo Wellcome; Research Triangle Park, NC) for 12 weeks. During open-label treatment, patients were re-randomized to once-daily or twice-daily fluticasone propionate.
Compared to placebo, fluticasone propionate administered qd or bid significantly improved FEV1 (p < 0.001), morning (p < 0.001) and evening peak expiratory flow (PEF; p < 0.001), asthma symptom scores (p ≤ 0.001), and albuterol use (p ≤ 0.001), and decreased nighttime awakenings. By the end of 12 weeks, withdrawal due to lack of efficacy was significantly higher in the placebo group than in the once-daily (p = 0.001) or twice-daily (p < 0.001) groups. When comparing the two active dosing regimens, significant differences in favor of twice-daily dosing were noted in FEV1, albuterol use, and withdrawal due to lack of efficacy. During 54 weeks of open-label treatment, FEV1 and PEF continued to improve with both regimens, and improvements seen in the first 12 weeks were maintained in patients who switched from twice-daily to once-daily dosing. Fluticasone propionate treatment over a 54-week period was well tolerated, with few drug-related adverse events, which were primarily topical effects of inhaled corticosteroids.
Fluticasone propionate powder improved lung function when administered either qd or bid over a 1-year period to patients with moderate asthma, with twice-daily dosing demonstrating significantly greater improvement in some efficacy parameters than once-daily dosing over the first 12 weeks of treatment. Fluticasone propionate treatment was not associated with significant systemic effects.</description><subject>Administration, Inhalation</subject><subject>Adolescent</subject><subject>Adrenergic beta-Agonists - administration & dosage</subject><subject>Adult</subject><subject>Aged</subject><subject>Albuterol - administration & dosage</subject><subject>Androstadienes - administration & dosage</subject><subject>Anti-Asthmatic Agents - administration & dosage</subject><subject>asthma</subject><subject>Asthma - drug therapy</subject><subject>Asthma - physiopathology</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Circadian Rhythm</subject><subject>Diskus</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Fluticasone</subject><subject>fluticasone propionate</subject><subject>Follow-Up Studies</subject><subject>Forced Expiratory Volume - drug effects</subject><subject>Humans</subject><subject>long-term</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nebulizers and Vaporizers</subject><subject>once-daily</subject><subject>Pharmacology. Drug treatments</subject><subject>Powders</subject><subject>Respiratory system</subject><subject>Safety</subject><subject>Severity of Illness Index</subject><subject>twice-daily</subject><issn>0012-3692</issn><issn>1931-3543</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2000</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kdFrFDEQxhdRbK0--yZBxLe9ZpLdze7jUVstnLRgxccQk0k3ZTc5k1yP-x_8o029gxbBp0yG33zfMF9VvQW6AC76Uz1iyguAfsEWnPJn1TEMHGreNvx5dUwpsJp3AzuqXqV0R8sfhu5ldQR04B2AOK5-r4K_rTPGmZxb67TSO6K8Id-UxbwjwZKLaZNLPwWP5DqGtQte5VKGrcFIlmZ23qUigIZceY0kRHKzdaX4pNy0I_dOkUs_qqnAOZBrlR36nMgPl0fyNRSNB7VlyuOsXlcvrJoSvjm8J9X3i_Obsy_16urz5dlyVeuGD7kGalrKDRrLGFIhDFO2by1roEMDqgMzDH2HAzZWIdhOtH0PSmhthlYjAD-pPu511zH82pQLytkljdOkPIZNkgJERwXrCvj-H_AubKIvu0lGadOyRogCne4hHUNKEa1cRzeruJNA5UNK8m9KsqQkmSwplYl3B9nNzxnNE34fSwE-HACVtJpsVF679Mg1bQO8eXQe3e24dRFlmtU0FVW-9zxs-9R52E9gOe-9wyiTLnloNGVaZ2mC--_WfwAsPcC2</recordid><startdate>20000801</startdate><enddate>20000801</enddate><creator>ZuWallack, Richard</creator><creator>Adelglass, Jeffery</creator><creator>Clifford, Dennis P.</creator><creator>Duke, Susan P.</creator><creator>Wire, Patrick D.</creator><creator>Faris, Melissa</creator><creator>Harding, Stuart M.</creator><general>Elsevier Inc</general><general>American College of Chest Physicians</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>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope></search><sort><creationdate>20000801</creationdate><title>Long-term Efficacy and Safety of Fluticasone Propionate Powder Administered Once or Twice Daily via Inhaler to Patients With Moderate Asthma</title><author>ZuWallack, Richard ; Adelglass, Jeffery ; Clifford, Dennis P. ; Duke, Susan P. ; Wire, Patrick D. ; Faris, Melissa ; Harding, Stuart M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c439t-10d503dedf22e077d2af85f2416ed1a61d9986e9e4fae1f675881a7ccd95ce113</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2000</creationdate><topic>Administration, Inhalation</topic><topic>Adolescent</topic><topic>Adrenergic beta-Agonists - administration & dosage</topic><topic>Adult</topic><topic>Aged</topic><topic>Albuterol - administration & dosage</topic><topic>Androstadienes - administration & dosage</topic><topic>Anti-Asthmatic Agents - administration & dosage</topic><topic>asthma</topic><topic>Asthma - drug therapy</topic><topic>Asthma - physiopathology</topic><topic>Biological and medical sciences</topic><topic>Child</topic><topic>Circadian Rhythm</topic><topic>Diskus</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Fluticasone</topic><topic>fluticasone propionate</topic><topic>Follow-Up Studies</topic><topic>Forced Expiratory Volume - drug effects</topic><topic>Humans</topic><topic>long-term</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nebulizers and Vaporizers</topic><topic>once-daily</topic><topic>Pharmacology. Drug treatments</topic><topic>Powders</topic><topic>Respiratory system</topic><topic>Safety</topic><topic>Severity of Illness Index</topic><topic>twice-daily</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>ZuWallack, Richard</creatorcontrib><creatorcontrib>Adelglass, Jeffery</creatorcontrib><creatorcontrib>Clifford, Dennis P.</creatorcontrib><creatorcontrib>Duke, Susan P.</creatorcontrib><creatorcontrib>Wire, Patrick D.</creatorcontrib><creatorcontrib>Faris, Melissa</creatorcontrib><creatorcontrib>Harding, Stuart M.</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 Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><jtitle>Chest</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>ZuWallack, Richard</au><au>Adelglass, Jeffery</au><au>Clifford, Dennis P.</au><au>Duke, Susan P.</au><au>Wire, Patrick D.</au><au>Faris, Melissa</au><au>Harding, Stuart M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term Efficacy and Safety of Fluticasone Propionate Powder Administered Once or Twice Daily via Inhaler to Patients With Moderate Asthma</atitle><jtitle>Chest</jtitle><addtitle>Chest</addtitle><date>2000-08-01</date><risdate>2000</risdate><volume>118</volume><issue>2</issue><spage>303</spage><epage>312</epage><pages>303-312</pages><issn>0012-3692</issn><eissn>1931-3543</eissn><coden>CHETBF</coden><abstract>To evaluate the efficacy and safety of fluticasone propionate administered as a once-daily or twice-daily regimen over a period of 1 year to patients with moderate asthma.
Double-blind, randomized, parallel group, and placebo-controlled phase (12 weeks) and an open-label phase (54 weeks).
Multicenter study in an outpatient setting.
Patients (n = 253; age,≥ 12 years) with a mean FEV1 of 67% predicted normal were stratified according to baseline therapy of maintenance inhaled corticosteroids vs β2-agonists alone.
Fluticasone propionate (250μ g bid or 500 μg qd) or placebo (bid) was administered via the Diskus multidose powder inhaler (Glaxo Wellcome; Research Triangle Park, NC) for 12 weeks. During open-label treatment, patients were re-randomized to once-daily or twice-daily fluticasone propionate.
Compared to placebo, fluticasone propionate administered qd or bid significantly improved FEV1 (p < 0.001), morning (p < 0.001) and evening peak expiratory flow (PEF; p < 0.001), asthma symptom scores (p ≤ 0.001), and albuterol use (p ≤ 0.001), and decreased nighttime awakenings. By the end of 12 weeks, withdrawal due to lack of efficacy was significantly higher in the placebo group than in the once-daily (p = 0.001) or twice-daily (p < 0.001) groups. When comparing the two active dosing regimens, significant differences in favor of twice-daily dosing were noted in FEV1, albuterol use, and withdrawal due to lack of efficacy. During 54 weeks of open-label treatment, FEV1 and PEF continued to improve with both regimens, and improvements seen in the first 12 weeks were maintained in patients who switched from twice-daily to once-daily dosing. Fluticasone propionate treatment over a 54-week period was well tolerated, with few drug-related adverse events, which were primarily topical effects of inhaled corticosteroids.
Fluticasone propionate powder improved lung function when administered either qd or bid over a 1-year period to patients with moderate asthma, with twice-daily dosing demonstrating significantly greater improvement in some efficacy parameters than once-daily dosing over the first 12 weeks of treatment. Fluticasone propionate treatment was not associated with significant systemic effects.</abstract><cop>Northbrook, IL</cop><pub>Elsevier Inc</pub><pmid>10936117</pmid><doi>10.1378/chest.118.2.303</doi><tpages>10</tpages></addata></record> |
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subjects | Administration, Inhalation Adolescent Adrenergic beta-Agonists - administration & dosage Adult Aged Albuterol - administration & dosage Androstadienes - administration & dosage Anti-Asthmatic Agents - administration & dosage asthma Asthma - drug therapy Asthma - physiopathology Biological and medical sciences Child Circadian Rhythm Diskus Double-Blind Method Drug Administration Schedule Female Fluticasone fluticasone propionate Follow-Up Studies Forced Expiratory Volume - drug effects Humans long-term Male Medical sciences Middle Aged Nebulizers and Vaporizers once-daily Pharmacology. Drug treatments Powders Respiratory system Safety Severity of Illness Index twice-daily |
title | Long-term Efficacy and Safety of Fluticasone Propionate Powder Administered Once or Twice Daily via Inhaler to Patients With Moderate Asthma |
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