Assessment of Montelukast, Doxofylline, and Tiotropium With Budesonide for the Treatment of Asthma: Which Is the Best Among the Second-line Treatment? A Randomized Trial
Abstract Purpose Data comparing various second-line treatments for asthma with subjective and objective assessment are lacking. This study aimed to compare the efficacy and safety of montelukast, doxofylline, and tiotropium with a low-dose budesonide in patients with mild to moderate persistent asth...
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| Veröffentlicht in: | Clinical therapeutics 2015-02, Vol.37 (2), p.418-426 |
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| creator | Rajanandh, Muhasaparur Ganesan, MPharm, PhD Nageswari, Arcot D., MD, DTCD, FCCP, DTCE Ilango, Kaliappan, MPharm, PhD, FIC |
| description | Abstract Purpose Data comparing various second-line treatments for asthma with subjective and objective assessment are lacking. This study aimed to compare the efficacy and safety of montelukast, doxofylline, and tiotropium with a low-dose budesonide in patients with mild to moderate persistent asthma. Methods Patients, all of whom were concurrently using inhaled budesonide (400 µg), were treated for 6 months with formoterol (12 µg), montelukast (10 mg), doxofylline (400 mg), or tiotropium (18 µg). Outcomes included forced expiratory volume in 1 second (FEV1 ), Saint George Respiratory Questionnaire (SGRQ) scores, asthma symptom scores (daytime and nighttime), and assessment of tolerability and rescue medication use. Findings A total of 297 patients completed the study. In all 4 groups, significant improvements were observed in all the outcome measures, with formoterol treatment having greater and earlier improvements than the other 3 second-line controller medications with budesonide. Among the second-line treatments, monteradlukast improved the FEV1 from day 45 ( P < 0.01), SGRQ scores from day 30 ( P < 0.0001), daytime scores from day 30 ( P < 0.05), nighttime scores from day 30 ( P < 0.0001), and rescue medication use from day 15 ( P < .0001) at a faster rate than doxofylline or tiotropium with budesonide. No patients discontinued the treatment because of adverse reactions. Implications Among the tested second-line treatment regimens, the budesonide/montelukast combination was found to be superior to either the budesonide/doxofylline or budesonide/tiotropium combination in all the outcome measures without adversely affecting the tolerability of the patients. Further clinical studies with blinding techniques are likely to be useful. |
| doi_str_mv | 10.1016/j.clinthera.2014.12.008 |
| format | Article |
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A Randomized Trial</title><source>MEDLINE</source><source>Access via ScienceDirect (Elsevier)</source><source>ProQuest Central UK/Ireland</source><creator>Rajanandh, Muhasaparur Ganesan, MPharm, PhD ; Nageswari, Arcot D., MD, DTCD, FCCP, DTCE ; Ilango, Kaliappan, MPharm, PhD, FIC</creator><creatorcontrib>Rajanandh, Muhasaparur Ganesan, MPharm, PhD ; Nageswari, Arcot D., MD, DTCD, FCCP, DTCE ; Ilango, Kaliappan, MPharm, PhD, FIC</creatorcontrib><description>Abstract Purpose Data comparing various second-line treatments for asthma with subjective and objective assessment are lacking. This study aimed to compare the efficacy and safety of montelukast, doxofylline, and tiotropium with a low-dose budesonide in patients with mild to moderate persistent asthma. Methods Patients, all of whom were concurrently using inhaled budesonide (400 µg), were treated for 6 months with formoterol (12 µg), montelukast (10 mg), doxofylline (400 mg), or tiotropium (18 µg). Outcomes included forced expiratory volume in 1 second (FEV1 ), Saint George Respiratory Questionnaire (SGRQ) scores, asthma symptom scores (daytime and nighttime), and assessment of tolerability and rescue medication use. Findings A total of 297 patients completed the study. In all 4 groups, significant improvements were observed in all the outcome measures, with formoterol treatment having greater and earlier improvements than the other 3 second-line controller medications with budesonide. Among the second-line treatments, monteradlukast improved the FEV1 from day 45 ( P < 0.01), SGRQ scores from day 30 ( P < 0.0001), daytime scores from day 30 ( P < 0.05), nighttime scores from day 30 ( P < 0.0001), and rescue medication use from day 15 ( P < .0001) at a faster rate than doxofylline or tiotropium with budesonide. No patients discontinued the treatment because of adverse reactions. Implications Among the tested second-line treatment regimens, the budesonide/montelukast combination was found to be superior to either the budesonide/doxofylline or budesonide/tiotropium combination in all the outcome measures without adversely affecting the tolerability of the patients. Further clinical studies with blinding techniques are likely to be useful.</description><identifier>ISSN: 0149-2918</identifier><identifier>EISSN: 1879-114X</identifier><identifier>DOI: 10.1016/j.clinthera.2014.12.008</identifier><identifier>PMID: 25577543</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject><![CDATA[Acetates - administration & dosage ; Adolescent ; Adult ; Age ; Asthma ; Asthma - drug therapy ; Bronchodilator Agents - administration & dosage ; budesonide ; Budesonide - administration & dosage ; doxofylline ; Drug Therapy, Combination - methods ; Female ; Forced Expiratory Volume - drug effects ; Forced Expiratory Volume - physiology ; formoterol ; Humans ; Internal Medicine ; Literacy ; Male ; Medical Education ; montelukast, tiotropium ; Quality of life ; Questionnaires ; Quinolines - administration & dosage ; Respiratory Function Tests ; Software ; Theophylline - administration & dosage ; Theophylline - analogs & derivatives ; Tiotropium Bromide - administration & dosage]]></subject><ispartof>Clinical therapeutics, 2015-02, Vol.37 (2), p.418-426</ispartof><rights>Elsevier HS Journals, Inc.</rights><rights>2015 Elsevier HS Journals, Inc.</rights><rights>Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited Feb 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c454t-9204d845081103e39cfa2244ef90a8d1ba7bc9980e047a11fce07f60d0b69183</citedby><cites>FETCH-LOGICAL-c454t-9204d845081103e39cfa2244ef90a8d1ba7bc9980e047a11fce07f60d0b69183</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1717542632?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>315,781,785,3551,27926,27927,45997,64387,64389,64391,72471</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25577543$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rajanandh, Muhasaparur Ganesan, MPharm, PhD</creatorcontrib><creatorcontrib>Nageswari, Arcot D., MD, DTCD, FCCP, DTCE</creatorcontrib><creatorcontrib>Ilango, Kaliappan, MPharm, PhD, FIC</creatorcontrib><title>Assessment of Montelukast, Doxofylline, and Tiotropium With Budesonide for the Treatment of Asthma: Which Is the Best Among the Second-line Treatment? A Randomized Trial</title><title>Clinical therapeutics</title><addtitle>Clin Ther</addtitle><description>Abstract Purpose Data comparing various second-line treatments for asthma with subjective and objective assessment are lacking. This study aimed to compare the efficacy and safety of montelukast, doxofylline, and tiotropium with a low-dose budesonide in patients with mild to moderate persistent asthma. Methods Patients, all of whom were concurrently using inhaled budesonide (400 µg), were treated for 6 months with formoterol (12 µg), montelukast (10 mg), doxofylline (400 mg), or tiotropium (18 µg). Outcomes included forced expiratory volume in 1 second (FEV1 ), Saint George Respiratory Questionnaire (SGRQ) scores, asthma symptom scores (daytime and nighttime), and assessment of tolerability and rescue medication use. Findings A total of 297 patients completed the study. In all 4 groups, significant improvements were observed in all the outcome measures, with formoterol treatment having greater and earlier improvements than the other 3 second-line controller medications with budesonide. Among the second-line treatments, monteradlukast improved the FEV1 from day 45 ( P < 0.01), SGRQ scores from day 30 ( P < 0.0001), daytime scores from day 30 ( P < 0.05), nighttime scores from day 30 ( P < 0.0001), and rescue medication use from day 15 ( P < .0001) at a faster rate than doxofylline or tiotropium with budesonide. No patients discontinued the treatment because of adverse reactions. Implications Among the tested second-line treatment regimens, the budesonide/montelukast combination was found to be superior to either the budesonide/doxofylline or budesonide/tiotropium combination in all the outcome measures without adversely affecting the tolerability of the patients. Further clinical studies with blinding techniques are likely to be useful.</description><subject>Acetates - administration & dosage</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Age</subject><subject>Asthma</subject><subject>Asthma - drug therapy</subject><subject>Bronchodilator Agents - administration & dosage</subject><subject>budesonide</subject><subject>Budesonide - administration & dosage</subject><subject>doxofylline</subject><subject>Drug Therapy, Combination - methods</subject><subject>Female</subject><subject>Forced Expiratory Volume - drug effects</subject><subject>Forced Expiratory Volume - physiology</subject><subject>formoterol</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Literacy</subject><subject>Male</subject><subject>Medical Education</subject><subject>montelukast, tiotropium</subject><subject>Quality of life</subject><subject>Questionnaires</subject><subject>Quinolines - administration & dosage</subject><subject>Respiratory Function Tests</subject><subject>Software</subject><subject>Theophylline - administration & dosage</subject><subject>Theophylline - analogs & derivatives</subject><subject>Tiotropium Bromide - administration & dosage</subject><issn>0149-2918</issn><issn>1879-114X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqNkttu1DAQhi0EokvhFcASN1w0weM4Jy5AaTlVKkKiK5U7y-tMWG-TeLEdxPJGvCVOtwepV1xZlr9__vH8Q8gLYCkwKF5vUt2bMazRqZQzECnwlLHqAVlAVdYJgPj-kCziQ53wGqoD8sT7DWMsq3P-mBzwPC_LXGQL8rfxHr0fcAzUdvSLHQP206Xy4Yi-t79tt-ujER5RNbZ0aWxwdmumgV6YsKbHU4vejqZF2llHYzt06VCFm2qND-tBvaEXa6PX9NRfEcfoA20GO_64up6jtmObzCZ34ne0od-iox3MH4y-zqj-KXnUqd7js-vzkCw_fliefE7Ovn46PWnOEi1yEZKaM9FWImcVAMswq3WnOBcCu5qpqoWVKle6riuGTJQKoNPIyq5gLVsVcVLZIXm1L7t19ucUe5WD8Rr7Xo1oJy-hKJgAXpd5RF_eQzd2cmNsTkIJcb68yHikyj2lnfXeYSe3zgzK7SQwOYcpN_I2TDmHKYHLGGZUPr-uP60GbG91N-lFoNkDGOfxy6CTXhscNbbGoQ6yteY_TN7eqzFzRqv-Enfo734kfRTI83mn5pUCEdW8yrN_Z-rKMw</recordid><startdate>20150201</startdate><enddate>20150201</enddate><creator>Rajanandh, Muhasaparur Ganesan, MPharm, PhD</creator><creator>Nageswari, Arcot D., MD, DTCD, FCCP, DTCE</creator><creator>Ilango, Kaliappan, MPharm, PhD, FIC</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><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>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20150201</creationdate><title>Assessment of Montelukast, Doxofylline, and Tiotropium With Budesonide for the Treatment of Asthma: Which Is the Best Among the Second-line Treatment? A Randomized Trial</title><author>Rajanandh, Muhasaparur Ganesan, MPharm, PhD ; Nageswari, Arcot D., MD, DTCD, FCCP, DTCE ; Ilango, Kaliappan, MPharm, PhD, FIC</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c454t-9204d845081103e39cfa2244ef90a8d1ba7bc9980e047a11fce07f60d0b69183</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Acetates - administration & dosage</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Age</topic><topic>Asthma</topic><topic>Asthma - drug therapy</topic><topic>Bronchodilator Agents - administration & dosage</topic><topic>budesonide</topic><topic>Budesonide - administration & dosage</topic><topic>doxofylline</topic><topic>Drug Therapy, Combination - methods</topic><topic>Female</topic><topic>Forced Expiratory Volume - drug effects</topic><topic>Forced Expiratory Volume - physiology</topic><topic>formoterol</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Literacy</topic><topic>Male</topic><topic>Medical Education</topic><topic>montelukast, tiotropium</topic><topic>Quality of life</topic><topic>Questionnaires</topic><topic>Quinolines - administration & dosage</topic><topic>Respiratory Function Tests</topic><topic>Software</topic><topic>Theophylline - administration & dosage</topic><topic>Theophylline - analogs & derivatives</topic><topic>Tiotropium Bromide - administration & dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rajanandh, Muhasaparur Ganesan, MPharm, PhD</creatorcontrib><creatorcontrib>Nageswari, Arcot D., MD, DTCD, FCCP, DTCE</creatorcontrib><creatorcontrib>Ilango, Kaliappan, MPharm, PhD, FIC</creatorcontrib><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>ProQuest Nursing and Allied Health Source</collection><collection>Health & Medical Collection (Proquest)</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>ProQuest Health Management</collection><collection>PML(ProQuest Medical Library)</collection><collection>ProQuest Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Research Library (Corporate)</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>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rajanandh, Muhasaparur Ganesan, MPharm, PhD</au><au>Nageswari, Arcot D., MD, DTCD, FCCP, DTCE</au><au>Ilango, Kaliappan, MPharm, PhD, FIC</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Assessment of Montelukast, Doxofylline, and Tiotropium With Budesonide for the Treatment of Asthma: Which Is the Best Among the Second-line Treatment? A Randomized Trial</atitle><jtitle>Clinical therapeutics</jtitle><addtitle>Clin Ther</addtitle><date>2015-02-01</date><risdate>2015</risdate><volume>37</volume><issue>2</issue><spage>418</spage><epage>426</epage><pages>418-426</pages><issn>0149-2918</issn><eissn>1879-114X</eissn><abstract>Abstract Purpose Data comparing various second-line treatments for asthma with subjective and objective assessment are lacking. This study aimed to compare the efficacy and safety of montelukast, doxofylline, and tiotropium with a low-dose budesonide in patients with mild to moderate persistent asthma. Methods Patients, all of whom were concurrently using inhaled budesonide (400 µg), were treated for 6 months with formoterol (12 µg), montelukast (10 mg), doxofylline (400 mg), or tiotropium (18 µg). Outcomes included forced expiratory volume in 1 second (FEV1 ), Saint George Respiratory Questionnaire (SGRQ) scores, asthma symptom scores (daytime and nighttime), and assessment of tolerability and rescue medication use. Findings A total of 297 patients completed the study. In all 4 groups, significant improvements were observed in all the outcome measures, with formoterol treatment having greater and earlier improvements than the other 3 second-line controller medications with budesonide. Among the second-line treatments, monteradlukast improved the FEV1 from day 45 ( P < 0.01), SGRQ scores from day 30 ( P < 0.0001), daytime scores from day 30 ( P < 0.05), nighttime scores from day 30 ( P < 0.0001), and rescue medication use from day 15 ( P < .0001) at a faster rate than doxofylline or tiotropium with budesonide. No patients discontinued the treatment because of adverse reactions. Implications Among the tested second-line treatment regimens, the budesonide/montelukast combination was found to be superior to either the budesonide/doxofylline or budesonide/tiotropium combination in all the outcome measures without adversely affecting the tolerability of the patients. Further clinical studies with blinding techniques are likely to be useful.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>25577543</pmid><doi>10.1016/j.clinthera.2014.12.008</doi><tpages>9</tpages></addata></record> |
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| subjects | Acetates - administration & dosage Adolescent Adult Age Asthma Asthma - drug therapy Bronchodilator Agents - administration & dosage budesonide Budesonide - administration & dosage doxofylline Drug Therapy, Combination - methods Female Forced Expiratory Volume - drug effects Forced Expiratory Volume - physiology formoterol Humans Internal Medicine Literacy Male Medical Education montelukast, tiotropium Quality of life Questionnaires Quinolines - administration & dosage Respiratory Function Tests Software Theophylline - administration & dosage Theophylline - analogs & derivatives Tiotropium Bromide - administration & dosage |
| title | Assessment of Montelukast, Doxofylline, and Tiotropium With Budesonide for the Treatment of Asthma: Which Is the Best Among the Second-line Treatment? A Randomized Trial |
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