Azithromycin or montelukast as inhaled corticosteroid-sparing agents in moderate-to-severe childhood asthma study
Robert C. Strunk,Leonard B. Bacharier,Brenda R. Phillips,Stanley J. Szefler,Robert S. Zeiger,Robert S. Zeiger,Vernon M. Chinchilli,Fernando D. Martinez,Robert F. Lemanske,Lynn M. Taussig,David T. Mauger,Wayne J. Morgan,Christine A. Sorkness,Ian M. Paul,Theresa W. Guilbert,Marzena E. Krawiec,Ronina A. Covar,Gary L. Larsen +17 more
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Neither azithromycin nor montelukast is likely to be an effective inhaled corticosteroid-sparing alternative in children with moderate-to-severe persistent asthma.Abstract:
Background Clinical trials in children with moderate-to-severe persistent asthma are limited. Objective We sought to determine whether azithromycin or montelukast are inhaled corticosteroid sparing. Methods The budesonide dose (with salmeterol [50 μg] twice daily) necessary to achieve control was determined in children 6 to 17 years of age with moderate-to-severe persistent asthma. After a budesonide-stable period of 6 weeks, children were randomized in a double-masked, parallel, multicenter study to receive once-nightly azithromycin, montelukast, or matching placebos plus the established controlling dose of budesonide (minimum, 400 μg twice daily) and salmeterol twice daily. Primary outcome was time from randomization to inadequate asthma control after sequential budesonide dose reduction. Results Of 292 children screened, only 55 were randomized. Inadequate adherence to study medication (n = 80) and improved asthma control under close medical supervision (n = 49) were the major reasons for randomization failure. A futility analysis was requested by the Data Safety Monitoring Board. In data available for analyses, no differences were noted for either treatment compared with placebo in time to inadequate control status (median: azithromycin, 8.4 weeks [95% confidence limit, 4.3-17.3]; montelukast, 13.9 weeks [95% confidence limit, 4.7-20.6]; placebo, 19.1 weeks [95% confidence limit, 11.7-infinity]), with no difference between the groups (log-rank test, P = .49). The futility analysis indicated that even if the planned sample size was reached, the results of this negative study were unlikely to be different, and the trial was prematurely terminated. Conclusion Based on these results, neither azithromycin nor montelukast is likely to be an effective inhaled corticosteroid–sparing alternative in children with moderate-to-severe persistent asthma.read more
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International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma
Kian Fan Chung,Sally E. Wenzel,Jan Brozek,Andrew Bush,Mario Castro,Peter J. Sterk,Ian M. Adcock,Eric D. Bateman,Elisabeth H. Bel,Eugene R. Bleecker,Louis-Philippe Boulet,Christopher E. Brightling,Pascal Chanez,Sven-Erik Dahlén,Ratko Djukanovic,Urs Frey,Mina Gaga,Peter G. Gibson,Qutayba Hamid,Nizar N. Jajour,Thais Mauad,Ronald L. Sorkness,W. Gerald Teague +22 more
TL;DR: Recommendations and guidelines on the evaluation and treatment of severe asthma in children and adults and coordinated research efforts for improved phenotyping will provide safe and effective biomarker-driven approaches to severe asthma therapy are provided.
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Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations.
Stephen J. Teach,Michelle A. Gill,Alkis Togias,Christine A. Sorkness,Samuel J. Arbes,Agustin Calatroni,Jeremy Wildfire,Peter J. Gergen,Robyn T. Cohen,Jacqueline A. Pongracic,Carolyn M. Kercsmar,Gurjit K. Khurana Hershey,Rebecca S. Gruchalla,Andrew H. Liu,Edward M. Zoratti,Meyer Kattan,Kristine Grindle,James E. Gern,William W. Busse,Stanley J. Szefler +19 more
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Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline
Fernando Holguin,Juan Carlos Cardet,Kian Fan Chung,Sarah Diver,Diogenes S. Ferreira,Diogenes S. Ferreira,Anne M. Fitzpatrick,Mina Gaga,Liz Kellermeyer,Sandhya Khurana,Shandra L Knight,Vanessa M. McDonald,Rebecca L. Morgan,Victor E. Ortega,David Rigau,Padmaja Subbarao,Thomy Tonia,Ian M. Adcock,Eugene R. Bleecker,Christopher E. Brightling,Louis-Philippe Boulet,Michael D. Cabana,Mario Castro,Pascal Chanez,Adnan Custovic,Ratko Djukanovic,Urs Frey,Betty Frankemölle,Peter G. Gibson,Dominique Hamerlijnck,Nizar N. Jarjour,Satoshi Konno,Huahao Shen,Cathy Vitary,Andrew Bush +34 more
TL;DR: Clinical recommendations for the management of severe asthma are provided and the use of novel therapies for severe asthma, specifically biologicals for type 2 high asthma, and antimuscarinic agents and macrolides, as well as on biomarkers for predicting treatment response are made.
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References
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Lisa Saiman,Bruce C. Marshall,Bruce C. Marshall,Nicole Mayer-Hamblett,Jane L. Burns,Alexandra L. Quittner,Debra A. Cibene,Sarah Coquillette,Ann Yunker Fieberg,Frank J. Accurso,Preston W. Campbell +10 more
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Characterization of within-subject responses to fluticasone and montelukast in childhood asthma
Stanley J. Szefler,Brenda R. Phillips,Fernando D. Martinez,Vernon M. Chinchilli,Robert F. Lemanske,Robert C. Strunk,Robert S. Zeiger,Robert S. Zeiger,Gary L. Larsen,Joseph D. Spahn,Leonard B. Bacharier,Gordon R. Bloomberg,Theresa W. Guilbert,Gregory P. Heldt,Wayne J. Morgan,Mark H. Moss,Christine A. Sorkness,Lynn M. Taussig +17 more
TL;DR: Whether responses to ICSs and LTRAs are concordant for individuals or whether asthmatic patients who do not respond to one medication respond to the other is investigated.
Journal ArticleDOI
Inhaled corticosteroid reduction and elimination in patients with persistent asthma receiving salmeterol: A randomized controlled trial
Robert F. Lemanske,Christine A. Sorkness,Elizabeth A. Mauger,Stephen C. Lazarus,Homer A. Boushey,John V. Fahy,Jeffrey M. Drazen,Vernon M. Chinchilli,Timothy J. Craig,James E. Fish,Jean G. Ford,Elliot Israel,Monica Kraft,Richard J. Martin,Sami A. Nachman,Stephen P. Peters,Joseph D. Spahn,Stanley J. Szefler +17 more
TL;DR: The results indicate that in patients with persistent asthma suboptimally controlled by triamcinolone therapy alone but whose asthma symptoms improve after addition of salmeterol, a substantial reduction in triaminolone dose can occur without a significant loss of asthma control.