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.
abstract: OBJECTIVE
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pharmacy Practice, Faculty of Pharmacy, Sri Ramachandra University, Porur, Chennai, Tamil Nadu, India.
authors.forename: Muhasaparur Ganesan
authors.initials: MG
authors.lastname: Rajanandh
authors.affiliation: Department of Pulmonary Medicine, SRM Medical College Hospital and Research Centre, SRM University, Tamil Nadu, India.
authors.forename: Arcot D
authors.initials: AD
authors.lastname: Nageswari
authors.affiliation: Interdisciplinary School of Indian System of Medicine, SRM University, Tamil Nadu, India. Electronic address: ilangok67@gmail.com.
authors.forename: Kaliappan
authors.initials: K
authors.lastname: Ilango
mesh_terms: D000085:Acetates / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D019819:Budesonide / Q000008:administration & dosage*; D003521:Cyclopropanes; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects / Q000502:physiology; D006801:Humans; D008297:Male; D011804:Quinolines / Q000008:administration & dosage*; D012129:Respiratory Function Tests; D013440:Sulfides; D013806:Theophylline / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000069447:Tiotropium Bromide / Q000008:administration & dosage*
chemical_list: D000085:Acetates; D001993:Bronchodilator Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D019819:Budesonide; D013806:Theophylline; C093875:montelukast; C029797:doxofylline; D000069447:Tiotropium Bromide
keywords: budesonide; doxofylline; formoterol; montelukast, tiotropium