title: Pulmonary function assessment in mild to moderate persistent asthma patients receiving montelukast, doxofylline, and tiotropium with budesonide: a randomized controlled study.
abstract: BACKGROUND
  There is no comparative study among asthma patients receiving first-line versus various second-line treatment regimens for mild to moderate persistent asthma.
  
  
  OBJECTIVE
  We assessed the pulmonary function in asthma patients receiving montelukast, doxofylline, and tiotropium with budesonide in a pilot group.
  
  
  METHODS
  Patients were recruited as per the study criteria and randomly allocated to 4 groups to receive budesonide (400 µg) with formoterol (12 µg), doxofylline (400 mg), montelukast (10 mg), or tiotropium (18 µg) for a period of 3 months. Outcomes included forced expiratory volume in 1 second (FEV1) and rescue medication use.
  
  
  RESULTS
  A total of 167 patients were recruited; among them, 123 patients completed the study. At baseline, no significant difference (P > 0.05) was observed in any of the outcome measures. Significant within-group improvement in FEV1 was observed in all the groups. At day 90, between-group difference revealed that improvement in FEV1 was significantly (P < 0.05) high for budesonide plus formoterol followed by budesonide plus doxofylline, budesonide plus montelukast, and, lastly, budesonide plus tiotropium. Similarly, within-group comparison revealed a significant (P < 0.05) reduction in rescue medication use in all the groups. The intensity in decrease was more in budesonide plus formoterol group followed by budesonide plus doxofylline, budesonide plus montelukast, and budesonide plus tiotropium groups.
  
  
  CONCLUSIONS
  On the basis of our findings, among the second-line treatment regimens, budesonide plus doxofylline and budesonide plus montelukast was found to be better than budesonide plus tiotropium in patients with mild to moderate persistent asthma. Further studies with a larger sample size are likely to be useful.
authors.affiliation: Department of Pharmacy Practice, SRM College of Pharmacy, Tamil Nadu, India.
authors.forename: Muhasaparur G
authors.initials: MG
authors.lastname: Rajanandh
authors.affiliation: Department of Pulmonary Medicine, SRM Medical College Hospital and Research Centre, 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 / Q000627:therapeutic use; D000328:Adult; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D019819:Budesonide / Q000627:therapeutic use; D003521:Cyclopropanes; D004359:Drug Therapy, Combination; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects / Q000502:physiology; D000068759:Formoterol Fumarate / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D011804:Quinolines / Q000627:therapeutic use; D012129:Respiratory Function Tests; D013440:Sulfides; D013806:Theophylline / Q000031:analogs & derivatives / Q000627:therapeutic use; D000069447:Tiotropium Bromide / Q000627:therapeutic use
chemical_list: D000085:Acetates; D001993:Bronchodilator Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D019819:Budesonide; D013806:Theophylline; C093875:montelukast; C029797:doxofylline; D000068759:Formoterol Fumarate; D000069447:Tiotropium Bromide
keywords: budesonide; doxofylline; formoterol; montelukast; tiotropium