title: Effects of the addition of nedocromil sodium to maintenance bronchodilator therapy in the management of chronic asthma.
abstract: OBJECTIVE
  To assess the efficacy and safety of nedocromil sodium metered dose aerosol as an adjunct to sustained-released theophylline therapy in adult theophylline-dependent asthma patients and to examine the ability of nedocromil sodium to substitute for theophylline.
  
  
  METHODS
  Randomized double-blind placebo-controlled parallel group study. Two-week baseline, eight-week treatment period.
  
  
  METHODS
  Out-Patient Clinic.
  
  
  METHODS
  Sequential sample of 35 adult chronic asthmatic patients maintained on a regimen of sustained-release theophylline (dose range, 400 to 800 mg daily) and on-demand inhaled beta 2-bronchodilators. All patients completed the study.
  
  
  METHODS
  2 x 2-mg nedocromil sodium metered dose aerosol twice daily or matching placebo randomly allocated after two-week baseline. Theophylline dose reduced by half or one third after four weeks of test treatments, then stopped for final two weeks. Use of inhaled beta 2-bronchodilators permitted throughout trial period.
  
  
  RESULTS
  The following results were in favor (statistically significant findings, p less than 0.05) of nedocromil sodium compared with placebo: all diary card efficacy variables (nighttime asthma, morning tightness, daytime asthma, cough, twice daily peak expiratory flow [PEF], inhaled beta 2 use) during all periods of assessment (weeks 1 to 2, 3 to 4, 5 to 6, and 7 to 8) with the exception of cough and nighttime beta 2 use during weeks 1 to 2; patient and clinician opinion of treatment efficacy (end of weeks 4 and 8); ability to reduce the theophylline dose; clinician assessment of asthma severity at the end of the study, and clinic FEV1 at weeks 4, 5, 6, and 8. One placebo-treated patient reported transient moderately severe nausea and taste loss. No clinically significant changes were seen in the laboratory data.
  
  
  CONCLUSIONS
  Nedocromil sodium, 4 mg twice daily, conferred significant benefit when added to sustained-release theophylline therapy. The results suggest that nedocromil sodium may permit a reduction in theophylline dosage and possibly substitute for theophylline in previously dependent patients.
authors.affiliation: Peamount Hospital, Newcastle, County Dublin, Ireland.
authors.forename: B
authors.initials: B
authors.lastname: Callaghan
authors.forename: N C
authors.initials: NC
authors.lastname: Teo
authors.forename: L
authors.initials: L
authors.lastname: Clancy
mesh_terms: D000293:Adolescent; D000328:Adult; D000336:Aerosols; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017835:Nedocromil; D015363:Quinolones / Q000008:administration & dosage* / Q000009:adverse effects; D012129:Respiratory Function Tests; D013806:Theophylline / Q000008:administration & dosage
chemical_list: D000336:Aerosols; D000894:Anti-Inflammatory Agents, Non-Steroidal; D001993:Bronchodilator Agents; D015363:Quinolones; D017835:Nedocromil; D013806:Theophylline