title: Compliance with nedocromil sodium and a nedocromil sodium/salbutamol combination. Compliance Working Group.
abstract: Nonadherence to prescribed preventive medication is common in asthma. We wanted to assess whether the combination of a beta 2-bronchodilator with an anti-inflammatory treatment in the same metered-dose inhaler (MDI) with a regular dosing schedule might improve compliance. A double-blind study was used to compare use (two actuations four times daily for 12 weeks) of 2 mg nedocromil sodium (n = 101) with a combination of 2 mg nedocromil sodium and 100 micrograms salbutamol (n = 100) in mild-to-moderate asthma patients (mean age 42 +/- 14 yrs; 98 males and 103 females). Compliance was measured using the electronic Nebulizer Chronolog (NC) device, change in MDI canister weight, patient questionnaire and physician assessment. The mean +/- SD number of actuations per day for nedocromil sodium and the combination during the primary period of assessment (Weeks 11-12) was 4.2 +/- 2.6 and 4.6 +/- 2.5 (NC), 5.3 +/- 2.1 and 5.3 +/- 2.0 (canister weight), and 7.5 +/- 1.3 and 7.4 +/- 1.3 (questionnaire), respectively. Physician assessment rated compliance as "good" to "excellent". The first and final days of the period were not used in the NC analysis to exclude part-days of treatment and drug-dumping (repeated actuations without inhalation), and may account for the difference between NC and canister weight results. The mean number of two-actuation doses per day determined from the NC was 2.1 +/- 1.3 for nedocromil sodium and 2.4 +/- 2.1 for the combination. Thirty five percent (nedocromil sodium) and 34% (combination) of the patients were compliant (6-10 actuations per day for > or = 60% of the days). We conclude that compliance is poor in asthma, electronic recording revealed the dumping phenomenon and, in this study, the combination of an inhaled beta 2-bronchodilator with a preventive treatment did not improve compliance over a three month period in patients with mild-to-moderate asthma.
authors.affiliation: Laboratoires Fisons S.A., Tour PFA, Paris la Défense, France.
authors.forename: G L
authors.initials: GL
authors.lastname: Braunstein
authors.forename: G
authors.initials: G
authors.lastname: Trinquet
authors.forename: A E
authors.initials: AE
authors.lastname: Harper
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D000420:Albuterol / Q000008:administration & dosage / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D017835:Nedocromil / Q000008:administration & dosage / Q000627:therapeutic use*; D010349:Patient Compliance; D012044:Regression Analysis; D016896:Treatment Outcome
chemical_list: D000318:Adrenergic beta-Agonists; D000893:Anti-Inflammatory Agents; D017835:Nedocromil; D000420:Albuterol