Compliance with nedocromil sodium and a nedocromil sodium/salbutamol combination

Abstract

Nonadherence to prescribed preventive medication is common in asthma. We wanted to assess whether the combination of a β2-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 μg 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 ≥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 β2-bronchodilator with a preventive treatment did not improve compliance over a three month period in patients with mild-to-moderate asthma.