Non-chlorofluorocarbons containing propellant — the new aspect of inhalation treatment

Abstract

This multi-centre, randomised, double-blind, parallel group 12-week ‘switch’ study have compared the tolerability and efficacy of 200 meg salbutamol/propellants 11/12 qds and 200 meg salbutamol/GR106642X qds in adult patients with reversible airway obstruction. A total of 547 patients were randomised to treatment; 277 patients received salbutamol/GR106642X and 270 patients — salbutamol/propellants 11/12. Nineteen patients were withdrawn from the 12-week treatment period. There were no changes in heart rate over the treatment period (mean change from the baseline was 0 beats per minute). Statistical analysis showed that there was no difference between the two formulations. The findings of this primary tolerability variable were supported by the analysis of the secondary efficacy variables. The frequency and variants of adverse events was similar in patients received salbutamol/GR106642X (32% ) and patients received salbutamol/propellants 11/12 (36% ) and in control group and there was a small difference in the frequency of individual adverse events. There was a low frequency of the pharmacologically predictable events such as headache, tremors, palpitations and tachycardia in both groups. There were no reports of paradoxical bronchospasm, muscle cramps or hypokaliemia. Eight patients experienced serious adverse events during the treatment period including six persons from the salbutamol/GR106642X group. Two patients received salbutamol/GR106642X and 3 patients received salbutamol/propellants 11/12 were withdrawn because of adverse events. This study have demonstrated clinical equivalence in tolerability and efficacy of 200 meg salbutamol/propellants 11/12 qds and 200 meg salbutamol/GR106642X qds.