[Reference controlled, randomized double-blind study of the effectiveness of a salbutamol/DNCG DA combination in...

We examined 20 patients in whom bronchial hyperreactivity and positive inhalative methacholine provocation test (dosage-effect curve) had been known for at least 3 months at the time of study. The patients received randomised either DA Salbutamol/DNCG (0.1 mg Salbutamol and 1.0 mg DNCG/puff) or DA Salbutamol alone (0.1 mg Salbutamol puff). In each case the therapy consisted of 4 x 2 puffs daily. The minimum treatment time was 14 days. The average treatment time was 16 days in both groups. The major aim of the study was to find out whether treatment with the combination preparation in the inhalative methacholine test would lead to a higher provocation dose (PD) for the Rt value and/or sGaw and/or FEV1 representing an alleviation of bronchial hyperreactivity, compared with the pre-examination and with the control group with Salbutamol monotherapy. In addition, the effectivity was to be documented by means of peak-flow values to be measured by the patient himself. The results show in both groups a mild but statistically not significant reduction of the provocation reaction in the inhalative methacholine provocation test in the sense of an improvement in bronchial hyperreactivity. No significant difference between the therapy groups, and especially no superiority of the combination treatment, is evident.