Eficacia de la terapia de aplicación puntual para el asma bronquial: un ensayo controlado aleatorizado multicéntrico

To assess the efficacy of point application therapy (PAT) in alleviating the exacerbation of chronic respiratory diseases represented by bronchial asthma.

In this multicenter randomized placebo-controlled trial, eligible bronchial asthma patients received placebo PAT on the dog days of the first summer to establish a baseline, and then patients who continued to participate in the trial and repassed the eligibility review were randomized to receive regular or placebo PAT in the next two consecutive summers. The primary outcome was the change from baseline in the number of asthma exacerbations at 24 months. Secondary outcomes included severity of asthma exacerbation, asthma control test (ACT) score, percentage of forced expiratory volume in 1 s (FEV₁) to the predicated value (FEV₁%pred), peak expiratory flow (PEF), ratio of FEV₁ to forced vital capacity (FEV₁/FVC), and use of palliative drugs during bronchial asthma exacerbations at 12 and 24 months. The adverse events (AEs) were also assessed.

A total of 835 patients with bronchial asthma were randomized in this trial. Compared with the placebo control, the PAT significantly decreased the mean number of asthma exacerbations (1.42; 95% confidence interval, 0.69 to 2.14; P < 0.001), and increased the FEV₁%pred at 24 months (P = 0.039) and FEV₁/FVC at 12 months (P = 0.01) and 24 months (P = 0.01). There were no significant differences between the groups in PEF or ACT score at 12 and 24 months, or in FEV₁%pred at 12 months. Treatment-related AEs were mild and more common in the PAT group than in the placebo PAT group. No serious AEs were reported.

PAT conducted on dog days could reduce asthma exacerbations in patients with bronchial asthma.