DISCUSSION
renal impairment, bronchiectasis, dyspnea, heterogenous bronchiectasis, cough, airway hyperresponsiveness
RENAL IMPAIRMENT, BRONCHIECTASIS, ADVERSE EVENTS, AIRWAY OBSTRUCTION, AIRWAY HYPERRESPONSIVENESS, ADVERSE EFFECTS
The present sub‐analysis of the BATTLE studyA total of 57 patients underwent a tolerance test with the first dose of the inhaled medication (TIS or placebo) with salbutamol DA in advance. None of these patients showed a lung function decline or other signs of airway hyperresponsiveness after the tolerance test. Despite a normal tolerance test, airway hyperresponsiveness developed especially during the first weeks of maintenance treatment, whereby in our study, six (10.5%) out of the 57 patients showed airway obstruction, dyspnea, or chronic cough. None of the other adverse effects of TIS during the study could be predicted by the tolerance test.Based on this observation, no additional value was seen for this advised tolerance test; however, closely monitoring in the first weeks after the start of maintenance inhalation treatment seems more relevant.Higher percentages, up to 30%, in the occurrence of airway hyperresponsiveness were described in previous studies with TIS; however, bronchodilation in advance was not standard used in these studies.Only in a few studies in bronchiectasis was a tolerance test or supervised test dose performed before the use of an inhaled treatment option.Maintenance use with inhaled antibiotics is time‐consuming and takes about 20–30 min a day, and it includes the preparation of the device, the use of the inhaled medication, and the cleaning protocol afterwards. This time‐consuming therapy has been a reason for a total of seven patients (38.9%) to be withdrawn from our study. They experienced an insufficient effect of the treatment in combination with a too intensive study schedule. Other adverse events obtained in our study were (reversible) renal impairment after the use of TIS, which was at comparable rates to those described in the recently published iBEST studyIn our study, bronchiectasis patients with pre‐existing low spirometry measurements were included (FEV1 < 50% of predicted), and even in this population, the use of the inhaled study medication was well tolerated. Only one patient dropped out of the study after a period of 3 weeks due to airway hyperresponsiveness despite the use of a bronchodilator.In conclusion, the use of inhaled medication (TIS or NaCl 0.9%) is well tolerated in the heterogenous bronchiectasis population without signs of airway hyperresponsiveness after the first dose of inhaled medication. From this observation, it can be concluded that there is no additional value for this advised tolerance test. However, closely monitoring adverse/site effects during the first weeks of TIS is recommended.