Reasons for study discontinuation
renal impairment, bronchiectasis, allergic reaction, swelling, idiopathic bronchiectasis, tinnitus, ototoxicity, COPD
RENAL IMPAIRMENT, BRONCHIECTASIS, ALLERGIC REACTION, ADVERSE EVENTS, TINNITUS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, COPD, IDIOPATHIC BRONCHIECTASIS, ASTHMA, OTOTOXICITY
During the study treatment, a total of 18 (31.6%) patients withdrew from the study: 11 (19.3%) TIS‐treated patients after a mean of 10 weeks (SD 10.6) and 7 (12%) placebo‐treated patients after a mean of 7.7 (SD 6.4) weeks (Overview of reasons for study discontinuation.
Abbreviations: ns, non‐significant; SD, standard deviation.Of these six patients who stopped the study, one TIS‐treated patient (16.7%) was an actual smoker, whereas the other patients never smoked. For one TIS‐treated patient, the etiology of bronchiectasis was defined as asthma; two patients were known to have idiopathic bronchiectasis, one post‐infective, and one with immunodeficiency‐related bronchiectasis. The placebo‐treated patient was known to have asthma‐related bronchiectasis. None of them was known to have chronic obstructive pulmonary disease (COPD) (Table Regarding specific adverse events based on the aminoglycoside safety profile in the patients who have been withdrawn, no TIS‐treated patients experienced ototoxicity; one patient (9%) showed reversible renal impairment after a treatment period of 9 months; and one patient (9%) showed an allergic reaction with swelling and irritation of the lips after the use of TIS, which was not seen during the tolerance test. One (9%) placebo‐treated patient experienced ototoxicity with tinnitus during the treatment period. For this patient, an audiogram was performed, which showed no signs of medication related ototoxicity. An overview of all the adverse events and serious adverse events in the total population is shown in Table 