Background In the clinical trial setting, TOBI Podhaler (TIP) has been shown to be non-inferior to nebulised Tobramycin Inhalation Solution (TIS) in CF subjects in terms of effects on lung function, with increased adverse events but overall superior patient satisfaction. However, there is currently little ‘real world’ evidence of tolerance and effectiveness of TIP.
Aim To assess the experience of CF adults receiving TIP at our large regional UK adult CF centre.
Methods We report the preliminary results of a prospective observational study to evaluate changes in lung function, tolerability and antibiotic requirements of 73 CF adults that have received at least one dose of TIP at our centre to date. Patients also completed a visual analogue scale (VAS) score of tolerance, convenience, satisfaction and likelihood to continue (1 = very satisfied/not at all severe/very likely, 10 = not at all satisfied/very severe/not at all likely) at their 28-day review.
Results Adverse events (AEs) were common following the test dose (most commonly cough in 24/73, 32.9%), although only 1 patient discontinued treatment, due to a 10% drop in FEV1% predicted. 27/72 patients so far have completed 28 days treatment, with median change in FEV1% predicted of –1.7% (IQR –6.1 to 2.4%). 12/27 patients (44.4%) reported AEs at their 28-day review; most commonly cough (10 patients, 37.0%), with median VAS score for severity of all AEs of 4/10. 12/27 patients (44.4%) were commenced on oral or IV antibiotics for pulmonary exacerbation at their 28-day review. Median VAS scores for overall satisfaction, ease of administration, and likelihood to continue were all 1/10. 12/72 patients to date have discontinued TIP before completion (10 patients) or at completion (2 patients) of 28 days treatment, 8 (66.7%) of whom were previously intolerant of TIS. The most common reason for discontinuation was cough (9/12 patients, 75.0%), with median VAS score for severity of all AEs 7/10.
Conclusion Despite experiencing a high incidence of adverse events, patients commencing TIP report high levels of treatment satisfaction.