Pneumologie 2016; 70 - A14
DOI: 10.1055/s-0036-1592238

Baseline therapies for Bronchiectasis (non-CF etiology) vary by country – data from the RESPIRE1 trial of Ciprofloxacin Dry Powder for Inhalation (DPI)

A De Soyza 1, T Aksamit 2, TJ Bandel 3, M Criollo 4, JS Elborn 5, E Operschall 3, E Polverino 6, K Winthrop 7, R Wilson 8
  • 1Newcastle University and Freeman Hospital
  • 2Mayo Clinic, Rochester
  • 3Bayer Pharma AG
  • 4Bayer Inc.
  • 5Queen's University Belfast
  • 6Fundacio Clinic, IDIBAPS, CIBERES
  • 7Oregon Health & Science University
  • 8Royal Brompton Hospital

Background:

RESPIRE 1, an international Phase III trial, aimed to evaluate if Ciprofloxacin DPI as long-term, intermittent therapy in bronchiectasis patients (non-CF etiology) with ≥2 exacerbations (prior 12 months) and respiratory pathogens reduces exacerbations and improves quality-of-life (QoL). We investigated concomitant treatment use at baseline in different countries.

Methods:

We analysed preliminary baseline demographics, disease characteristics, and treatment use of subjects randomised in RESPIRE1 by country. Countries that contributed > 1% of the full cohort were evaluated for numerical differences in the sub-analysis.

Results:

416 subjects enrolled in 14 countries were analysed. Six countries enrolled 11 – 13% subjects each (Australia/Germany/Spain/Israel/New Zealand/US), three contributed 5 – 8% each (UK/Italy/Japan) and three enrolled 1 – 4% (Argentina/France/Latvia), while two randomised < 1% (Denmark/Slovakia). Baseline data for the full cohort are reported in Table 1. Mean (range) patient age in the full cohort was 64.7 (51.5 – 70.4) years. Patients from the US/Israel/France/Argentina reported poorer QoL (total St Georges Respiratory Questionnaire (SGRQ) score > 4 points above full cohort mean [44.9 vs. 51.8/54.4/57.9/58.6, respectively]). Patients in UK/New Zealand/Spain had the highest rates of ICS use, including ICS/LABA combination (66.7%/52.9%/46.9%, respectively) while Germany/Latvia/Japan had the lowest (21.3%/18.8%/15.2%, respectively). Patients in Japan had comparatively high usage rates of long-term macrolides (69.7%) and mucolytics (75.8%). Lower macrolide usage rates of 0%/5.9%/8.5% were observed in Israel/New Zealand/Germany, respectively. Long-acting bronchodilator use in Spain was high (LABA, 40.8%; LAMA, 24.5%) and low in US patients (LABA, 15.9%; LAMA, 9.1%) although SABA use in US patients was high (68.2%).

Conclusions:

Between countries, demographics of patients enrolled in RESPIRE 1 were generally similar. Numerical differences in baseline concomitant therapy may result from low patient numbers and center effect, or reflect inter-country management differences and lack of international treatment guidelines.