1. Addition of Inhaled Tobramycin to Ciprofloxacin for Acute Exacerbations of Pseudomonas aeruginosa Infection in Adult Bronchiectasis* Diana Bilton, MD; Noreen Henig, MD, FCCP; Brian Morrissey, MD, FCCP and Mark Gotfried, MD, FCCP
CHEST 2006; 130:
Department Of Pulmonary & Critical Care Medicine,
KyungHee Medical Center
R1 유태경

2. Bronchiectasis
- recurrent infection -> local inflammation -> bronchial wall damage
Pseudomonas aeruginosa infection with bronchiectasisis
- more severe disease and a higher utilization of health-care resources
Inhaled tobramycin solution
- reduces the number of acute exacerbations in patients with cystic fibrosis (CF)-related bronchiectasis with P aeruginosa infection
- remains untested in the treatment of exacerbations in patients with non-CF bronchiectasis.

3. Materials and Methods
Design : A double-blind, randomized, active comparator, parallel-design study in 17 study centers
Population - 18 and 80 years of age with bronchiectasis confirmed by HRCT
- CF, allergic bronchopulmonary aspergillosis, active tuberculosis, glucose-6-phosphate dehydrogenase deficiency, significant renal disease, or a change in steroid therapy within 2 weeks of the acute exacerbation were excluded
- chronic P aeruginosa lung infection, confirmed by a sputum culture positive both within the 12 months before screening and at the time of screening
-P aeruginosa of Cip sensitivity at the time of study enrollment.

4. Materials and Methods Procedures - three medications
(1) 750 mg of oral Cip
(2) 300 mg per 5 mL of TIS aerosolized with a jet nebulizer
(3) 1.25 mg of quinine sulfate per 5 mL of inhalation solution aerosolized a jet nebulizer
- two active treatment arms
(1) therapy twice daily with TIS and twice daily with Cip (TIS/Cip arm)
(2) twice-daily therapy with placebo and Cip (placebo/Cip arm).

5. Materials and Methods End Points 1. two clinical outcome assessments
- day 14 : resolved (all signs and symptoms had returned to the preexacerbation state), improved(not fully resolved or residual symptoms), not improved (no change or condition had worsened)
- day 21 : cure (resolution or improvement of symptoms ), failure (persistence or worsening of symptoms , hospitalization, additional antimicrobial therapy), indetermine (missing data, unclear response)
- day 42 : classified as at day 21 except relapse( cure on day 21, but required retreatment)
2. microbiological response (D 21)
- eradicated : no P aeruginosa infection
- persistent : P aeruginosa infection
- superinfected : new pathogen and new or worsening symptoms
- indeterminate : unable to be otherwise classified

6. Results : Subject Demographics

7. Results : Efficacy Analyses

8. Results : Efficacy Analyses

9. Results : Microbiological Analysis

10. Results : Microbiological Analysis

11. Results : Microbiological Analysis

12. Results : Safety Analyses

13. Discussion
first randomized controlled trial of a nebulized antibiotic as adjunctive therapy for patients with an acute exacerbation of P aeruginosa infection in patients with non-CF bronchiectasis
first study of an acute exacerbation of P aeruginosa infection in bronchiectasis patients in which quantitative microbiology measurements have been performed.

14. disparity between microbiological and clinical efficacy
->treatment-related wheeze led to the classification of an outcome as clinical failure
time-to-next-exacerbation and time-to-next-exacerbation-requiring-hospitalization should be assessed in future studies