Efficacy and Safety of Inhaled Tobramycin on Bronchiectasis Colonized With Pseudomonas Aeruginosa: A Randomized, Double-blind, Parallel-group Multicenter Trial (TORNASOL)

NCT03715322 Phase 3 UNKNOWN

This is a phase 3 study. Patients will be enrolled from 14 medical centers in mainland China. Eligible patients will be randomly allocated to treatment group (tobramycin nebulization, 300mg bid) and control group (natural saline nebulization, 5ml bid). A total of two 28-day on-and-off cycles will be scheduled. Both tobramycin solution and natural saline and the nebulizer will be solely provided by the sponsor.

Details

Lead sponsor	Guangzhou Institute of Respiratory Disease
Phase	Phase 3
Status	UNKNOWN
Enrolment	350
Start date	2018-10-26
Completion	2021-06

Conditions

• Bronchiectasis Adult
• Pseudomonas Infections

Interventions

• Tobramycin Inhalant Product
• usual care
• Natural saline inhalation

Primary outcomes

• Changes in sputum load of Pseudomonas aeruginosa at day 29 compared with baseline — 29 days
  Changes in sputum load of Pseudomonas aeruginosa at day 29 compared with baseline
• Changes in Quality of Life in Bronchiectasis-Respiratory Symptom Score at day 29 compared with baseline — 29 days
  Changes in QoL-B-RSS at day 29 compared with baseline. The respiratory symptom domain contains 9 items describing patient's self assessment of her/his respiratory symptoms that affect the daily life. The total score for this domain is 100, with higher scores indicating better quality of life. No summation was made for the total score.

Countries

China