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.
This is a phase 3 study. All bronchiectasis patients will be enrolled from 14 medical centers located in different geographic regions of mainland China. After a three-week screening period, On the basis of usual care \[ambroxool (30mg thrice daily) or N-acetylcysteine (0.2g thrice daily) and chest physiotherapy (5 min, once daily)\], eligible patients will be randomly allocated to treatment group (tobramycin nebulization, 300mg bid, delivered via an ultrasonic nebulizer) and control group (natural saline nebulization, 5ml bid, delivered via an ultrasonic nebulizer). A total of two 28-day on-and-off cycles will be scheduled. At the end of each on-and-off cycle, sputum culture and other clinical assessments will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
350
Tobramycin will be nebulized (300mg twice daily) with an ultrasonic nebulizer. A total of two 28-day on-and-off cycles will be scheduled.
ambroxool (30mg thrice daily), or N-acetylcysteine (0.2g thrice daily) plus chest physiotherapy (5 min, once daily)
Natural saline will be nebulized (5ml twice daily) with an ultrasonic nebulizer. A total of two 28-day on-and-off cycles will be scheduled.
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGChanges in sputum load of Pseudomonas aeruginosa at day 29 compared with baseline
Changes in sputum load of Pseudomonas aeruginosa at day 29 compared with baseline
Time frame: 29 days
Changes in Quality of Life in Bronchiectasis-Respiratory Symptom Score at day 29 compared with baseline
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.
Time frame: 29 days
The time to the first bronchiectasis exacerbation since randomization
The time to the first bronchiectasis exacerbation since randomization
Time frame: 4 months
The frequency of bronchiectasis exacerbation since randomization
The frequency of bronchiectasis exacerbation since randomization
Time frame: 4 months
The rate of isolation of Pseudomonas aeruginosa at day 85
The rate of isolation of Pseudomonas aeruginosa at day 85
Time frame: 85 days
Changes in the load of Pseudomonas aeruginosa at day 85 compared with baseline
Changes in the load of Pseudomonas aeruginosa at day 85 compared with baseline
Time frame: 85 days
Changes in FEV1 pred% at days 29, 57 and 85 compared with baseline
Changes in the predicted % of forced expiratory volume in one second at days 29, 57 and 85 compared with baseline
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Time frame: 85 days
Changes in 24-hour sputum volume at days 29, 57 and 85 compared with baseline
Changes in 24-hour sputum volume at days 29, 57 and 85 compared with baseline
Time frame: 85 days
Changes in sputum purulence at days 29, 57 and 85 compared with baseline
Changes in sputum purulence at days 29, 57 and 85 compared with baseline
Time frame: 85 days
Changes in Quality of Life in Bronchiectasis-Respiratory Symptom Score at day 85 compared with baseline
Changes in QoL-B-RSS at day 85 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.
Time frame: 85 days
Changes in Bronchiectasis Health Questionnaire Sore at day 29 and 85 compared with baseline
Changes in BHQ Sore at day 29 and 85 compared with baseline. Theb BHQ contains 10 items, with higher scores indicating better quality of life. The total score was calculated as the weighted summation of the scores for the 10 individual items.
Time frame: 85 days
Peak and trough concentration of tobramycin at day 1 and 28 post-treatment
Peak and trough concentration of tobramycin at day 1 and 28 post-treatment
Time frame: 29 days
Changes in overall visual analogue scale at days 29 and 85 compared with baseline
Changes in overall VAS at days 29 and 85 compared with baseline. The VAS ranged from 0 to 10, with higher scores indicating poorer status. No summation of the score was made.
Time frame: 85 days
Changes in the minimal inhibitory concentration of Pseudomonas aeruginosa at days 29 and 85 compared with baseline
Changes in the MIC of Pseudomonas aeruginosa at days 29 and 85 compared with baseline (assessed with dilution methods for the sputum culture samples)
Time frame: 85 days