Have you or your loved ones been diagnosed with bronchiectasis adult?
You may be eligible to participate in a bronchiectasis adult clinical trial.
Have you or your loved ones been diagnosed with bronchiectasis adult? You may be eligible to participate in a bronchiectasis adult clinical trial.
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Bronchiectasis Adult Clinical Trial in Guangzhou Guangdong
Have you or your loved ones been diagnosed with bronchiectasis adult?
You may be eligible to participate in a bronchiectasis adult clinical trial.
Have you or your loved ones been diagnosed with bronchiectasis adult? You may be eligible to participate in a bronchiectasis adult clinical trial.
Recruiting
Male & Female
18 - 75
Years old
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 for the study
Brief Title
Tobramycin in Bronchiectasis Colonized With Pseudmonas Aeruginosa
Official Title
Efficacy and Safety of Inhaled Tobramycin on Bronchiectasis Colonized With Pseudomonas Aeruginosa: A Randomized, Double-blind, Parallel-group Multicenter Trial
Brief Summary
This is a phase 3 study. Patients will be enrolled from 14 medical centers in mainland China.<br /> Eligible patients will be randomly allocated to treatment group (tobramycin nebulization,<br /> 300mg bid) and control group (natural saline nebulization, 5ml bid). A total of two 28-day<br /> on-and-off cycles will be scheduled. Both tobramycin solution and natural saline and the<br /> nebulizer will be solely provided by the sponsor.
Detailed Description
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.
Treatments and/or Procedures
Tobramycin inhalant product
Tobramycin will be nebulized (300mg twice daily) with an ultrasonic nebulizer. A total of two 28-day on-and-off cycles will be scheduled.
Natural saline inhalation
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.
Usual care
ambroxool (30mg thrice daily), or N-acetylcysteine (0.2g thrice daily) plus chest physiotherapy (5 min, once daily)
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
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.
Primary
Changes 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
Secondary
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
Secondary
The time to the first bronchiectasis exacerbation since randomization
The time to the first bronchiectasis exacerbation since randomization
Secondary
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
Secondary
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
Secondary
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
Secondary
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.
Secondary
The frequency of bronchiectasis exacerbation since randomization
The frequency of bronchiectasis exacerbation since randomization
Secondary
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
Secondary
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.
Secondary
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)
Secondary
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.
Secondary
The rate of isolation of Pseudomonas aeruginosa at day 85
The rate of isolation of Pseudomonas aeruginosa at day 85
Study Criteria
Inclusion Criteria: - Aged 18 to 75 years, had a history of chronic cough and sputum production, had physician-diagnosed bronchiectasis based on high-resolution chest computed tomography (effective within 12 months) - Remaining clinically stable (no significant changes in respiratory symptoms and free from upper respiratory tract infection or bronchiectasis exacerbations for 4 weeks) - Sputum culture positive to Pseudomonas aeruginosa at screening - Forced expiratory volume in one second > 30% predicted and < 80% predicted - Could tolerate to nebulization - At least one bronchiectasis exacerbation within the past two years - Can correctly nebulize the study medications and fill in the diary cards following instruction of the investigators Exclusion Criteria: - Had a knwon history of allergy to tobramycin - Had concomitant asthma, allergic bronchopulmonary aspergillosis, active tuberculosis, or active infection with non-tuyberculous mycobacteria that warranted regular anti-mycobacterial treatment - Had moderate or major haemoptysis within 6 months - Had concomitant severe cardiovascular diseases or haematopoietic diseases (congestive heart failure, clinically significant coronary heart disease, myocardial infarction or stroke, clinically arrythmia, known anurysm of the aorta, uncontroll hypertension (systolic blood pressure > 160mmHg or diastolic pressure >100mmHg at two consecutive time points) - Concomitant severe psychiatric disorders - Uncontrolled diabetes mellitus or fasting blood glucose >10mmol/L - Active peptic or duodenal ulcer - Moderate-to-severe gastroesophageal reflux diseases - Malignancy - Severe myasthenia gravis or Parkinson's disease - Major abnormality of hepatic or renal function [ALT or AST >2-fold of the normal upper limit, creatinine > 1.5-fold- greater than the normal upper limit (excluding ALT > 1.5-fold greater than normal upper limit in patients with chronic stable hepatitis)]; concomitant infection with HBV and HCV; - Hearing loss or clinically significant tinittus - Use of inhaled or systemic antibiotics within 4 weeks prior to enrollment - Needing oral or intravenous corticosteroids, or needing systemic corticosteroids within 30 days prior to enrollment - Needing oral or intravenous anti-cholinergic medications, or needing systemic anti-cholinergic medications within 30 days prior to enrollment - Needing long-term non-invasive mechanical ventilation or oxygen therapy (> 10 hrs daily) due to chronic respiratory failure - Pregnancy or lactation - Failure to understand or cooperate with the trial procedures - Participation in other clinical trials within 3 months