Bronchiectasis AdultPhase 3TORNASOLNCT03715322
Tobramycin in Bronchiectasis Colonized With Pseudmonas Aeruginosa
A Phase 3 study testing Tobramycin Inhalant Product and Natural saline inhalation in people with Bronchiectasis Adult and Pseudomonas Infections, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bronchiectasis Adult, Pseudomonas Infections
- What is being tested?
- Tobramycin Inhalant Product and Natural saline inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2018to Jun 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Nan-shan Zhong, MD, +86-13609003622, nanshan@vip.163.com
Wei-jie Guan, PhD
About this study
Official title: Efficacy and Safety of Inhaled Tobramycin on Bronchiectasis Colonized With Pseudomonas Aeruginosa: A Randomized, Double-blind, Parallel-group Multicenter Trial
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.
Read the 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.
- Conditions
- Bronchiectasis Adult, Pseudomonas Infections
- Being tested
- Tobramycin Inhalant Product, usual care, Natural saline inhalation
- Keywords
- bronchiectasis, Pseudomonas aeruginosa, tobramycin, nebulization, bacterial load, quality of life
- Medical subject headings
- Pseudomonas Infections, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobramycin Inhalant ProductDrug
Tobramycin will be nebulized (300mg twice daily) with an ultrasonic nebulizer. A total of two 28-day on-and-off cycles will be scheduled.
usual careOther
ambroxool (30mg thrice daily), or N-acetylcysteine (0.2g thrice daily) plus chest physiotherapy (5 min, once daily)
Natural saline inhalationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| tobramycin inhalation | Active comparator | 300mg tobramycin dissolved in 5ml saline will be nebulized with an ultrasonic nebulizer within 15-20 minutes. Receives: Drug: Tobramycin Inhalant Product; Other: usual care |
| natural saline inhalation | Placebo comparator | 5ml saline will be nebulized with an ultrasonic nebulizer within 15-20 minutes. Receives: Other: usual care; Drug: Natural saline inhalation |
| usual care | Other | ambroxool (30mg thrice daily), or N-acetylcysteine (0.2g thrice daily) plus chest physiotherapy (5 min, once daily) Receives: Drug: Tobramycin Inhalant Product; Drug: Natural saline inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 29 days
Secondary outcomes (12)
The time to the first bronchiectasis exacerbation since randomization
The time to the first bronchiectasis exacerbation since randomization
Measured: 4 months
The frequency of bronchiectasis exacerbation since randomization
The frequency of bronchiectasis exacerbation since randomization
Measured: 4 months
The rate of isolation of Pseudomonas aeruginosa at day 85
The rate of isolation of Pseudomonas aeruginosa at day 85
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start26 Oct 2018
- Primary completionApr 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into the treatment group and control group. No cross-over of the study group will be made.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijie Guan, Guangzhou Institute of Respiratory Disease
- Investigators
- Nan-shan Zhong, MD, Study chair, The First Affiliated Hospital of Guangzhou Medical UniversityWei-jie Guan, PhD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715322
- Sponsor's protocol ID
- GIRH-2018-TOBRA
- Acronym
- TORNASOL
- Status last verified
- Jul 2019
- First submitted
- 19 Oct 2018
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pasteur MC, Bilton D, Hill AT; British Thoracic Society Bronchiectasis non-CF Guideline Group. British Thoracic Society guideline for non-CF bronchiectasis. Thorax. 2010 Jul;65 Suppl 1:i1-58. doi: 10.1136/thx.2010.136119.
PubMed 20627931Pasteur MC, Helliwell SM, Houghton SJ, Webb SC, Foweraker JE, Coulden RA, Flower CD, Bilton D, Keogan MT. An investigation into causative factors in patients with bronchiectasis. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1277-84. doi: 10.1164/ajrccm.162.4.9906120.
PubMed 11029331Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Li HM, Lin ZM, Zheng JP, Chen RC, Zhong NS. Aetiology of bronchiectasis in Guangzhou, southern China. Respirology. 2015 Jul;20(5):739-48. doi: 10.1111/resp.12528. Epub 2015 Mar 26.
PubMed 25819403Angrill J, Agusti C, De Celis R, Filella X, Rano A, Elena M, De La Bellacasa JP, Xaubet A, Torres A. Bronchial inflammation and colonization in patients with clinically stable bronchiectasis. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1628-32. doi: 10.1164/ajrccm.164.9.2105083.
PubMed 11719301Chalmers JD, Smith MP, McHugh BJ, Doherty C, Govan JR, Hill AT. Short- and long-term antibiotic treatment reduces airway and systemic inflammation in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2012 Oct 1;186(7):657-65. doi: 10.1164/rccm.201203-0487OC. Epub 2012 Jun 28.
PubMed 22744718Davies G, Wells AU, Doffman S, Watanabe S, Wilson R. The effect of Pseudomonas aeruginosa on pulmonary function in patients with bronchiectasis. Eur Respir J. 2006 Nov;28(5):974-9. doi: 10.1183/09031936.06.00074605. Epub 2006 Aug 9.
PubMed 16899482Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Li HM, Li ZM, Zheng JP, Chen RC, Zhong NS. Effect of airway Pseudomonas aeruginosa isolation and infection on steady-state bronchiectasis in Guangzhou, China. J Thorac Dis. 2015 Apr;7(4):625-36. doi: 10.3978/j.issn.2072-1439.2015.04.04.
PubMed 25973228Wilson R, Aksamit T, Aliberti S, De Soyza A, Elborn JS, Goeminne P, Hill AT, Menendez R, Polverino E. Challenges in managing Pseudomonas aeruginosa in non-cystic fibrosis bronchiectasis. Respir Med. 2016 Aug;117:179-89. doi: 10.1016/j.rmed.2016.06.007. Epub 2016 Jun 7.
PubMed 27492530Orriols R, Hernando R, Ferrer A, Terradas S, Montoro B. Eradication Therapy against Pseudomonas aeruginosa in Non-Cystic Fibrosis Bronchiectasis. Respiration. 2015;90(4):299-305. doi: 10.1159/000438490. Epub 2015 Sep 5.
PubMed 26340658Hoppentocht M, Akkerman OW, Hagedoorn P, Alffenaar JW, van der Werf TS, Kerstjens HA, Frijlink HW, de Boer AH. Tolerability and Pharmacokinetic Evaluation of Inhaled Dry Powder Tobramycin Free Base in Non-Cystic Fibrosis Bronchiectasis Patients. PLoS One. 2016 Mar 9;11(3):e0149768. doi: 10.1371/journal.pone.0149768. eCollection 2016.
PubMed 26959239Bilton D, Henig N, Morrissey B, Gotfried M. Addition of inhaled tobramycin to ciprofloxacin for acute exacerbations of Pseudomonas aeruginosa infection in adult bronchiectasis. Chest. 2006 Nov;130(5):1503-10. doi: 10.1378/chest.130.5.1503.
PubMed 17099030Scheinberg P, Shore E. A pilot study of the safety and efficacy of tobramycin solution for inhalation in patients with severe bronchiectasis. Chest. 2005 Apr;127(4):1420-6. doi: 10.1378/chest.127.4.1420.
PubMed 15821224Drobnic ME, Sune P, Montoro JB, Ferrer A, Orriols R. Inhaled tobramycin in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection with Pseudomonas aeruginosa. Ann Pharmacother. 2005 Jan;39(1):39-44. doi: 10.1345/aph.1E099. Epub 2004 Nov 23.
PubMed 15562142Couch LA. Treatment With tobramycin solution for inhalation in bronchiectasis patients with Pseudomonas aeruginosa. Chest. 2001 Sep;120(3 Suppl):114S-117S. doi: 10.1378/chest.120.3_suppl.114s.
PubMed 11555565Orriols R, Roig J, Ferrer J, Sampol G, Rosell A, Ferrer A, Vallano A. Inhaled antibiotic therapy in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection by Pseudomonas aeruginosa. Respir Med. 1999 Jul;93(7):476-80. doi: 10.1016/s0954-6111(99)90090-2.
PubMed 10464834
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Inhaled Tobramycin on Bronchiectasis Colonized With Pseudomonas Aeruginosa: A Randomized, Double-blind, Parallel-group Multicenter Trial
- ClinicalTrials.gov ID
- NCT03715322
- Acronym / sponsor ID
- TORNASOL / GIRH-2018-TOBRA
- Conditions
- Bronchiectasis Adult, Pseudomonas Infections
- Keywords
- bronchiectasis, Pseudomonas aeruginosa, tobramycin, nebulization, bacterial load, quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Patients will be randomized into the treatment group and control group. No cross-over of the study group will be made.
| Arm | Type | Receives |
|---|---|---|
| tobramycin inhalation | Active comparator | Drug: Tobramycin Inhalant Product, Other: usual care300mg tobramycin dissolved in 5ml saline will be nebulized with an ultrasonic nebulizer within 15-20 minutes. |
| natural saline inhalation | Placebo comparator | Other: usual care, Drug: Natural saline inhalation5ml saline will be nebulized with an ultrasonic nebulizer within 15-20 minutes. |
| usual care | Other | Drug: Tobramycin Inhalant Product, Drug: Natural saline inhalationambroxool (30mg thrice daily), or N-acetylcysteine (0.2g thrice daily) plus chest physiotherapy (5 min, once daily) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobramycin Inhalant ProductTobramycin will be nebulized (300mg twice daily) with an ultrasonic nebulizer. A total of two 28-day on-and-off cycles will be scheduled. | Drug | tobramycin inhalation, usual care |
| usual careambroxool (30mg thrice daily), or N-acetylcysteine (0.2g thrice daily) plus chest physiotherapy (5 min, once daily) | Other | natural saline inhalation, tobramycin inhalation |
| Natural saline inhalationNatural saline will be nebulized (5ml twice daily) with an ultrasonic nebulizer. A total of two 28-day on-and-off cycles will be scheduled. | Drug | natural saline inhalation, usual care |
Primary outcome
Changes in sputum load of Pseudomonas aeruginosa at day 29 compared with baseline
Time frame: 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
Time frame: 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.
12 secondary outcomes
The time to the first bronchiectasis exacerbation since randomization
Time frame: 4 months
The frequency of bronchiectasis exacerbation since randomization
Time frame: 4 months
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
Time frame: 85 days
Changes in FEV1 pred% at days 29, 57 and 85 compared with baseline
Time frame: 85 days
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
Time frame: 85 days
Changes in Quality of Life in Bronchiectasis-Respiratory Symptom Score at day 85 compared with baseline
Time frame: 85 days
Changes in Bronchiectasis Health Questionnaire Sore at day 29 and 85 compared with baseline
Time frame: 85 days
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
Time frame: 85 days
Changes in the minimal inhibitory concentration of Pseudomonas aeruginosa at days 29 and 85 compared with baseline
Time frame: 85 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Background: PubMed 20627931Pasteur MC, Bilton D, Hill AT; British Thoracic Society Bronchiectasis non-CF Guideline Group. British Thoracic Society guideline for non-CF bronchiectasis. Thorax. 2010 Jul;65 Suppl 1:i1-58. doi: 10.1136/thx.2010.136119.
- Background: PubMed 11029331Pasteur MC, Helliwell SM, Houghton SJ, Webb SC, Foweraker JE, Coulden RA, Flower CD, Bilton D, Keogan MT. An investigation into causative factors in patients with bronchiectasis. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1277-84. doi: 10.1164/ajrccm.162.4.9906120.
- Background: PubMed 25819403Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Li HM, Lin ZM, Zheng JP, Chen RC, Zhong NS. Aetiology of bronchiectasis in Guangzhou, southern China. Respirology. 2015 Jul;20(5):739-48. doi: 10.1111/resp.12528. Epub 2015 Mar 26.
- Background: PubMed 11719301Angrill J, Agusti C, De Celis R, Filella X, Rano A, Elena M, De La Bellacasa JP, Xaubet A, Torres A. Bronchial inflammation and colonization in patients with clinically stable bronchiectasis. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1628-32. doi: 10.1164/ajrccm.164.9.2105083.
- Background: PubMed 22744718Chalmers JD, Smith MP, McHugh BJ, Doherty C, Govan JR, Hill AT. Short- and long-term antibiotic treatment reduces airway and systemic inflammation in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2012 Oct 1;186(7):657-65. doi: 10.1164/rccm.201203-0487OC. Epub 2012 Jun 28.
- Background: PubMed 16899482Davies G, Wells AU, Doffman S, Watanabe S, Wilson R. The effect of Pseudomonas aeruginosa on pulmonary function in patients with bronchiectasis. Eur Respir J. 2006 Nov;28(5):974-9. doi: 10.1183/09031936.06.00074605. Epub 2006 Aug 9.
- Background: PubMed 25973228Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Li HM, Li ZM, Zheng JP, Chen RC, Zhong NS. Effect of airway Pseudomonas aeruginosa isolation and infection on steady-state bronchiectasis in Guangzhou, China. J Thorac Dis. 2015 Apr;7(4):625-36. doi: 10.3978/j.issn.2072-1439.2015.04.04.
- Background: PubMed 27492530Wilson R, Aksamit T, Aliberti S, De Soyza A, Elborn JS, Goeminne P, Hill AT, Menendez R, Polverino E. Challenges in managing Pseudomonas aeruginosa in non-cystic fibrosis bronchiectasis. Respir Med. 2016 Aug;117:179-89. doi: 10.1016/j.rmed.2016.06.007. Epub 2016 Jun 7.
- Background: PubMed 26340658Orriols R, Hernando R, Ferrer A, Terradas S, Montoro B. Eradication Therapy against Pseudomonas aeruginosa in Non-Cystic Fibrosis Bronchiectasis. Respiration. 2015;90(4):299-305. doi: 10.1159/000438490. Epub 2015 Sep 5.
- Background: PubMed 26959239Hoppentocht M, Akkerman OW, Hagedoorn P, Alffenaar JW, van der Werf TS, Kerstjens HA, Frijlink HW, de Boer AH. Tolerability and Pharmacokinetic Evaluation of Inhaled Dry Powder Tobramycin Free Base in Non-Cystic Fibrosis Bronchiectasis Patients. PLoS One. 2016 Mar 9;11(3):e0149768. doi: 10.1371/journal.pone.0149768. eCollection 2016.
- Background: PubMed 17099030Bilton D, Henig N, Morrissey B, Gotfried M. Addition of inhaled tobramycin to ciprofloxacin for acute exacerbations of Pseudomonas aeruginosa infection in adult bronchiectasis. Chest. 2006 Nov;130(5):1503-10. doi: 10.1378/chest.130.5.1503.
- Background: PubMed 15821224Scheinberg P, Shore E. A pilot study of the safety and efficacy of tobramycin solution for inhalation in patients with severe bronchiectasis. Chest. 2005 Apr;127(4):1420-6. doi: 10.1378/chest.127.4.1420.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nan-shan Zhong, MD study chair
The First Affiliated Hospital of Guangzhou Medical University
Wei-jie Guan, PhD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tobramycin Inhalant Product and Natural saline inhalation in people with Bronchiectasis Adult and Pseudomonas Infections, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nan-shan Zhong, MD (13609003622, nanshan@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sputum load of Pseudomonas aeruginosa at day 29 compared with baseline (time frame: 29 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03715322, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.