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Bronchiectasis AdultPhase 4ERASENCT06093191

Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Bronchiectasis

A Phase 4 study testing Tobramycin Inhalant Product, Ciprofloxacin 750 MG and Natural saline inhalation in people with Bronchiectasis Adult and Pseudomonas Aeruginosa Infection, run by Jin-Fu Xu at 60 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

People with bronchiectasis are prone to Pseudomonas aeruginosa (PA) infections, which can become chronic and lead to increased death rates and disease severity. Studies from cystic fibrosis suggest that eradication therapy aimed at PA can successfully transition patients to a culture-negative status, providing… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Tobramycin Inhalant Product, Ciprofloxacin 750 MG and Natural saline inhalation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
371 participants
Where
60 sitesChina
Study dates
18 Oct 2023to 15 Nov 2025
Phase
Phase 4
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged 18 years and 80 years at screening
  • Signed and dated written informed consent prior to admission to the study in accordance with local legislation.
  • Clinical history consistent with bronchiectasis (cough, chronic sputum production and/or recurrent respiratory infections) and investigator-confirmed diagnosis of bronchiectasis by high-resolution CT (HRCT) scan
  • Positive sputum culture for PA during screening, and meeting one of the following three conditions:
  • ① No prior isolation of PA from respiratory secretions (a positive sputum culture from the study hospital within 1 month before screening was accepted, provided that no antibiotics were used for ≥14 days before the culture);
  • ② First isolated PA within 12 months prior to screening, but did not undergo eradication therapy (continuous oral/intravenous/inhaled antibiotic treatment ≥1 month, excluding macrolides);
Show all 10Show fewer
  • ③ Previously isolated PA, but respiratory secretions were negative for PA at least twice (separated by an interval of ≥3 months) for 24 months or more prior to screening (Requirement: respiratory secretion isolation results obtained while not using antibiotics for 14 days or more);
  • During the screening period, patients must remain clinically stable (no significant changes in daytime and nighttime respiratory symptoms and no upper respiratory tract infection or bronchiectasis exacerbations for 4 weeks)
  • During the screening period, P. aeruginosa is not resistant to Tobramycin and Ciprofloxacin based on the drug sensitivity test of sputum culture in vitro
  • Patient can tolerate nebulized inhalation therapy

Who cannot join

  • Patients who are allergic to or cannot tolerate the investigational drugs (Tobramycin, Ciprofloxacin)
  • Comorbid uncontrolled asthma (defined as ≥1 acute exacerbation within 1 week prior to screening); confirmed bronchiectasis due to cystic fibrosis; Allergic Bronchopulmonary Aspergillosis (ABPA); active pulmonary tuberculosis; or nontuberculous mycobacterial infection requiring standard anti-nontuberculous treatment;
  • Participants with unstable cardiovascular and cerebrovascular diseases, defined as those who have experienced clinically worsening symptoms (such as unstable angina, rapid atrial fibrillation, cerebral hemorrhage, acute cerebral infarction, etc.) or have been hospitalized due to these diseases within 90 days prior to the screening
  • Participants with progressive or uncontrolled systemic diseases, such as those affecting the urinary, hematological, digestive, endocrine, respiratory, circulatory, nervous, or mental systems, are not suitable for this clinical trial. This is particularly the case if these conditions are evaluated by the researcher as being unstable or potentially escalating into severe conditions during the trial.
  • AST and/or ALT >2 ULN and/or Total Bilirubin (TBIL) at screening period
  • Serum creatinine >ULN at screening period
Show all 14Show fewer
  • Participants with a history of hearing loss or those who are determined by the researcher to have clinically significant chronic tinnitus
  • Participants with a history of prolonged QT intervals or those whose electrocardiograms show prolonged QT intervals during the screening period
  • Participants who have used drugs that are prohibited according to the plan during the screening period.
  • Women who are pregnant or lactating, or women of childbearing potential preparing for pregnancy
  • Patients with FEV1% of predicted value<30%
  • Participants who have participated in other clinical trials (defined as those where medication has been administered) within the 4 weeks prior to the screening
  • Participants who have experienced moderate or severe hemoptysis (defined as expectorating 100-500ml of blood in 24 hours for moderate hemoptysis; and expectorating more than 500ml in 24 hours, or a single instance of expectorating more than 100ml of blood for severe hemoptysis) due to bronchiectasis within the past 6 months.
  • Participants who are deemed unsuitable for inclusion in the study due to other reasons, as determined by the researcher.

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

China60 sites

  • The First People's Hospital of Anning Affiliated to Kunming University of Science and Technology

    Anning, Yunnan

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • The First Hospital of Jilin University

    Changchun, Jilin

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • Xiangya Hospital, Central South University

    Changsha, Hunan

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • The Third Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

  • Fujian Provincial Hospital

    Fuzhou, Fujian

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou

  • Hainan Provincial People's Hospital

    Haikou, Hainan, 570311

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Anhui Chest Hospital

    Hefei, Anhui

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • Huzhou Central Hospital Affiliated to Zhejiang University School of Medicine

    Huzhou, Zhejiang

  • Affiliated Hospital of Jiaxing University

    Jiaxing, Zhejiang

  • The Second Affiliated Hospital of Jiaxing University

    Jiaxing

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong

  • Qilu Hospital, Shandong University

    Jinan, Shangdong

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu

  • The Sixth People's Hospital of Nantong

    Nantong, Jiangsu

  • Medical Service Community of People's Hospital of Fenghua

    Ningbo, Zhejiang

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang

  • Tsingtao Municipal Hospital, Qingdao Hospital of University Health And Rehabilitation Sciences

    Qingdao, Shandong

  • Ruijin Hospital, Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200025

  • Tongji Hospital, School of Medicine, Tongji University; Shanghai Pulmonary Hospital, School of Medicine, Tongji University; Huadong Hospital, School of Medicine, Fudan University

    Shanghai, Shanghai Municipality, 200065; 200433; 200040

  • Shanghai Fifth People's Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200245

  • Baoshan Hospital, Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality

  • Putuo People's Hospital, School of Medicine, Tongji University

    Shanghai, Shanghai Municipality

  • Shanghai General Hospital, Shanghai Jiaotong University

    Shanghai, Shanghai Municipality

  • Songjiang Hospital, Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality

  • The Eighth People's Hospital of Shanghai

    Shanghai, Shanghai Municipality

  • Yangpu Hospital, Tongji University

    Shanghai, Shanghai Municipality

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality

  • Shanghai Sixth People's Hospital, Shanghai Jiao Tong University

    Shanghai

  • The Shangrao People's Hospital

    Shangrao, Jiangxi

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • Shenzhen Institute of Respiratory Diseases

    Shenzhen, Guangdong

  • The Eighth Affiliated Hospital of Sun Yat-Sen University

    Shenzhen, Guangdong

  • Suzhou Hospital, Affiliated Hospital of Medical School, Nanjing University

    Suzhou, Jiangsu

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

  • The First Affliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

  • Zhengzhou People's Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Efficacy and Safety of tobRamycin Inhalation Solution for Pseudomonas AeruginoSa Eradication in Bronchiectasis (ERASE): a Multi-center, 2×2 Factorial Randomized, Double-blind, Placebo-controlled Trial

People with bronchiectasis are prone to Pseudomonas aeruginosa (PA) infections, which can become chronic and lead to increased death rates and disease severity. Studies from cystic fibrosis suggest that eradication therapy aimed at PA can successfully transition patients to a culture-negative status, providing long-term benefits. Current guidelines for managing bronchiectasis in adults recommend eradicating PA when it is first or newly isolated; however, there is a lack of randomized controlled trials supporting such recommendations. The researchers hypothesize that both oral ciprofloxacin combined with tobramycin inhalation solution and tobramycin inhalation solution alone are superior to no eradication (inhaled saline) in terms of the eradication rate of PA (with eradication defined as negative sputum culture results on two consecutive occasions separated by an interval of 12 weeks or more after the first drug administration).

Read the detailed description

The presence of Pseudomonas aeruginosa (PA) in bronchiectasis patients is associated with a greater impairment in lung function, increased systemic and airway inflammation, more frequent exacerbations, decreased quality of life, a higher risk of hospitalization, and increased mortality. Current guidelines recommend eradicating PA when it is first isolated, but there is limited randomized controlled trial evidence to support this.

In cystic fibrosis, early infection with PA is clearly linked to worse outcomes, and eradication is associated with clinical benefits, including improved lung function and reduced hospitalization. Small sample observational studies have shown that eradication therapy following initial PA isolation is efficient, with eradication rates of 40%-57% in bronchiectasis. Therefore, a randomized control trial of PA eradication therapy is needed to determine the microbiological and clinical outcomes of this therapy.

There is also uncertainty about whether inhaled antibiotics alone are sufficient to eradicate PA in non-cystic fibrosis bronchiectasis, given the less severe nature of the disease compared to cystic fibrosis. It's unclear whether adding another antibiotic, such as oral ciprofloxacin in this study, to inhaled antibiotics at the initial stage is necessary as an enhanced treatment for eradicating PA in bronchiectasis.

To address these knowledge gaps, a multicenter, 2×2 factorial randomized, double-blind, placebo-controlled, parallel-group study is designed in bronchiectasis patients with newly or firstly isolated PA. This study aims to investigate the efficacy and safety of tobramycin inhalation solution alone or in combination with oral ciprofloxacin in eradicating PA in bronchiectasis.

Patients will be randomly assigned to one of four groups:

  1. Placebo group: participants will receive inhaled saline twice daily for 12 weeks and an oral ciprofloxacin placebo twice daily for 2 weeks.
  2. Oral ciprofloxacin alone group: participants will receive 750mg of oral ciprofloxacin twice daily for 2 weeks and inhaled saline twice daily for 12 weeks.
  3. Tobramycin inhalation solution alone group: participants will receive 300mg of inhaled tobramycin twice daily for 12 weeks and an oral ciprofloxacin placebo twice daily for 2 weeks.
  4. Combination group: participants will receive 300mg of inhaled tobramycin solution twice daily for 12 weeks and 750mg of oral ciprofloxacin twice daily for 2 weeks.

This study will provide valuable insights into the most effective treatment strategy for eradicating PA in bronchiectasis patients.

Being tested
Tobramycin Inhalant Product, Ciprofloxacin 750 MG, Oral ciprofloxacin placebo, Natural saline inhalation
Keywords
bronchiectasis,, Pseudomonas Aeruginosa, eradication, inhaled antibiotics, randomized controlled trial
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

    Also called Inhaled antibiotics

    Tobramycin will be nebulized (300mg twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.

  • Ciprofloxacin 750 MGDrug

    Also called Oral antibiotics

    Oral ciprofloxacin 750mg twice daily will be prescribed for 2 weeks.

  • Oral ciprofloxacin placeboDrug

    Also called Oral antibiotics

    Oral ciprofloxacin placebo twice daily will be prescribed for 2 weeks.

  • Natural saline inhalationDrug

    Also called Inhaled saline

    Natural saline will be nebulized (5ml twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.

Study groups in NCT06093191
Study groupRoleWhat they receive
Combination groupActive comparatorParticipants will receive inhaled 300mg of tobramycin solution twice daily for 12 weeks and oral 750mg of ciprofloxacin twice daily for 2 weeks
Receives: Drug: Tobramycin Inhalant Product; Drug: Ciprofloxacin 750 MG
Tobramycin inhalation solution alone groupActive comparatorParticipants will receive inhaled 300mg of tobramycin twice daily for 12 weeks and oral ciprofloxacin placebo twice daily for 2 weeks
Receives: Drug: Tobramycin Inhalant Product; Drug: Oral ciprofloxacin placebo
Oral ciprofloxacin alone groupActive comparatorParticipants will receive oral 750mg of ciprofloxacin twice daily for 2 weeks and inhaled saline twice daily for 12 weeks
Receives: Drug: Ciprofloxacin 750 MG; Drug: Natural saline inhalation
Placebo groupPlacebo comparatorParticipants will receive inhaled saline twice daily for 12 weeks and oral ciprofloxacin placebo twice daily for 2 weeks
Receives: Drug: Oral ciprofloxacin placebo; Drug: Natural saline inhalation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of subjects with sustained negative sputum cultures for Pseudomonas aeruginosa (defined as negative sputum culture results on two consecutive occasions separated by an interval of 12 weeks or more) after first drug administration.

    The proportion of subjects with sustained negative sputum cultures for Pseudomonas aeruginosa after first drug administration. This is defined as negative sputum culture results on two consecutive occasions separated by an interval of 12 weeks or more.

    Measured: 36 weeks

Secondary outcomes (20)

  1. Proportion of patients with a negative Pseudomonas aeruginosa sputum culture at 12 weeks after the first drug administration.

    Proportion of patients with a negative Pseudomonas aeruginosa sputum culture at 12 weeks after the first drug administration.

    Measured: 12 weeks

  2. Proportion of patients with a negative Pseudomonas aeruginosa sputum culture at 24 weeks after the first drug administration.

    Proportion of patients with a negative Pseudomonas aeruginosa sputum culture at 24 weeks after the first drug administration.

    Measured: 24 weeks

  3. Proportion of patients with a negative Pseudomonas aeruginosa sputum culture at 36 weeks after the first drug administration.

    Proportion of patients with a negative Pseudomonas aeruginosa sputum culture at 36 weeks after the first drug administration.

    Measured: 36 weeks

  4. Time to first pulmonary exacerbation of bronchiectasis after the first drug administration.

    Time to first pulmonary exacerbation of bronchiectasis after the first drug administration.

    Measured: 36 weeks

  5. Frequency of pulmonary exacerbations of bronchiectasis after the first drug administration.

    Frequency of pulmonary exacerbations of bronchiectasis after the first drug administration.

    Measured: 12 weeks

  6. Frequency of pulmonary exacerbations of bronchiectasis after the first drug administration.

    Frequency of pulmonary exacerbations of bronchiectasis after the first drug administration.

    Measured: 36 weeks

  7. Time to reoccurrence of Pseudomonas aeruginosa infection since randomization.

    Time to reoccurrence of Pseudomonas aeruginosa infection since randomization.

    Measured: 36 weeks

  8. Absolute change from baseline in 1 second [FEV1] at 12, 24, and 36 weeks.

    Absolute change from baseline in 1 second [FEV1] at 12, 24, and 36 weeks.

    Measured: Assessed at 12 weeks, 24 weeks and 36 weeks after the first drug administration.

  9. Absolute change from baseline in forced vital capacity [FVC] at 12, 24, and 36 weeks

    Absolute change from baseline in forced vital capacity [FVC] at 12, 24, and 36 weeks

    Measured: Assessed at 12 weeks, 24 weeks and 36 weeks after the first drug administration.

  10. Absolute change from baseline in forced expiratory flow between 25 and 75% of forced vital capacity [FEF25%-75%] at 12, 24, and 36 weeks.

    Absolute change from baseline in forced expiratory flow between 25 and 75% of forced vital capacity [FEF25%-75%] at 12, 24, and 36 weeks.

    Measured: Assessed at 12 weeks, 24 weeks and 36 weeks after the first drug administration.

  11. Proportion of hospitalisations due to bronchiectasis after the first drug administration.

    Proportion of hospitalisations due to bronchiectasis after the first drug administration.

    Measured: 24 weeks

  12. Proportion of hospitalisations due to bronchiectasis after the first drug administration.

    Proportion of hospitalisations due to bronchiectasis after the first drug administration.

    Measured: 36 weeks

  13. Absolute change from baseline in health-related quality of life, as measured by the Quality-of-Life Bronchiectasis Respiratory Symptom Scale (QOL-B-RSS) score at 12, 24, and 36 weeks.

    The Quality-of-Life-Bronchiectasis (QoL-B) questionnaire is a disease-specific survey designed for patients with bronchiectasis. The Respiratory Symptoms scale is a component of the QoL-B questionnaire, with a scale range from 0 to 100. Higher scores on this scale signify a better health status.

    Measured: Assessed at 12 weeks, 24 weeks and 36 weeks after the first drug administration.

  14. Absolute change from baseline in health-related quality of life, as measured by the St George's Respiratory Questionnaire (SGRQ) score at 12, 24, and 36 weeks.

    St.George Respiratory Questionnaire (SGRQ): a validated questionnaire for use in bronchiectasis population. This questionnaire is structured into 3 main components: symptoms, activity and impacts.

    Scale range is 0-100, where lower scores correspond to the better health status.

    Each questionnaire response has a unique empirically derived "weight".

    Each component of the questionnaire is scored separately in three steps:

    1. The weights for all items with a positive responses are summed. ii. The weights for missed items are deducted from the maximum possible weight for each component. The weights for all missed items are deducted from the maximum possible weight for the Total score. iii. The score is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage The Total score is calculated in similar way.

    Measured: Assessed at 12 weeks, 24 weeks and 36 weeks after the first drug administration.

  15. Absolute change from baseline in health-related quality of life, as measured by the EuroQol Five Dimensions Questionnaire (EQ-5D-5L) score at 12, 24, and 36 weeks.

    The Euroqual-5 Dimensions questionnaire (EQ-5D) consists of two parts: health state description and evaluation. In the description part, health status is measured across five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents rate their severity level for each dimension using a five-level (EQ-5D-5L) scale.

    In the evaluation part, respondents assess their overall health status using the visual analogue scale (EQ-VAS), which ranges from 0 to 100, with higher scores indicating a better health status.

    Health states defined by the EQ-5D-5L descriptive system are converted into index values. This facilitates the calculation of Quality-Adjusted Life Years (QALYs), which are used to inform economic evaluations of healthcare interventions, according to guidelines found at https://euroqol.org.

    Measured: Assessed at 12 weeks, 24 weeks and 36 weeks after the first drug administration.

  16. Number of hospitalisations per person.

    Number of hospitalisations per person.

    Measured: 36 weeks.

  17. Cost per hospitalisation per person.

    Cost per hospitalisation per person.

    Measured: 36 weeks

  18. Isolation rate of other pathogenic microorganisms at 12 weeks, 24 weeks, and 36 weeks.

    The number of participants who yielded at least one positive culture for other pathogenic microorganisms was calculated.

    Measured: Assessed at 12 weeks, 24 weeks and 36 weeks after the first drug administration.

  19. Proportion of subjects developing resistance to tobramycin or ciprofloxacin after enrolment.

    Sputum cultures were performed at intervals of baseline, 2 weeks, 8 weeks, 12 weeks, 24 weeks, and 36 weeks. Drug sensitivity testing was conducted to assess the resistance of the current Pseudomonas aeruginosa sample to antibiotics such as ciprofloxacin and tobramycin. The number of participants who showed growth of Pseudomonas aeruginosa resistant to ciprofloxacin and/or tobramycin was calculated.

    Measured: 36 weeks

  20. Incidence of adverse events and serious adverse events.

    Assessed by the investigator via patient interview, spontaneous reporting, and clinical evaluation.

    Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start18 Oct 2023
  3. Primary completion28 Oct 2025
  4. Study completion15 Nov 2025

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized into one of the four groups. No cross-over of the study group will be made
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
371 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06093191
Sponsor's protocol ID
20230329
Acronym
ERASE
Status last verified
Apr 2026
First submitted
10 Oct 2023
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Polverino E, Goeminne PC, McDonnell MJ, Aliberti S, Marshall SE, Loebinger MR, Murris M, Canton R, Torres A, Dimakou K, De Soyza A, Hill AT, Haworth CS, Vendrell M, Ringshausen FC, Subotic D, Wilson R, Vilaro J, Stallberg B, Welte T, Rohde G, Blasi F, Elborn S, Almagro M, Timothy A, Ruddy T, Tonia T, Rigau D, Chalmers JD. European Respiratory Society guidelines for the management of adult bronchiectasis. Eur Respir J. 2017 Sep 9;50(3):1700629. doi: 10.1183/13993003.00629-2017. Print 2017 Sep.

    PubMed 28889110

  • Hill AT, Sullivan AL, Chalmers JD, De Soyza A, Elborn SJ, Floto AR, Grillo L, Gruffydd-Jones K, Harvey A, Haworth CS, Hiscocks E, Hurst JR, Johnson C, Kelleher PW, Bedi P, Payne K, Saleh H, Screaton NJ, Smith M, Tunney M, Whitters D, Wilson R, Loebinger MR. British Thoracic Society Guideline for bronchiectasis in adults. Thorax. 2019 Jan;74(Suppl 1):1-69. doi: 10.1136/thoraxjnl-2018-212463. No abstract available.

    PubMed 30545985

  • Aliberti S, Masefield S, Polverino E, De Soyza A, Loebinger MR, Menendez R, Ringshausen FC, Vendrell M, Powell P, Chalmers JD; EMBARC Study Group. Research priorities in bronchiectasis: a consensus statement from the EMBARC Clinical Research Collaboration. Eur Respir J. 2016 Sep;48(3):632-47. doi: 10.1183/13993003.01888-2015. Epub 2016 Jun 10.

    PubMed 27288031

  • White L, Mirrani G, Grover M, Rollason J, Malin A, Suntharalingam J. Outcomes of Pseudomonas eradication therapy in patients with non-cystic fibrosis bronchiectasis. Respir Med. 2012 Mar;106(3):356-60. doi: 10.1016/j.rmed.2011.11.018. Epub 2011 Dec 26.

    PubMed 22204744

  • Vallieres E, Tumelty K, Tunney MM, Hannah R, Hewitt O, Elborn JS, Downey DG. Efficacy of Pseudomonas aeruginosa eradication regimens in bronchiectasis. Eur Respir J. 2017 Apr 12;49(4):1600851. doi: 10.1183/13993003.00851-2016. Print 2017 Apr. No abstract available.

    PubMed 28404646

  • Blanco-Aparicio M, Saleta Canosa JL, Valino Lopez P, Martin Egana MT, Vidal Garcia I, Montero Martinez C. Eradication of Pseudomonas aeruginosa with inhaled colistin in adults with non-cystic fibrosis bronchiectasis. Chron Respir Dis. 2019 Jan-Dec;16:1479973119872513. doi: 10.1177/1479973119872513.

    PubMed 31480862

  • Orriols 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 26340658

  • Pieters A, Bakker M, Hoek RAS, Altenburg J, van Westreenen M, Aerts JGJV, van der Eerden MM. The clinical impact of Pseudomonas aeruginosa eradication in bronchiectasis in a Dutch referral centre. Eur Respir J. 2019 Apr 11;53(4):1802081. doi: 10.1183/13993003.02081-2018. Print 2019 Apr. No abstract available.

    PubMed 30635292

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tobramycin Inhalant Product, Ciprofloxacin 750 MG and Natural saline inhalation in people with Bronchiectasis Adult and Pseudomonas Aeruginosa Infection, run by Jin-Fu Xu at 60 sites 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 10 inclusion and 14 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: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of subjects with sustained negative sputum cultures for Pseudomonas aeruginosa (defined as negative sputum culture results on two consecutive occasions separated by an interval of 12 weeks or more) after first drug administration. (time frame: 36 weeks). 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 NCT06093191, which also lists 8 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 17 Apr 2026.

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