Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Bronchiectasis (ERASE)

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).

Study Overview

• Status: Completed
• Conditions: Bronchiectasis Adult; Pseudomonas Aeruginosa Infection
• Intervention / Treatment: Drug: Tobramycin Inhalant Product; Drug: Ciprofloxacin 750 MG; Drug: Oral ciprofloxacin placebo; Drug: Natural saline inhalation

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.

• Study Type: Interventional
• Enrollment (Actual): 371
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiaxing, China
    • The Second Affiliated Hospital of Jiaxing University
  • Shanghai, China
    • Shanghai Sixth People's Hospital, Shanghai Jiao Tong University
  • Anhui
    • Hefei, Anhui, China
      • The First Affiliated Hospital of Anhui Medical University
    • Hefei, Anhui, China
      • Anhui Chest Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Peking Union Medical College Hospital
    • Beijing, Beijing Municipality, China
      • Beijing Chao-Yang Hospital, Capital Medical University
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • The Second Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing Municipality, China
      • The Third Affiliated Hospital of Chongqing Medical University
  • Fujian
    • Fuzhou, Fujian, China
      • Fujian Provincial Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
    • Shenzhen, Guangdong, China
      • Shenzhen Institute of Respiratory Diseases
    • Shenzhen, Guangdong, China
      • The Eighth Affiliated Hospital of Sun Yat-Sen University
    • Zhanjiang, Guangdong, China
      • Affiliated Hospital of Guangdong Medical University
  • Guangxi
    • Nanning, Guangxi, China
      • The First Affiliated Hospital of Guangxi Medical University
  • Guizhou
    • Guiyang, Guizhou, China
      • Guizhou Provincial People's Hospital
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan Provincial People's Hospital
  • Henan
    • Zhengzhou, Henan, China
      • Henan Provincial People's Hospital
    • Zhengzhou, Henan, China
      • Zhengzhou People's Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • The Second Xiangya Hospital Of Central South University
    • Changsha, Hunan, China
      • Xiangya Hospital, Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China
      • The Second Affiliated Hospital of Nanjing Medical University
    • Nantong, Jiangsu, China
      • Affiliated Hospital of Nantong University
    • Nantong, Jiangsu, China
      • The Sixth People's Hospital of Nantong
    • Suzhou, Jiangsu, China
      • The First Affiliated Hospital of Soochow University
    • Suzhou, Jiangsu, China
      • Suzhou Hospital, Affiliated Hospital of Medical School, Nanjing University
    • Yangzhou, Jiangsu, China
      • Northern Jiangsu People's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The First Affiliated Hospital of Nanchang University
    • Shangrao, Jiangxi, China
      • The Shangrao People's Hospital
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China
      • The Second Affiliated Hospital of Dalian Medical University
    • Shenyang, Liaoning, China
      • Shengjing Hospital of China Medical University
    • Shenyang, Liaoning, China
      • The First Hospital of China Medical University
  • Shandong
    • Jinan, Shandong, China
      • The First Affiliated Hospital of Shandong First Medical University
    • Qingdao, Shandong, China
      • Tsingtao Municipal Hospital, Qingdao Hospital of University Health And Rehabilitation Sciences
  • Shangdong
    • Jinan, Shangdong, China
      • Qilu Hospital, Shandong University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Zhongshan Hospital, Fudan University
    • Shanghai, Shanghai Municipality, China, 200025
      • Ruijin Hospital, Shanghai Jiaotong University
    • Shanghai, Shanghai Municipality, China, 200065; 200433; 200040
      • 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, China, 200245
      • Shanghai Fifth People's Hospital, Fudan University
    • Shanghai, Shanghai Municipality, China
      • Baoshan Hospital, Shanghai University of Traditional Chinese Medicine
    • Shanghai, Shanghai Municipality, China
      • Putuo People's Hospital, School of Medicine, Tongji University
    • Shanghai, Shanghai Municipality, China
      • Shanghai General Hospital, Shanghai Jiaotong University
    • Shanghai, Shanghai Municipality, China
      • Songjiang Hospital, Shanghai Jiao Tong University
    • Shanghai, Shanghai Municipality, China
      • The Eighth People's Hospital of Shanghai
    • Shanghai, Shanghai Municipality, China
      • Yangpu Hospital, Tongji University
  • Shanxi
    • Taiyuan, Shanxi, China, 030032
      • Shanxi Bethune Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital, Sichuan University
  • Yunnan
    • Anning, Yunnan, China
      • The First People's Hospital of Anning Affiliated to Kunming University of Science and Technology
    • Kunming, Yunnan, China, 650032
      • The First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • The affiliated hospital of Hangzhou Normal University
    • Huzhou, Zhejiang, China
      • Huzhou Central Hospital Affiliated to Zhejiang University School of Medicine
    • Jiaxing, Zhejiang, China
      • Affiliated Hospital of Jiaxing University
    • Ningbo, Zhejiang, China
      • Ningbo Medical Center Lihuili Hospital
    • Ningbo, Zhejiang, China
      • The First Affiliated Hospital of Ningbo University
    • Ningbo, Zhejiang, China
      • Medical Service Community of People's Hospital of Fenghua
    • Wenzhou, Zhejiang, China
      • The First Affliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female, aged 18 years and 80 years at screening
2. Signed and dated written informed consent prior to admission to the study in accordance with local legislation.
3. 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

4. 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);

   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);

5. 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)
6. During the screening period, P. aeruginosa is not resistant to Tobramycin and Ciprofloxacin based on the drug sensitivity test of sputum culture in vitro
7. Patient can tolerate nebulized inhalation therapy

Exclusion criteria

1. Patients who are allergic to or cannot tolerate the investigational drugs (Tobramycin, Ciprofloxacin)
2. 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;
3. 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
4. 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.
5. AST and/or ALT >2 ULN and/or Total Bilirubin (TBIL) at screening period
6. Serum creatinine >ULN at screening period
7. Participants with a history of hearing loss or those who are determined by the researcher to have clinically significant chronic tinnitus
8. Participants with a history of prolonged QT intervals or those whose electrocardiograms show prolonged QT intervals during the screening period
9. Participants who have used drugs that are prohibited according to the plan during the screening period.
10. Women who are pregnant or lactating, or women of childbearing potential preparing for pregnancy
11. Patients with FEV1% of predicted value<30%
12. Participants who have participated in other clinical trials (defined as those where medication has been administered) within the 4 weeks prior to the screening
13. 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.
14. Participants who are deemed unsuitable for inclusion in the study due to other reasons, as determined by the researcher.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Combination group; Participants will receive inhaled 300mg of tobramycin solution twice daily for 12 weeks and oral 750mg of ciprofloxacin twice daily for 2 weeks	Drug: Tobramycin Inhalant Product; Tobramycin will be nebulized (300mg twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.; Other Names: Inhaled antibiotics; Drug: Ciprofloxacin 750 MG; Oral ciprofloxacin 750mg twice daily will be prescribed for 2 weeks.; Other Names: Oral antibiotics
Active Comparator: Tobramycin inhalation solution alone group; Participants will receive inhaled 300mg of tobramycin twice daily for 12 weeks and oral ciprofloxacin placebo twice daily for 2 weeks	Drug: Tobramycin Inhalant Product; Tobramycin will be nebulized (300mg twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.; Other Names: Inhaled antibiotics; Drug: Oral ciprofloxacin placebo; Oral ciprofloxacin placebo twice daily will be prescribed for 2 weeks.; Other Names: Oral antibiotics
Active Comparator: Oral ciprofloxacin alone group; Participants will receive oral 750mg of ciprofloxacin twice daily for 2 weeks and inhaled saline twice daily for 12 weeks	Drug: Ciprofloxacin 750 MG; Oral ciprofloxacin 750mg twice daily will be prescribed for 2 weeks.; Other Names: Oral antibiotics; Drug: Natural saline inhalation; Natural saline will be nebulized (5ml twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.; Other Names: Inhaled saline
Placebo Comparator: Placebo group; Participants will receive inhaled saline twice daily for 12 weeks and oral ciprofloxacin placebo twice daily for 2 weeks	Drug: Oral ciprofloxacin placebo; Oral ciprofloxacin placebo twice daily will be prescribed for 2 weeks.; Other Names: Oral antibiotics; Drug: Natural saline inhalation; Natural saline will be nebulized (5ml twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.; Other Names: Inhaled saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
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.	24 weeks
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.	36 weeks
Time to first pulmonary exacerbation of bronchiectasis after the first drug administration.	Time to first pulmonary exacerbation of bronchiectasis after the first drug administration.	36 weeks
Frequency of pulmonary exacerbations of bronchiectasis after the first drug administration.	Frequency of pulmonary exacerbations of bronchiectasis after the first drug administration.	12 weeks
Frequency of pulmonary exacerbations of bronchiectasis after the first drug administration.	Frequency of pulmonary exacerbations of bronchiectasis after the first drug administration.	36 weeks
Time to reoccurrence of Pseudomonas aeruginosa infection since randomization.	Time to reoccurrence of Pseudomonas aeruginosa infection since randomization.	36 weeks
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.	Assessed at 12 weeks, 24 weeks and 36 weeks after the first drug administration.
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	Assessed at 12 weeks, 24 weeks and 36 weeks after the first drug administration.
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.	Assessed at 12 weeks, 24 weeks and 36 weeks after the first drug administration.
Proportion of hospitalisations due to bronchiectasis after the first drug administration.	Proportion of hospitalisations due to bronchiectasis after the first drug administration.	24 weeks
Proportion of hospitalisations due to bronchiectasis after the first drug administration.	Proportion of hospitalisations due to bronchiectasis after the first drug administration.	36 weeks
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.	Assessed at 12 weeks, 24 weeks and 36 weeks after the first drug administration.
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: i. 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.	Assessed at 12 weeks, 24 weeks and 36 weeks after the first drug administration.
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.	Assessed at 12 weeks, 24 weeks and 36 weeks after the first drug administration.
Number of hospitalisations per person.	Number of hospitalisations per person.	36 weeks.
Cost per hospitalisation per person.	Cost per hospitalisation per person.	36 weeks
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.	Assessed at 12 weeks, 24 weeks and 36 weeks after the first drug administration.
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.	36 weeks
Incidence of adverse events and serious adverse events.	Assessed by the investigator via patient interview, spontaneous reporting, and clinical evaluation.	36 weeks

Collaborators and Investigators

• Sponsor: Jin-Fu Xu
• Investigators: Principal Investigator: Jin-Fu Xu, MD, PhD, Tongji Hospital, School of Medicine, Tongji University; Shanghai Pulmonary Hospital, School of Medicine, Tongji University; Huadong Hospital, School of Medicine, Fudan University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Actual): October 28, 2025
• Study Completion (Actual): November 15, 2025

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; eradication; Pseudomonas Aeruginosa; inhaled antibiotics; bronchiectasis,
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Bronchial Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Bronchiectasis; Pseudomonas Infections; Anti-Infective Agents; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Anti-Bacterial Agents; Ciprofloxacin
• Other Study ID Numbers: 20230329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No