Long Term Nebulised Gentamicin in Patients With Bronchiectasis

checkorphan
Learn more about:
Bronchiectasis
Related Clinical Trial
COVID-19 Phobia in Patients With Bronchiectasis During Covid-19 Pandemic Identification of Microbiome of Bronchiectasis in Chinese Population. Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19) Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound COPD Patient-Powered Research Network Can we Reduce Hospital Attendance Without Compromising Care by the Use of Telephone Consultation Sustained Effects of Hypertonic Saline on Mucociliary Clearance in Subjects With Chronic Bronchitis Seoul National University Airway Registry VX-770 for the Treatment of Chronic Bronchitis Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis Adherence to Airway Clearance. Novel Approaches to Improving Adherence Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects Prevalence of Respiratory Impairment During IBD The SENSOR Study: A Mixed-methods Study of SElf-management Checks to Predict exacerbatioNs of Pseudomonas Aeruginosa in Patients With Long-term reSpiratORy Conditions The Effect of Proprioceptive Neuromuscular Facilitation (PNF) Technique for Children With Chronic Pulmonary Diseases. Effect of HFCWO Vests on Spirometry Measurements Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements Epidemiology and Diagnosis of Haemoptysis: a Multicenter Study Evaluating the Effects of Traditional Chinese Medicine by N-of-1 Trials A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Food Effect of Single or Repeat Doses of GSK2793660 in Healthy Subjects Biological Determinants of Sputum Rheology in Chronic Airway Diseases A Pilot Study to Investigate Administration of Mannitol Via a Novel Dry Powder Inhaler Device Efficacy and Safety Study of a Percussion Device to Mobilise Sputum From Respiratory Passage ATP and Capsaicin Cough Provocation Test in Chronic Cough and Bronchiectasis Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo Lung Clearance Index (LCI) in Pediatric Patients With Obstructive Lung Disease The Prevalence of Gastro-oesophageal Reflux in Chronic Lung Disease High Dose Inhaled Mannitol Study Macrolide Mediates Pulmonary Infection of Pseudomonas Aeruginosa Respiratory Muscle Strength in Bronchiectasis: Repeatability and Reliability Longitudinal Study of Helium-3 and Xenon-129 Magnetic Resonance Imaging The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) Evaluation Of The Lung Microbiome In NTM Bronchiectasis Inhalation Flow Rate-study Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis Inspiratory Flow and Volumes in Bronchiectatics Evaluation of Oscillatory Positive Expiratory Pressure (oPEP) in Bronchiectasis and COPD Evaluation of Periodontal Treatment in Patients With Bronchiectasis Long Term Nebulised Gentamicin in Patients With Bronchiectasis Comparison of PR Efficiency in Home-based With Hospital-based PR in Bronchiectasis Safety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis. Study of the Effect of FLUTTER® VRP1 (PEP and Oscillating High Frequency). Comparisons of Inhaled LAMA or LAMA+LABA or ICS+LABA for COPD With Bronchiectasis A Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis Effects of Chest Physiotherapy (CPT) on Lung Clearance Index (LCI) in Non Cystic Fibrosis (CF) Bronchiectasis Randomised Open Label Trial of Hypertonic Saline and Carbocisteine in Bronchiectasis (CLEAR) Tobramycin in Bronchiectasis Colonized With Pseudmonas Aeruginosa Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis Physiological Effects of Expiration With the Glottis Open in Lateral Posture (ELTGOL) and Flutter Valve in Patients With Bronchiectasis Comparison of the Efficacy of Comprehensive Respiratory Physiotherapy in Children With Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa. Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non Cystic Fibrosis Bronchiectasis Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis Safety and Efficacy of Bronchitol in Bronchiectasis Predictors of Physical Activity Performance and Dynamic Hyperinflation in Patients With Bronchiectasis Oscillating PEP vs Autogenic Drainage in People With Bronchiectasis Feasibility of Interval Exercise in Bronchiectasis Prognosis of Bronchiectasis in Children–A Multicenter Prospective Cohort Study Exercise Training in Patients With Non-cystic Fibrosis (CF) Bronchiectasis Effects of Inspiratory Muscle Training in Patients With Bronchiectasis Acute Effects of a Flutter Device and Chest Wall Compression on Respiratory System Impedance in Bronchiectasis Patients Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis Cardiovascular Comorbidities and Bronchiectasis The Effect of Different Virtual Reality-Based Exercise Trainings on Pulmonary Function, Respiratory and Peripheral Muscle Strength, Functional Capacity and Balance in Children With Bronchiectasis Functional Respiratory Imaging in Bronchiectasis Safety and Potential Efficacy of Human Mesenchymal Stem Cells in Non‐Cystic Fibrosis Bronchiectasis Long-term Prognosis of Children With Bronchiectasis Treated With Low-dose Erythromycin Intervention Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis Feasibility Study of the AffloVest in Bronchiectasis Atorvastatin in Bronchiectasis in Patients With Pseudomonas Aeruginosa The Effect of Theophylline in the Treatment of Bronchiectasis Bronchiectasis and Long Term Azithromycin Treatment Clinimetric Properties of Outcome Measures in Bronchiectasis in the UK Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) Pain Mechanisms in Patients With Bronchiectasis Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis Bronchoalveolar Lavage for Bronchiectasis Patients With Exacerbation Efficacy of Azithromycin in Treatment of Bronchiectasis Airway Clearance in Bronchiectasis: is Non-Invasive Ventilation a Useful Adjunct in Moderate to Severe Disease? Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With Bronchiectasis Efficacy of Budesonide-Formoterol in Bronchiectasis Exhaled Breath Condensate Assessment in Stable Non-Cystic Fibrotic Bronchiectasis Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) Long-term Airway Clearance Therapy in Non-cystic Fibrosis Bronchiectasis Bacterial Load Guided Therapy for Severe Bronchiectasis Exacerbations Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QBW251 in Subjects With Bronchiectasis Mucus Solids Concentration in Patients With Bronchiectasis Target Validation and Discovery in Idiopathic Bronchiectasis Exercise Capacity in Bronchiectasis Resection Physical Activity in Bronchiectasis The Role of Theophylline Plus Low-dose Formoterol-budesonide in Treatment of Bronchiectasis Effect of AIRVO Heated Humidification in Bronchiectasis A Safety Trial of DAS181 (Fludase®) in Adult Subjects With Well-Controlled Asthma or Bronchiectasis A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis Lung Dispersing, Turbid Descending and Gut Clearing Decoction for Bronchiectasis Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis? Pulmonary Rehabilitation Program (PRP) Versus PRP Plus Nutritional Supplementation in Patients With Bronchiectasis Autologous Transplantation of Bronchial Basal Cells for Treatment of Bronchiectasis Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis: A Randomized, Multi-center, Double-blind Study Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Bronchiectasis Effects of High Intensity Inspiratory Muscle Training on Exercise Capacity in Patients With Bronchiectasis Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis Impact of Chronic Air Pollution on Non-cystic Fibrosis Bronchiectasis Comparison of Physical Activity Level Between Patients With Bronchiectasis and Healthy Subjects Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Bronchiectasis Evaluation of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) in Patients With Bronchiectasis The Effect of Bronchiectasis on the Exacerbation and Mortality in COPD Inhaled A1AT in Adult Stable Bronchiectasis Prevention of Bronchiectasis in Infants With Cystic Fibrosis Pulmonary Rehabilitation in Non-Cystic Fibrosis Bronchiectasis Metabolomic Analysis of Exhaled Breath Condensates in Patients With COPD and Bronchiectasis Physical Capacity in Patients With Bronchiectasis Before and After Rehabilitation Program In-exsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis Bronchiectasis Effect in COPD Patients Prevalence and Characteristics of Patients With Bronchiectasis Comorbid Nontuberculous Mycobacteria Aetiology of Children With Bronchiectasis in China Macrolides in COPD- Bronchiectasis Overlap Value of Inhaled Treatment With Aztreonam Lysine in Bronchiectasis Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis Bronchiectasis Comparison of Sit-to-stand Test With Six-minute Walk Test in Bronchiectasis and Healthy Children Characterization of Airway Mucus in Bronchiectasis Patients and Healthy Controls The PROspective German NOn-CF bronchiectaSIS Patient Registry The BRIDGE Study – Bronchiectasis Research Involving Databases, Genomics and Endotyping Role of Innate Immunity in Non-Cystic Fibrosis Bronchiectasis Exercise Capacity in Patients With Cystic Fibrosis vs. Non-cystic Fibrosis Bronchiectasis Evaluation of Medical and Nursing Management for Bronchiectasis A Pilot Study to Evaluate the Use of the Vest® System for Treatment of Bronchiectasis Patients in the Home Setting The Establishment of China Bronchiectasis Registry and Research Collaboration Short-and Long-term Effects of a Home-based Rehabilitation Program in Patients With Bronchiectasis The Role of Viral Infection in Acute Exacerbations of Non-cystic Fibrosis Bronchiectasis in Adults Bronchiectasis: Evaluation of an Educational Intervention Prevalence of Bronchiectasis in COPD Patients ELTGOL and Bronchiectasis. Respiratory Therapy Bacteriology and Inflammation in Bronchiectasis Different Phenotypes of Bronchiectasis Effects of Traditional Chinese Medicine on Bronchiectasis Patients The Prevalence and Impact of Depression and Anxiety Symptoms in Patients With Non-CF Bronchiectasis

Brief Title

Long Term Nebulised Gentamicin in Patients With Bronchiectasis

Official Title

Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis

Brief Summary

      The hypothesis of this randomized placebo controlled trial is that targeted nebulized
      gentamicin to the airways will reduce bacterial burden and limit neutrophil airways
      inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise
      capacity and health related quality of life with a reduction in exacerbation frequency and
      health care utilization.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Reduction in bacterial load

Secondary Outcome

 airways and systemic inflammation

Condition

Bronchiectasis

Intervention

Gentamicin

Study Arms / Comparison Groups

 1
Description:  Nebulised Gentamicin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

60

Start Date

May 2007

Completion Date

August 2009

Primary Completion Date

August 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Bronchiectasis confirmed by HRCT of the chest

          -  Clinically stable (not requiring antibiotics for at least 4 weeks preceding the study
             start date)

          -  Aged 18-70

          -  Chronic sputum production > 5 mls for the majority of days in 3 months before
             enrolment

          -  Chronically colonized (on at least 2 occasions in the preceding 12 months) whilst
             clinically stable

          -  At least two exacerbations in the past year

          -  Patients able to tolerate a nebulized gentamicin challenge

          -  FEV1 > 30% predicted

          -  Smoking < 20 pack year history and ex-smokers >1 year.

        Exclusion Criteria:

          -  Cystic fibrosis

          -  Emphysema on HRCT chest

          -  Thoracic surgery within the past 1 year

          -  Allergic bronchopulmonary aspergillosis

          -  Poorly controlled asthma ( > 20% diurnal variation in peak expiratory flows despite
             treatment)

          -  Unstable angina or uncontrolled congestive cardiac failure

          -  Active malignancy

          -  Pregnancy or breast feeding

          -  Creatinine clearance < 30 mls/minute

          -  Vestibular instability

          -  Previous documented intolerance to aminoglycosides

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Adam T Hill, MBChB MD, ,

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations

NCT ID

NCT00749866

Organization ID

CZB/4/451

Study Sponsor

University of Edinburgh

Collaborators

 NHS Lothian

Study Sponsor

Adam T Hill, MBChB MD, Principal Investigator, NHS Lothian and University of Edinburgh

Verification Date

August 2010