A Double-blind Placebo-controlled Multi-centre Clinical Trial to Investigate the Efficacy and Safety of 24 Months of Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected Wi

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Bronchiectasis
  • Age: Between 18 - 99 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants who are 18 years or older
    2. Diagnosed with non–cystic fibrosis bronchiectasis (NCFB)
    3. Participants had at least 2 pulmonary exacerbations requiring oral antibiotics or 1 pulmonary exacerbation requiring intravenous antibiotics
    4. Those who have a documented history of P. aeruginosa infection
    5. Participants had 1 positive sputum culture for P. aeruginosa
    6. Those who are clinically stable and have not required a change in pulmonary treatment
    7. Have pre-bronchodilator FEV =30% of predicted

You may not be eligible for this study if the following are true:

    1. Known bronchiectasis as a consequence of cystic fibrosis (CF)
    2. known history of hypogammaglobulinaemia requiring treatment with immunoglobulin, unless fully replaced and considered immuno-competent by the Investigator
    3. Those who have myasthenia gravis or porphyria;
    4. Severe cardiovascular disease
    5. had major surgery in the 3 months
    6. receiving treatment for ABPA
    7. had massive haemoptysis
    8. respiratory failure that would compromise patient safety or confound the evaluation of safety or efficacy of the study in the opinion of the Investigator
    9. current active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin without metastases
    10. taking immunosuppressive medications
    11. known history of human immunodeficiency virus (HIV)
    12. current treatment for non-tuberculous mycobacterial (NTM) lung disease or tuberculosis;
    13. known or suspected to be allergic or unable to tolerate colistimethate sodium (intravenous or inhaled) or other polymixins
    14. treatment with long term (= 30 days) prednisone at a dose of greater than 15 mg a day
    15. new maintenance treatment with any oral macrolides
    16. use of any intravenous or intramuscular or oral or inhaled anti-pseudomonal antibiotics
    17. Pregnant or lactating
    18. Significant abnormality in clinical evaluations and/or laboratory tests
    19. Participated in another investigational, interventional trial



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