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:
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Conditions: Bronchiectasis
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Age: Between 18 years - 99 years
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Gender: Male or Female
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Other Inclusion Criteria:
- Participants who are 18 years or older
- Diagnosed with non–cystic fibrosis bronchiectasis (NCFB)
- Participants had at least 2 pulmonary exacerbations requiring oral antibiotics or 1 pulmonary exacerbation requiring intravenous antibiotics
- Those who have a documented history of P. aeruginosa infection
- Participants had 1 positive sputum culture for P. aeruginosa
- Those who are clinically stable and have not required a change in pulmonary treatment
- Have pre-bronchodilator FEV =30% of predicted
You may not be eligible for this study if the following are true:
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- Known bronchiectasis as a consequence of cystic fibrosis (CF)
- known history of hypogammaglobulinaemia requiring treatment with immunoglobulin, unless fully replaced and considered immuno-competent by the Investigator
- Those who have myasthenia gravis or porphyria;
- Severe cardiovascular disease
- had major surgery in the 3 months
- receiving treatment for ABPA
- had massive haemoptysis
- respiratory failure that would compromise patient safety or confound the evaluation of safety or efficacy of the study in the opinion of the Investigator
- current active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin without metastases
- taking immunosuppressive medications
- known history of human immunodeficiency virus (HIV)
- current treatment for non-tuberculous mycobacterial (NTM) lung disease or tuberculosis;
- known or suspected to be allergic or unable to tolerate colistimethate sodium (intravenous or inhaled) or other polymixins
- treatment with long term (= 30 days) prednisone at a dose of greater than 15 mg a day
- new maintenance treatment with any oral macrolides
- use of any intravenous or intramuscular or oral or inhaled anti-pseudomonal antibiotics
- Pregnant or lactating
- Significant abnormality in clinical evaluations and/or laboratory tests
- Participated in another investigational, interventional trial
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.