A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)
- Conditions
- subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosanon-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa10004018
- Registration Number
- NL-OMON48850
- Lead Sponsor
- Zambon SpA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Subjects can be included in the trial if they meet all the inclusion criteria
listed below:, 1. are able and willing to give informed consent following a
detailed explanation of participation in the protocol and signed consent
obtained;
2. are aged 18 years or older of either gender;
3. diagnosed with NCFB by computerised tomography (CT) or high resolution CT
(HRCT) as recorded in the subject*s notes;
4. had at least 2 NCFB pulmonary exacerbations requiring oral antibiotics or 1
NCFB pulmonary exacerbation requiring intravenous antibiotics in the 12 months
preceding the Screening Visit (Visit 1) and had no NCFB pulmonary exacerbation
with or without treatment during the period between Visit 1 and Visit 2;
5. have a documented history of P. aeruginosa infection;
6. are clinically stable and have not required a change in pulmonary treatment
for at least 30 days before the Screening Visit (Visit 1);
7. have pre-bronchodilator FEV1 *30% of predicted;
8. had a positive sputum culture for P. aeruginosa from an adequate sample
taken at the Screening Visit (Visit 1).
Subjects are not eligible for the trial if they meet one or more of the
exclusion criteria listed below:, 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. myasthenia gravis, porphyria or myeloproliferative disease;
4. severe cardiovascular disease such as severe uncontrolled hypertension,
ischaemic heart disease or cardiac arrhythmia and any other conditions that
would confound the evaluation of safety, in the opinion of the Investigator;
5. had major surgery in the 3 months prior to the Screening Visit (Visit 1) or
planned inpatient major surgery during the study period;
6. receiving treatment for allergic bronchopulmonary aspergillosis (ABPA);
7. had massive haemoptysis (greater than or equal to 300 mL or requiring blood
transfusion) in the preceding 4 weeks before the Screening Visit (Visit 1) or
between Visit 1 and Visit 2;
8. predominant lung condition being chronic obstructive pulmonary disease
(COPD), asthma or interstitial lung disease in the opinion of the Investigator;
9. respiratory failure requiring long-term domiciliary oxygen therapy or
non-invasive ventilation;
10. current active malignancy, except for basal cell carcinoma of the skin
without metastases;
11. taking immunosuppressive medications (such as azathioprine, methotrexate,
cyclosporine, tacrolimus, sirolimus, mycophenolate, rituximab), and/or
anti-cytokine medications (such as anti-IL-6 and anti-tumour alpha necrosis
factor products) in the preceding year before the Screening Visit (Visit 1);
12. known history of human immunodeficiency virus (HIV);
13. current diagnosis or current treatment for non-tuberculous mycobacterial
(NTM) pulmonary disease or Mycobacterium tuberculosis infection;
14. known to be intolerant to inhaled beta-2 agonists (bronchodilators);
15. known or suspected to be allergic or unable to tolerate colistimethate
sodium (intravenous or inhaled) or other polymixins, including previous
evidence of bronchial hyperreactivity following inhaled colistimethate sodium;
16. treatment with long term (* 30 days) prednisone at a dose greater than 15
mg a day (or equivalent dose of any other corticosteroid) within 6 months of
the Screening Visit 1 (Visit 1);
17. new maintenance treatment with oral macrolides (e.g.
azithromycin/erythromycin/clarithromycin) started within 30 days of the
Screening Visit (Visit 1) or started between Visit 1 and Visit 2;
18. use of any intravenous or intramuscular or oral or inhaled anti-pseudomonal
antibiotic (except chronic oral macrolide treatment with a stable dose) within
30 days prior to the Screening Visit (Visit 1) and between Visit 1 and Visit 2;
19. pregnant or breast feeding or plan to become pregnant over the next year or
of child-bearing potential and unwilling to use a reliable method of
contraception for at least one month before randomisation and throughout their
involvement in the trial;
20. significant abnormality in clinical evaluations and/or laboratory tests
(physical examination, vital signs, haematology, clinical chemistry, clinically
relevant impaired renal function, defined as serum creatinine levels *2.0x
upper limit of normal, ECG) endangering the
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Efficacy Variable:<br /><br>Mean annual pulmonary exacerbation rate.</p><br>
- Secondary Outcome Measures
Name Time Method