A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)

Phase 1

• Conditions: on-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa; MedDRA version: 19.1Level: PTClassification code 10006445Term: BronchiectasisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-002743-33-ES
• Lead Sponsor: Zambon S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-10
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

Subjects can be included in the trial if they meet all 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. Aged 18 years or older of either genders;
3. Diagnosed with non-CF bronchiectasis by computerised tomography (or high resolution CT) and recorded in the subject’s notes;
4. Had at least 2 NCFB pulmonary exacerbations requiring oral antibiotics or 1 pulmonary exacerbation requiring intravenous antibiotics in the 12 months preceding the Screening Visit (Visit 1);
5. Had 1 positive sputum culture for P. aeruginosa in the 12 months preceding the Screening Visit (but performed at least 30 days before the Screening Visit);
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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 132
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 132

Exclusion Criteria

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) or focal endobronchial lesion or otherwise curable causes (e.g. foreign body aspiration);
2. known history of hypogammaglobulinaemia requiring treatment with immunoglobulin, inflammatory bowel disease, primary ciliary dyskinesia, myasthenia gravis, porphyria or myeloproliferative disease, severe cardiovascular disease;
3. a major abdominal, chest or brain surgery in the 3 months prior to Screening Visit (Visit 1) or planned inpatient major surgery during the study period;
4. receiving treatment for allergic bronchopulmonary aspergillosis (ABPA);
5. massive haemoptysis (greater than or equal to 300 mL or requiring blood transfusion) in the preceding 4 weeks before Screening Visit (Visit 1);
6. predominant lung condition being chronic obstructive pulmonary disease (COPD) or asthma or interstitial lung disease in the opinion of the Investigator;
7. History of any of the following:
- listed for transplantation;
- any other significant active illness likely to affect the patient’s survival within 12 months;
- receiving long-term domiciliary oxygen therapy or non-invasive ventilation for the management of respiratory failure;
8. current active malignancy, except for basal cell carcinoma of the skin without metastases, history of solid organ or bone marrow transplant;
9. taking immunosuppressive medications such as azathioprine, methotrexate, ciclosporine, tacrolimus, sirolimus, mycophenolate, anti cytokine medications, rituximab;
10. known history of human immunodeficiency virus (HIV), hepatitis B or C;
11. current diagnosis of Mycobacterium tuberculosis infection;
12. positive cultures for Mycobacterium abscessus complex, or Mycobacterium avium complex, or Mycobacterium xenopi, or Mycobacterium kansasii, or Mycobacterium malmoense or Mycobacterium simiae in the year preceding the Screening Visit (Visit 1);
13. current treatment for non-tuberculous mycobacterial (NTM) pulmonary infection or be under consideration for NTM treatment in the next 12 months;
14. current smokers or ex-smokers less than 6 months prior to Screening Visit (Visit 1);
15. evidence of bronchial hyperreactivity that may, in the opinion of the Investigator, indicate such subjects will not be able to tolerate colistimethate sodium;
16. known to be intolerant to inhaled beta agonists (bronchodilators);
17. known or suspected to be allergic or unable to tolerate colistimethate sodium or other polymixins;
18. therapy with long term (= 30 days) prednisone at stable dose greater than 15 mg a day (or equivalent dose of any other corticosteroid) prior to Screening Visit 1 (Visit 1);
19. new maintenance treatment with oral macrolides (azithromycin or erythromycin) started within 30 days of the Screening Visit (Visit 1);
20. use of any intravenous or intramuscular or oral or inhaled antipseudomonal antibiotic (except chronic macrolides azithromycin or erythromycin with a stable dose) within 30 days prior to Screening Visit (Visit 1);
21. 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 throughout their involvement in the trial;
22. Significant abnormality in clinical evaluations and/or laboratory tests (physical examination, vital signs, haematology, clinical chemistry, ECG) endangering the safe participat

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified