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Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium (PROMIS II)

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ClinicalTrials.gov Identifier: NCT03460704
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Zambon SpA

Brief Summary:
The primary objectives of the trial is to investigate the effect of the use of inhaled colistimethate sodium, administered twice daily via the I-neb for 12 months, compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFB) chronically infected with P. aeruginosa on the frequency of pulmonary exacerbations.

Condition or disease Intervention/treatment Phase
Non Cystic Fibrosis Bronchiectasis Drug: Colistimethate sodium Drug: Saline Solution Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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)
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Drug: Colistimethate Sodium
1 M units equivalent to 80 mg colistimethate sodium diluted in 1 mL saline solution 0.45% Other Name: Promixin
Drug: Colistimethate sodium
Inhaled colistimethate sodium twice daily
Other Name: Promixin

Placebo Comparator: Drug: Saline Solution
1 ml saline solution 0.45%
Drug: Saline Solution
Inhaled placebo twice daily




Primary Outcome Measures :
  1. Annualized Pulmonary Exacerbation rate [ Time Frame: 12 months ]
    Annual mean NCFB pulmonary exacerbation rate.


Secondary Outcome Measures :
  1. Time to first pulmonary exacerbation [ Time Frame: 12 months ]
    Time (in days) from the first dose of IMP until the first pulmonary exacerbation;

  2. Annualised number of pulmonary exacerbation-free days [ Time Frame: 12 months ]
    Number of exacerbation-free days

  3. Number of severe NCFB pulmonary exacerbations, [ Time Frame: 12 months ]
    severe NCFB pulmonary exacerbations are defined as those requiring intravenous antibiotics and/or hospitalisation;

  4. Time to first severe pulmonary exacerbation [ Time Frame: 12 months ]
    Time (in days) from first dose of IMP until the first severe pulmonary exacerbation

  5. Quality of life (SGRQ) [ Time Frame: 12 Months ]
    Quality of life (QoL) as measured by the total score of the Saint George's Respiratory Questionnaire (SGRQ)

  6. Quality of Life (Qol-B) [ Time Frame: 12 months ]
    Quality of Life - Bronchiectasis (QOL B) as measured by the total score of the ) and Quality of Life - Bronchiectasis (QOL B) questionnaire

  7. Days of work absence [ Time Frame: 12 months ]
    Number of days of work absence due to NCFB pulmonary exacerbations

  8. P. aeruginosa density [ Time Frame: 12 months ]
    mean change in log10 colony forming units (CFU)/g sputum from baseline (Visit 2) to Day 28 of treatment (Visit 3) as well as to Visits 5 (6 months) to 11 (24 months) inclusive.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. able and willing to give informed consent
  2. 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 pulmonary exacerbation requiring intravenous antibiotics in the 12 months preceding the Screening Visit (V1) and had no 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
  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

Exclusion Criteria:

  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 ABPA;
  7. massive haemoptysis (greater than or equal to 300 mL or requiring blood transfusion) in the preceding 4 weeks before Screening Visit (Visit 1) or between Visit 1 and Visit 2;
  8. predominant lung condition being chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease or smoking-related lung disease, without significant bronchiectasis in the opinion of the Investigator;
  9. respiratory failure requiring long term 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, cyclosporin, tacrolimus, sirolimus, mycophenolate, anti-cytokine medications, rituximab, 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 infection or tuberculosis;
  14. known to be intolerant to inhaled beta-2 agonists (bronchodilators);
  15. known or suspected to be allergic or unable to tolerate colistimethate sodium or other polymixins (intravenous or inhaled) including evidence of bronchial hyperreactivity;
  16. treatment with long term (≥ 30 days) prednisone at a dose of greater than 15 mg a day (or equivalent dose of any other corticosteroid) (e.g. azithromycin/erythromycin/clarithromycin) started within six months of the Screening Visit (Visit 1);
  17. new maintenance treatment with any oral macrolides 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 macrolides [azithromycin or erythromycin] 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 two years 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 safe participation of the patient in the study at the Screening Visit (Visit 1) and during the study;
  21. participated in another investigational, interventional trial within 30 days prior to the Screening Visit (Visit 1);
  22. in the opinion of the Investigator not suitable for inclusion for whatever reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460704


Contacts
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Contact: Michela Meroni, MSc + 39 02 66524208 clinicaltrials@zambongroup.com
Contact: Luca Raiteri, MD + 39 02 66524624 clinicaltrials@zambongroup.com

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Sponsors and Collaborators
Zambon SpA
Investigators
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Study Director: Luca Raiteri, MD Zambon SpA

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Responsible Party: Zambon SpA
ClinicalTrials.gov Identifier: NCT03460704     History of Changes
Other Study ID Numbers: Z7224L02
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Bronchiectasis
Fibrosis
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
Colistin
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents