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Long Term Efficacy and Safety of Inhaled Colistimethate Sodium in Bronchiectasis Subjects With Chronic Pseudomonas Aeruginosa Infection. (PROMIS-I)

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ClinicalTrials.gov Identifier: NCT03093974
Recruitment Status : Completed
First Posted : March 28, 2017
Last Update Posted : August 10, 2021
Information provided by (Responsible Party):
Zambon SpA

Brief Summary:
The primary objective 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)
Actual Enrollment : 377 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 : June 6, 2017
Actual Primary Completion Date : April 9, 2021
Actual Study Completion Date : April 9, 2021

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

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

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 ]
    change from baseline in total score 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 ]
    the 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 7 (12 months), inclusive

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  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 gender;
  3. diagnosed with NCFB by computerised tomography (CT) or high resolution CT (HRCT) as recorded in the subject's notes and this is their predominant condition being treated;
  4. had at least 2 NCFB pulmonary exacerbations requiring oral or inhaled 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 ≥25% of predicted;
  8. had a positive sputum culture for P. aeruginosa from an adequate sample taken at the Screening Visit (Visit 1) or during the screening period.

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 or porphyria;
  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 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 Screening Visit (Visit 1) or between Visit 1 and Visit 2;
  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 (such as azathioprine, 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);
  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, including previous evidence of bronchial hyperreactivity following inhaled colistimethate sodium;
  14. treatment with long term (≥ 30 days) prednisone at a dose greater than 15 mg a day (or equivalent dose of any other corticosteroid) within six months of the Screening Visit (Visit 1)
  15. new maintenance treatment with any oral macrolides (e.g. azithromycin/erythromycin/clarithromycin) started within 30 days of the Screening Visit (Visit 1) and between Visit 1 and Visit 2;
  16. use of any intravenous or intramuscular or oral or inhaled antipseudomonal antibiotic (except chronic oral macrolide treatment with a stable dose) within 30 days prior to Screening Visit (Visit 1) and between Visit 1 and Visit 2;
  17. 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;
  18. 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;
  19. participated in another investigational, interventional trial within 30 days prior to the Screening Visit (Visit 1);
  20. 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): NCT03093974

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Sponsors and Collaborators
Zambon SpA
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Study Director: Dearbhla Hull, MD Zambon SpA
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Responsible Party: Zambon SpA
ClinicalTrials.gov Identifier: NCT03093974    
Other Study ID Numbers: Z7224L01
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases