Trial record 2 of 2 for:    colistimethate | Bronchiectasis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03093974
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : October 9, 2018
Information provided by (Responsible Party):
Zambon SpA

Brief Summary:

The co-primary objectives of the trial are to investigate the effect of the use of inhaled colistimethate sodium, administered twice daily via the I-neb for 24 months, compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFB) chronically infected with P. aeruginosa on:

the frequency of pulmonary exacerbations; the number of exacerbation-free days.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 464 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 1, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

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

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

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

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

  4. 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)

  5. Quality of Life (QOL-B) [ Time Frame: 12 months ]
    change from baseline in total score Quality of Life - Bronchiectasis (QOL B) questionnaire

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

  7. 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;
  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. 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).

Exclusion Criteria:

  1. known bronchiectasis as a consequence of cystic fibrosis (CF);
  2. known history of hypogammaglobulinaemia requiring treatment with immunoglobulin;
  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 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. predominant lung condition being chronic obstructive pulmonary disease (COPD), asthma or interstitial lung disease in the opinion of the Investigator;
  9. receiving long term oxygen therapy or non-invasive ventilation for the management of respiratory failure;
  10. current active malignancy, except for basal cell carcinoma of the skin without metastases;
  11. taking immunosuppressive medications (such as azathioprine, methotrexate, ciclosporine, 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 mycobacterium (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 six months of the Screening Visit (Visit 1)
  17. new maintenance treatment with oral macrolides (e.g. azithromycin/erythromycin/clarithromycin) started within 30 days of the Screening Visit (Visit 1) and between Visit 1 and Visit 2;
  18. 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);
  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 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 identifier (NCT number): NCT03093974

Contact: Michela Meroni, MSc +39.02.6652.4208
Contact: Luca Raiteri, MD +39.02.6652.4624

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

Responsible Party: Zambon SpA Identifier: NCT03093974     History of Changes
Other Study ID Numbers: Z7224L01
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Pseudomonas Infections
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents