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

  • STATUS
    Recruiting
  • days left to enroll
    35
  • participants needed
    420
  • sponsor
    Zambon SpA
Updated on 15 October 2021

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.

Details
Condition Non Cystic Fibrosis Bronchiectasis
Treatment Saline solution, Colistimethate Sodium
Clinical Study IdentifierNCT03460704
SponsorZambon SpA
Last Modified on15 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

able and willing to give informed consent
aged 18 years or older of either gender
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
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 (V1) and had no pulmonary exacerbation with or without treatment during the period between Visit 1 and Visit 2
have a documented history of P. aeruginosa infection
are clinically stable and have not required a change in pulmonary treatment for at least 30 days before the Screening Visit
have pre-bronchodilator FEV1 25% of predicted
had a positive sputum culture for P. aeruginosa from an adequate sample taken at the Screening Visit or during the screening period

Exclusion Criteria

known bronchiectasis as a consequence of cystic fibrosis (CF)
known history of hypogammaglobulinaemia requiring treatment with immunoglobulin, unless fully replaced and considered immuno-competent by the Investigator
myasthenia gravis or porphyria
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
had major surgery in the 3 months prior to the Screening Visit (Visit 1) or planned inpatient major surgery during the study period
receiving treatment for ABPA
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
respiratory failure that would compromise patient safety or confound the evaluation of safety or efficacy of the study in the opinion of the Investigator
current active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin without metastases
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)
known history of human immunodeficiency virus (HIV)
current treatment for non-tuberculous mycobacterial (NTM) lung disease or tuberculosis
known or suspected to be allergic or unable to tolerate colistimethate sodium (intravenous or inhaled) or other polymixins, including evidence of bronchial hyper-reactivity following inhaled colistimethate sodium
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)
new maintenance treatment with any oral macrolides within 30 days of the Screening Visit (Visit 1) or started between Visit 1 and Visit 2
use of any intravenous or intramuscular or oral or inhaled anti-pseudomonal antibiotic (except chronic macrolides with a stable dose) within 30 days prior to the Screening Visit (Visit 1) and between Visit 1 and Visit 2
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
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
participated in another investigational, interventional trial within 30 days prior to the Screening Visit (Visit 1)
in the opinion of the Investigator not suitable for inclusion for whatever reason
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