Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium.

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT03460704
• Date of registration: 14/02/2018
• Prospective Registration: No
• Primary sponsor: Zambon SpA
• Public title: Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium. PROMIS-II
• Scientific title: Efficacy and Safety of 12 Months of Therapy With Inhaled Colistimethate Sodium in Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With P. Aeruginosa
• Date of first enrolment: January 29, 2018
• Target sample size: 287
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03460704
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Canada, France, Germany, Greece, Israel, Italy, New Zealand, Poland, Portugal, United States

Contacts

• Name: Paola Castellani, MD
• Affiliation: Zambon S.p.A.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. are able and willing to give informed consent, following a detailed explanation of
partecipation 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 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 the Screening Visit (Visit 1) or planned
inpatient major surgery during the study period;

6. receiving treatment for allergic bronchopulmonary aspergillosis (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. 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 evidence of bronchial
hyper-reactivity following inhaled colistimethate sodium;

14. treatment with long term (= 30 days) prednisone at a dose of greater than 15 mg a day
(or equivalent dose of any other corticosteroid) started within six months of the
Screening Visit (Visit 1);

15. new maintenance treatment with any oral macrolides ( (e.g.
azithromycin/erythromycin/clarithromycin) within 30 days of the Screening Visit (Visit
1) or started between Visit 1 and Visit 2;

16. 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;

17. 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;

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non Cystic Fibrosis Bronchiectasis

Intervention(s)

Drug: CMS

Other: Placebo

Primary Outcome(s)

Mean Annual Non-cystic Fibrosis Bronchiectasis (NCFB) Pulmonary Exacerbation Rate [Time Frame: 12 months]

Secondary ID(s)

Z7224L02

2016-004558-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/12/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03460704