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

December 11, 2023 updated by: Zambon SpA

Efficacy and Safety of 12 Months of Therapy With Inhaled Colistimethate Sodium in Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With P. Aeruginosa

The primary objective of the trial was to investigate the effect of the use of inhaled colistimethate sodium (CMS), administered twice a day (b.i.d.) via a specific nebulizer for 12 months, compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFB) chronically infected with P. aeruginosa on the annualised frequency of pulmonary exacerbations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This was a randomised, multi-centre, double-blind, placebo-controlled, parallel-group interventional trial in subjects with NCFB chronic P. aeruginosa infection. Subjects were randomised to CMS or placebo in a 1:1 ratio. The study consisted of 7 clinic visits with a follow-up phone call 12.5 month after randomisation or 2 weeks after discontinuation of treatment. Additional clinic visits, where feasible, and weekly phone calls were conducted during or after pulmonary exacerbations (or any episodes of pneumonia) until resolution.

Every effort was made to have all planned and unscheduled visits at the study site. Mandatory on-site visits were Screening Visit (Visit 1) and Randomisation (Visit 2). However, if one of the visits after Visit 2 could not be performed at site due to COVID-19, remote visits (e.g., by telephone) were permitted. If the final visit (Visit 7) had to be conducted remotely, the subjects were asked to return to the clinic for on-site assessments at the earliest opportunity.

After consulting with the US Food and Drug Administration, the study was brought to an early close primarily due to the difficulty of recruiting subjects in the context of the COVID pandemic, but also due to the potential for loss of scientific equipoise and the ethical implications of continuing to expose subjects to placebo given the positive results from PROMIS I. Recruitment to PROMIS II was stopped as of 27 October 2021, with the study terminated as of 15 March 2022. The study was not stopped prematurely due to any safety or futility concerns and the accrued data were fully analysed and are presented.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
287

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1704
        • Zambon Investigative Site
      • Buenos Aires, Argentina, 1842
        • Zambon Investigative Site
      • Buenos Aires, Argentina, 1888
        • Zambon Investigative Site
      • Buenos Aires, Argentina, B1602DQD
        • Zambon Investigative Site
      • Buenos Aires, Argentina, B1900BNJ
        • Zambon Investigative Site
      • Buenos Aires, Argentina, C1425AZB
        • Zambon Investigative Site
      • Ciudad Autónoma de Buenos Aires, Argentina, 1425
        • Zambon Investigative Site
      • Ciudad Autónoma de Buenos Aires, Argentina, 1426
        • Zambon Investigative Site
      • Quilmes, Argentina, B1878FNR
        • Zambon Investigative Site
      • Santa Fe, Argentina, S3000ASF
        • Zambon Investigative Site
      • Tucumán, Argentina, 4000
        • Zambon Investigative Site
  • Australia
      • Adelaide, Australia, 5000
        • Zambon Investigative Site
      • Concord, Australia, 2139
        • Zambon Investigative Site
      • Greenslopes, Australia, 4120
        • Zambon Investigative Site
      • Kent Town, Australia, 5067
        • Zambon Investigative Site
      • South Brisbane, Australia, 4101
        • Zambon Investigative Site
      • Spearwood, Australia, 6163
        • Zambon Investigative Site
  • Canada
      • Burlington, Canada, L7N 3V2
        • Zambon Investigative Site
      • Kelowna, Canada, VIY 3H2
        • Zambon Investigative Site
      • London, Canada, N6A 5W9
        • Zambon Investigative Site
      • Montréal, Canada, H2X03E4
        • Zambon Investigative Site
      • Ottawa, Canada, K1H8L6
        • Zambon Investigative Site
      • Quebec City, Canada, G1V 4G5
        • Zambon Investigative Site
      • Winnipeg, Canada, R2H 2A6
        • Zambon Investigative Site
  • France
      • Amiens, France, 80054
        • Zambon Investigative Site
      • Brest, France, 29200
        • Zambon Investigative Site
      • Créteil, France, 94010
        • Zambon Investigative Site
      • La Tronche, France, 38700
        • Zambon Investigative Site
      • Lyon, France, 69004
        • Zambon Investigative Site
      • Montpellier, France, 34295
        • Zambon Investigative Site
      • Nice, France, 51069
        • Zambon Investigative Site
      • Pessac, France, 33604
        • Zambon Investigative Site
      • Reims, France, 51092
        • Zambon Investigative Site
      • Toulouse, France, 31059
        • Zambon Investigative Site
  • Germany
      • Frankfurt, Germany, 60596
        • Zambon Investigative Site
      • Hanover, Germany, 30625
        • Zambon Investigative Site
  • Greece
      • Athens, Greece, 11527
        • Zambon Investigative Site
  • Israel
      • Haifa, Israel, 34362
        • Zambon Investigative Site
      • Jerusalem, Israel, 9703102
        • Zambon Investigative Site
      • Kfar Saba, Israel, 4428164
        • Zambon Investigative Site
  • Italy
      • Milano, Italy, 20122
        • Zambon Investigative Site
      • Monza, Italy, 20900
        • Zambon Investigative Site
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Zambon Investigative Site
      • Havelock North, New Zealand, 4130
        • Zambon Investigative Site
      • Mount Cook, New Zealand, 6021
        • Zambon Investigative Site
      • Tauranga, New Zealand, 3110
        • Zambon Investigative Site
  • Poland
      • Białystok, Poland, 15-044
        • Zambon Investigative Site
      • Bielsko-Biala, Poland, 43-300
        • Zambon Investigative Site
      • Cracovia, Poland, 31-066
        • Zambon Investigative Site
      • Grudziądz, Poland, 86300
        • Zambon Investigative Site
      • Legnica, Poland, 59220
        • Zambon Investigative Site
      • Lublin, Poland, 20-089
        • Zambon Investigative Site
      • Ostrowiec Świętokrzyski, Poland, 27-400
        • Zambon Investigative Site
      • Piaseczno, Poland, 05-500
        • Zambon Investigative Site
      • Proszowice, Poland, 32-100
        • Zambon Investigative Site
      • Rzeszów, Poland, 35-205
        • Zambon Investigative Site
      • Sosnowiec, Poland, 41-200
        • Zambon Investigative Site
      • Warszawa, Poland, 01-456
        • Zambon Investigative Site
      • Wrocław, Poland, 51-162
        • Zambon Investigative Site
      • Łódź, Poland, 94-048
        • Zambon Investigative Site
  • Portugal
      • Guimarães, Portugal, 4835-044
        • Zambon Investigative Site
      • Lisboa, Portugal, 1649035
        • Zambon Investigative Site
  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Zambon Investigative Site
      • Palm Springs, California, United States, 92262
        • Zambon Investigative Site
      • Reseda, California, United States, 91324
        • Zambon Investigative Site
      • San Diego, California, United States, 92120-5241
        • Zambon Investgative Site
      • San Diego, California, United States, 92103
        • Zambon Investigative Site
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Zambon Investigative Site
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Zambon Investigative Site
      • Kissimmee, Florida, United States, 34741
        • Zambon Investigative Site
      • Orlando, Florida, United States, 32803
        • Zambon Investigative Site
      • Saint Petersburg, Florida, United States, 33704
        • Zambon Investigative Site
      • Saint Petersburg, Florida, United States, 33707
        • Zambon Investigative Site
      • Weston, Florida, United States, 33331
        • Zambon Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Zambon Investigative Site
    • Indiana
      • Michigan City, Indiana, United States, 46360
        • Zambon Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Zambon Investigative Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Zambon Investigative Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017-3625
        • Zambon Investigative Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-1000
        • Zambon Investigative Site
    • New York
      • New York, New York, United States, 10016
        • Zambon Investigative Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Zambon Investigative Site
      • Durham, North Carolina, United States, 27705
        • Zambon Investigative Site
      • Winston-Salem, North Carolina, United States, 27265
        • Zambon Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Zambon Investigative Site
    • Texas
      • Tyler, Texas, United States, 75708
        • Zambon Investigative Site
    • Virginia
      • Abingdon, Virginia, United States, 24210
        • ZambonInvestigative Site
      • Richmond, Virginia, United States, 23219
        • Zambon Investigative Site
    • Washington
      • Northwest, Washington, United States, 20007
        • Zambon Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Saline solution inhaled twice daily, provided and administered at the same way of the IMP.
Other: Placebo
1 mL saline solution 0.45%. The placebo was made up of identical empty glass vials to which the same saline solution diluent was added in exactly the same way as the reconstitution of the active treatment by injecting the diluent through the rubber stopper. The glass vials were shrink wrapped with opaque white plastic to mantain the blind.
Other Names:
  • Saline Solution
Experimental: CMS (Colistimethate Sodium)
Inhaled colistimethate sodium twice daily. The active pharmaceutical ingredient consisting of pure CMS one million international units (MIU) / 80 mg of CMS / 33 mg colistin base activity (CBA) was provided as a powder for nebuliser solution in 10R Internation Organization for Standardization (ISO) glass vials.
Drug: CMS

1 MIU equivalent to 80 mg colistimethate sodium diluted in 1 mL saline solution 0.45%. Investigational Medicinal Product (IMP) glass vials were shrink wrapped in opaque white plastic and provided in boxes of 30 vials (two weeks of b.i.d. dosing).

The 1 MIU/ml CMS/0.45% saline solution was transferred from the glass vial into a specific nebuliser system fitted with a 0.3 mL medication chamber, for administration by inhalation. This delivered a nominal dose of 0.3 MIU/24 mg CMS (11 mg CBA) from the device.

The first dose of the IMP was administered at the site under the supervision of the site staff and subjects were instructed how to prepare and self-administer the IMP at home via a specific nebuliser system, b.i.d. (morning and evening) over aperiod of 12 month.

At least 10 minutes (min) before each administration, an inhaled short-acting bronchodilator (e.g. salbutamol/albuterol), supplied by the Sponsor, could be taken to improve tolerability.

Other Names:
  • Promixin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Annual Non-cystic Fibrosis Bronchiectasis (NCFB) Pulmonary Exacerbation Rate
Time Frame: 12 months

The primary efficacy assessment for an individual subject was the frequency of pulmonary exacerbations (exacerbation rate). A pulmonary exacerbation was defined as the presence concurrently of at least three of the following eight symptoms/signs for at least 24 hours:

  • increased cough;
  • increased sputum volume and/or consistency;
  • increased sputum purulence;
  • new or increased haemoptysis;
  • increased wheezing;
  • increased dyspnoea;
  • increased fatigue/malaise and
  • episodes of fever (temperature ≥38°C). AND It was clinically determined that the subject required and was prescribed systemic antibiotic therapy. AND The episode of exacerbation lasted for at least 24 hours. The overall episode of exacerbation needs to last at least 24 hours, but individual symptoms/signs can last less than 24 hours (e.g, a temperature)
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to first pulmonary exacerbation
Time Frame: 12 months
Time (in days) from the first dose of IMP until the first pulmonary exacerbation;
12 months
Annualised number of pulmonary exacerbation-free days
Time Frame: 12 months
Number of exacerbation-free days
12 months
Number of severe NCFB pulmonary exacerbations,
Time Frame: 12 months
severe NCFB pulmonary exacerbations are defined as those requiring intravenous antibiotics and/or hospitalisation;
12 months
Time to first severe pulmonary exacerbation
Time Frame: 12 months
Time (in days) from first dose of IMP until the first severe pulmonary exacerbation
12 months
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)
12 Months
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
12 months
Days of work absence
Time Frame: 12 months
Number of days of work absence due to NCFB pulmonary exacerbations
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zambon SpA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paola Castellani, MD, Zambon S.p.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Z7224L02
  • 2016-004558-13 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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