NBMI - Clinical Study on COPD (Emera003COPD)

March 4, 2021 updated by: EmeraMed

A Randomised, Placebo-controlled, Blinded, Cross-over, Pilot Study to Explore Safety and Efficacy of NBMI Treatment of Patients With Mild, Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD)

A pilot study to explore safety of the treatment with the antioxidant and metal chelator NBMI in COPD patients.

Investigational product: NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide), INN: Emeramide

Indication: Mild, moderate and severe COPD with bronchitis

A randomised, two arm, double-blind, placebo-controlled, cross-over, once daily for 14 days pilot study in subjects with COPD with bronchitis.

Study Overview

Status

Status

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

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.

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.
12

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 2

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

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects, age between 45 and 75 years, including
  2. Ex-smokers, who quit smoking > 6 months prior to screening visit, with a smoking history of at least 10 pack years
  3. Diagnosis of COPD according to GOLD stages I-III, i.e. Post-beta-2-agonist FEV1/FVC < 0.70 and Post-beta-2-agonist FEV1 >30 % of predicted value
  4. Active symptomatic COPD with a total COPD assessment test (CAT) score >10
  5. Bronchitis with cough and sputum production during many days of the last month, and at least three months during the last year
  6. Has signed informed consent for participation
  7. Willingness and ability to comply with study procedures, visit schedules, and other instructions regarding the study.

Exclusion Criteria:

  1. Patient with > 2 COPD exacerbation requiring treatment with systemic corticosteroids and/or antibiotics or hospitalization within the last year
  2. Patient with COPD exacerbation requiring treatment with systemic corticosteroids and/or antibiotics or hospitalization within the last 4 weeks
  3. New medication or change of dose for COPD treatment within 4 weeks prior to randomisation (chronic treatment with stable dose is allowed)
  4. Ongoing treatment with systemic steroids, antibiotics, oxygen treatment, N-acetylcysteine (NAC) or roflumilast within 4 weeks of randomisation
  5. Clinically significant heart failure, heart infarction, stroke or TIA within 12 months of study screening
  6. Ongoing treatment with warfarin at screening visit
  7. Ongoing treatment with medications that are metabolised or eliminated through the CYP P450 system, which could cause a drug interaction with the investigational product, as judged by the investigator, within 2 weeks of randomisation
  8. Ongoing treatment with metal containing medications, such as iron supplement, lithium medications or antacids, within 2 weeks of randomisation
  9. History of alcohol abuse or substance/drug abuse within 12 months prior to screening visit
  10. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subjects at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
  11. Any clinically significant abnormalities in clinical chemistry or haematology results at the time of screening, as judged by the investigator
  12. Total alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine > upper limit of normal (ULN) at screening
  13. History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the investigator, including history of hypersensitivity to drugs with a similar chemical structure or class to NBMI
  14. History of allergy/hypersensitivity to bisulphites (e.g. red/white wine)
  15. Women of child bearing potential who do not consent to using acceptable methods of contraception (i.e. one of the following: combined hormonal contraception and progestogen-

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

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.
Experimental: Treatment
14 days treatment with NBMI 300 mg/day
Drug: Emeramide
Lipophilic, membrane passing Metal chelator and anti oxidant
Other Names:
  • NBMI
  • Irminix
Placebo Comparator: Placebo
14 days treatment with Placebo
Drug: Placebo
14 days treatment with placebo

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
Safety and tolerability - Adverse events
Time Frame: 14 days
To evaluate the safety and tolerability of NBMI daily oral administration for 14 days in patients with mild, moderate and severe COPD. Adverse events in terms of frequency and severity compared to placebo treatment.
14 days

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
Cough - Changes from baseline in Leicester cough questionnaire compared to placebo treatment
Time Frame: 14 days
To investigate the efficacy of NBMI daily oral administration for 14 days on cough in patients with moderate and severe COPD. Changes from baseline in Leicester cough questionnaire compared to placebo treatment.
14 days
Individual symptoms CAT - Changes from baseline in COPD assessment (CAT) test compared to placebo treatment
Time Frame: 14 days
To investigate the efficacy of NBMI daily oral administration for 14 days on changes from baseline in COPD assessment (CAT) test compared to placebo treatment.
14 days
Individual symptoms mMRC - Changes from baseline in modified Medical Research Council (mMRC) dyspnoea scale compared to placebo treatment
Time Frame: 14 days
To investigate the efficacy of NBMI daily oral administration for 14 days on changes from baseline in in modified Medical Research Council (mMRC) dyspnoea scale compared to placebo treatment
14 days
Individual symptoms 6 min walking test - Changes from baseline in 6 Minute walk test measurements compared to placebo treatment
Time Frame: 14 days
To investigate the efficacy of NBMI daily oral administration for 14 days on changes from baseline in 6 Minute walk test measurements compared to placebo treatment
14 days
Individual symptoms MDP - Changes from baseline in Multidimensional Dyspnoea Profile (MDP) compared to placebo treatment
Time Frame: 14 days
To investigate the efficacy of NBMI daily oral administration for 14 days on changes from baseline in Multidimensional Dyspnoea Profile (MDP) compared to placebo treatment
14 days
Laboratory - Changes from baseline of standard haematology and clinical chemistry laboratory analyses (e.g. blood, kidney, liver, infections) compared to placebo treatment
Time Frame: 14 days
To investigate the efficacy of NBMI daily oral administration for 14 days on changes from baseline of standard haematology and clinical chemistry laboratory analyses (e.g. blood, kidney, liver, infections) compared to placebo treatment
14 days
Vital signs - Changes from baseline of vital signs (incl. oxygen saturation (spO2), blood pressure, pulse, body weight) compared to placebo treatment
Time Frame: 14 days
To investigate the efficacy of NBMI daily oral administration for 14 days on changes from baseline of vital signs (incl. oxygen saturation (spO2), blood pressure, pulse, body weight) compared to placebo treatment
14 days
Lung function FEV - Changes from baseline in pre-, post-bronchodilator and FVC compared to placebo treatment.
Time Frame: 14 days
To investigate the efficacy of NBMI daily oral administration for 14 days on lung function in patients with mild, moderate and severe COPD on changes from baseline in pre-, post-bronchodilator and FVC compared to placebo treatment.
14 days
Lung function St George - Changes from baseline in St George´s respiratory questionnaire compared to placebo treatment
Time Frame: 14 days
To investigate the efficacy of NBMI daily oral administration for 14 days on lung function in patients with mild, moderate and severe COPD on changes from baseline in St George´s respiratory questionnaire compared to placebo treatment
14 days

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.
EmeraMed

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 1, 2017

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.
May 30, 2018

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.
June 30, 2018

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).
April 5, 2017

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.
April 20, 2017

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.
April 21, 2017

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.
March 5, 2021

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.
March 4, 2021

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.
March 1, 2021

More Information

Terms related to this study

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.
  • Emera003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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