NBMI - Clinical Study on COPD

NCT03123692 | Completed Phase 2

• 1 other identifier: Emera003
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

COPD; COPD Bronchitis

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability - Adverse events

  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 Outcomes (9)

• Cough - 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

  14 days

• Individual symptoms mMRC - Changes from baseline 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

  14 days

• Individual symptoms MDP - Changes from baseline in Multidimensional Dyspnoea Profile (MDP) compared to placebo treatment

  14 days

Study Arms (2)

Treatment

EXPERIMENTAL

14 days treatment with NBMI 300 mg/day

Drug: Emeramide

Placebo

PLACEBO COMPARATOR

14 days treatment with Placebo

Drug: Placebo

Interventions

Emeramide DRUG

Lipophilic, membrane passing Metal chelator and anti oxidant

Also known as: NBMI, Irminix

Treatment

Placebo DRUG

14 days treatment with placebo

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, age between 45 and 75 years, including
• Ex-smokers, who quit smoking \> 6 months prior to screening visit, with a smoking history of at least 10 pack years
• 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
• Active symptomatic COPD with a total COPD assessment test (CAT) score \>10
• Bronchitis with cough and sputum production during many days of the last month, and at least three months during the last year
• Has signed informed consent for participation
• Willingness and ability to comply with study procedures, visit schedules, and other instructions regarding the study.

You may not qualify if:

• Patient with \> 2 COPD exacerbation requiring treatment with systemic corticosteroids and/or antibiotics or hospitalization within the last year
• Patient with COPD exacerbation requiring treatment with systemic corticosteroids and/or antibiotics or hospitalization within the last 4 weeks
• New medication or change of dose for COPD treatment within 4 weeks prior to randomisation (chronic treatment with stable dose is allowed)
• Ongoing treatment with systemic steroids, antibiotics, oxygen treatment, N-acetylcysteine (NAC) or roflumilast within 4 weeks of randomisation
• Clinically significant heart failure, heart infarction, stroke or TIA within 12 months of study screening
• Ongoing treatment with warfarin at screening visit
• 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
• Ongoing treatment with metal containing medications, such as iron supplement, lithium medications or antacids, within 2 weeks of randomisation
• History of alcohol abuse or substance/drug abuse within 12 months prior to screening visit
• 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
• Any clinically significant abnormalities in clinical chemistry or haematology results at the time of screening, as judged by the investigator
• Total alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine \> upper limit of normal (ULN) at screening
• 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
• History of allergy/hypersensitivity to bisulphites (e.g. red/white wine)
• 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-

Sponsors & Collaborators

• EmeraMed: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

N,N'-Bis(2-mercaptoethyl)isophthalamide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomised, two arm, double-blind, placebo-controlled, cross-over, once daily for 14 days and 28 days follow up

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 21, 2017
• Study Start: January 1, 2017
• Primary Completion: May 30, 2018
• Study Completion: June 30, 2018
• Last Updated: March 5, 2021

Record last verified: 2021-03