NBMI - Clinical Study on COPD

Last updated: March 4, 2021
Sponsor: EmeraMed
Overall Status: Completed

Phase

2

Condition

Bronchitis

Treatment

N/A

Clinical Study ID

NCT03123692
Emera003
  • Ages 45-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 smokinghistory 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 atleast 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 otherinstructions regarding the study.

Exclusion

Exclusion Criteria:

  1. Patient with > 2 COPD exacerbation requiring treatment with systemic corticosteroidsand/or antibiotics or hospitalization within the last year
  2. Patient with COPD exacerbation requiring treatment with systemic corticosteroidsand/or antibiotics or hospitalization within the last 4 weeks
  3. New medication or change of dose for COPD treatment within 4 weeks prior torandomisation (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 monthsof study screening
  6. Ongoing treatment with warfarin at screening visit
  7. Ongoing treatment with medications that are metabolised or eliminated through the CYPP450 system, which could cause a drug interaction with the investigational product, asjudged by the investigator, within 2 weeks of randomisation
  8. Ongoing treatment with metal containing medications, such as iron supplement, lithiummedications or antacids, within 2 weeks of randomisation
  9. History of alcohol abuse or substance/drug abuse within 12 months prior to screeningvisit
  10. History of any clinically significant disease or disorder which, in the opinion of theinvestigator, may either put the subjects at risk because of participation in thestudy, or influence the results or the subject's ability to participate in the study
  11. Any clinically significant abnormalities in clinical chemistry or haematology resultsat 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, asjudged by the investigator, including history of hypersensitivity to drugs with asimilar 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 ofcontraception (i.e. one of the following: combined hormonal contraception andprogestogen-

Study Design

Total Participants: 12
Study Start date:
January 01, 2017
Estimated Completion Date:
June 30, 2018