CompletedNCT03123692Emera003COPDUpdated Mar 5, 2021

NBMI - Clinical Study on COPD

A Phase 2 interventional study of Emeramide and Placebo in COPD and COPD Bronchitis, sponsored by EmeraMed. Completed. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-03-05.

Sponsored by EmeraMed · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 45 Years to 75 Years
Sex: All

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.

Conditions studied

COPD
COPD Bronchitis

Browse trials for

Bronchitis 269

Who can participate

Ages eligible: 45 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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-

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Participant)
Enrollment: 12 participants (actual)

Study arms

Experimental
Treatment
14 days treatment with NBMI 300 mg/day
Drug: Emeramide
Placebo comparator
Placebo
14 days treatment with Placebo
Drug: Placebo

Interventions

DrugEmeramide
Lipophilic, membrane passing Metal chelator and anti oxidant
Also known as: NBMI, Irminix
DrugPlacebo
14 days treatment with placebo

What researchers measure

Primary outcomes

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.
Time frame: 14 days

Secondary outcomes

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

Study locations

No study locations are listed for this record.

Registry details

Key details

Study ID: NCT03123692
Lead sponsor: EmeraMed
Responsible party: Sponsor
First posted: Apr 21, 2017
Start date: Jan 1, 2017
Primary completion: May 30, 2018
Completion: Jun 30, 2018
Last update: Mar 5, 2021

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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