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NBMI - Clinical Study on COPD (Emera003COPD)

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ClinicalTrials.gov Identifier: NCT03123692
Recruitment Status : Not yet recruiting
First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
EmeraMed

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.


Condition or disease Intervention/treatment Phase
COPD COPD Bronchitis Drug: Emeramide Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A randomised, two arm, double-blind, placebo-controlled, cross-over, once daily for 14 days and 28 days follow up
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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)
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : November 30, 2017
Estimated Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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-

Responsible Party: EmeraMed
ClinicalTrials.gov Identifier: NCT03123692     History of Changes
Other Study ID Numbers: Emera003
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Bronchitis
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Bronchial Diseases
Respiratory Tract Infections