Back to resultsNBMI - Clinical Study on COPD (Emera003COPD)
Primary Purpose
COPD, COPD Bronchitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Emeramide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COPD
Eligibility Criteria
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:
- 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-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Placebo
Arm Description
14 days treatment with NBMI 300 mg/day
14 days treatment with Placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
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
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
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
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
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03123692
Brief Title
NBMI - Clinical Study on COPD
Acronym
Emera003COPD
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EmeraMed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, COPD Bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
A randomised, two arm, double-blind, placebo-controlled, cross-over, once daily for 14 days and 28 days follow up
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
14 days treatment with NBMI 300 mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
14 days treatment with Placebo
Intervention Type
Drug
Intervention Name(s)
Emeramide
Other Intervention Name(s)
NBMI, Irminix
Intervention Description
Lipophilic, membrane passing Metal chelator and anti oxidant
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
14 days treatment with placebo
Primary Outcome Measure Information:
Title
Safety and tolerability - Adverse events
Description
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 Outcome Measure Information:
Title
Cough - Changes from baseline in Leicester cough questionnaire compared to placebo treatment
Description
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
Title
Individual symptoms CAT - Changes from baseline in COPD assessment (CAT) test compared to placebo treatment
Description
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
Title
Individual symptoms mMRC - Changes from baseline in modified Medical Research Council (mMRC) dyspnoea scale compared to placebo treatment
Description
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
Title
Individual symptoms 6 min walking test - Changes from baseline in 6 Minute walk test measurements compared to placebo treatment
Description
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
Title
Individual symptoms MDP - Changes from baseline in Multidimensional Dyspnoea Profile (MDP) compared to placebo treatment
Description
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
Title
Laboratory - Changes from baseline of standard haematology and clinical chemistry laboratory analyses (e.g. blood, kidney, liver, infections) compared to placebo treatment
Description
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
Title
Vital signs - Changes from baseline of vital signs (incl. oxygen saturation (spO2), blood pressure, pulse, body weight) compared to placebo treatment
Description
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
Title
Lung function FEV - Changes from baseline in pre-, post-bronchodilator and FVC compared to placebo treatment.
Description
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
Title
Lung function St George - Changes from baseline in St George´s respiratory questionnaire compared to placebo treatment
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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-
12. IPD Sharing Statement
Learn more about this trial
NBMI - Clinical Study on COPD
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