Patients with Chronic Obstructive Pulmonary Disease (COPD). MedDRA version: 19.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: Emeramide
Product Code: NBMI
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Emeramide
Current Sponsor code: N1, N3-bis(2-mercaptoethyl)isophthalamide
Concentration unit: mg mill
Sponsors
NBMI Science AB
Eligibility
Sex/Gender
All
Inclusion 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 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1. Patient with more than 2 COPD exacerbation requiring treatment with systemic corticosteriods 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. History of alcohol abuse or substance/drug abuse within 12 months prior to screening visit 8. 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 9. Any clinically significant abnormalities in clinical chemistry or haematology results at the time of screening, as judged by the investigator 10. 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 11. History of allergy/hypersensitivity to bisulphites (e.g. red/white wine) 12. Positive pregnancy test in women at screening visit 13. Serious bacterial or chronic viral infection such as human immunodeficiency virus (HIV) or hepatitis virus at screening visit 14. Participation in any other clinical study that included drug treatment within three months prior randomisation 15. Investigator considers subject unlikely to comply with study procedures, restrictions and requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives for this study is to evaluate the safety and tolerability of NBMI in patients with mild, moderate and severe COPD.;Secondary Objective: The secondary objectives of this study are: - To evaluate the efficacy of NBMI daily oral administration for 14 days on cough in patients with mild, moderate and severe COPD. - To evaluate the efficacy of NBMI daily oral administration for 14 days on COPD health status and individual symptoms in patients with mild, moderate and severe COPD. - To evaluate the efficacy of NBMI daily oral administration for 14 days on lung function in patients with mild, moderate and severe COPD. The exploratory objectives are: - To investigate the pharmacokinetics of NBMI in patients with mild, moderate and severe COPD. - To explore the effect of NBMI on a panel of inflammatory and oxidative stress biomarkers in patients with mild, moderate and severe COPD ;Primary end point(s): - Adverse events in terms of frequency and severity compared to placebo treatment;Timepoint(s) of evaluation of this end point: NBMI treatment period compared to placebo period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Changes from baseline in Leicester cough questionnaire compared to placebo treatment - Changes from baseline in pre- and post-bronchodilator FEV1 and FVC compared to placebo treatment - Changes from baseline in COPD assessment (CAT) test compared to placebo treatment - Changes from baseline in St George´s respiratory questionnaire compared to placebo treatment - Changes from baseline in modified Medical Research Council (mMRC) dyspnoea scale compared to placebo treatment - Changes from baseline in 6 Minute walk test measurements compared to placebo treatment - Changes from baseline in Multidimensional Dyspnoea Profile (MDP) compared to placebo treatment - Changes from baseline of standard haematology and clinical chemistry laboratory analyses (e.g. blood, kidney, liver, infections) compared to placebo treatment - Changes from baseline of vital signs (incl. oxygen saturation (spO2), blood pressure, pulse, body weight) compared to placebo treatment Exploratory endpoints: - Pharmacokinetic parameters derived from plasma concentrations of NBMI - Changes from baseline in oxidative stress-related biomarkers in plasma compared to placebo treatment - Changes from baseline in inflammatory biomarkers in plasma compared to placebo treatment - Changes from baseline in daily physical activity compared to placebo treatment;Timepoint(s) of evaluation of this end point: 14 days treatment compared to baseline | — |
Countries
Sweden
Contacts
Public ContactCEO
NBMI Science AB
Outcome results
None listed