J44.9
Conditions
Interventions
Group 1: Inhalation: Verum (10 mg hgd40 in 2ml solution, = SB010), BID for 27 days, OD at day 28
Group 2: Inhalation: Placebo (2ml solution), BID for 27 days, OD at day 28
Sponsors
Philipps-Universität Marburg
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult male and female Caucasian patients aged = 40. 2. Clinical diagnosis of moderate to severe, stable COPD, defined as a postbronchodilator Forced Expiratory Volume in One Second (FEV1) greater than 30 % of the predicted normal value and less than 80 % of the predicted normal value, and post-bronchodilator FEV1/FVC less than 0.7. 3. Patients on stable COPD medication at least 4 weeks prior to screening 4. Sputum eosinophils = 2.5% at screening. 5. Current or ex-smoker with a smoking history of = 10 packyears 6. Ability to inhale in an appropriate manner (patients will be trained to inhale from the AKITA2 APIXNEB® device with a placebo medication at the screening visit) 7. Only men who do not want to father children for six months after the last dose of SB010 8. Only women who don’t plan pregnancy for six months after the last dose of SB010 9. WOCBP must use a double barrier method of contraception during the study and for 6 months following the last dose of study medication. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months). 10. Male subjects whose sexual partners are WOCBP must use a double barrier method of contraception, one of which includes a condom, during the study and for 6 months after the end of treatment. 11. Patient is able to understand and give written informed consent 12. Provision of a written informed consent on participation in the trial prior to trial start and any trial-related procedures
Exclusion criteria
Exclusion criteria: 1. Presence of clinically significant diseases other than COPD and known COPD comorbidities (cardiovascular, renal, hepatic, gastrointestinal, haematological, neurological, genitourinary, autoimmune, endocrine, metabolic, etc.), which, in the opinion of the investigator, may put the patient at risk because of participation in the trial 2. Diseases which may influence the results of the study or the patient’s ability to take part in it 3. Presence of relevant pulmonary diseases or history of thoracic surgery, such as: - known active tuberculosis, - history of interstitial lung or pulmonary thromboembolic disease, - pulmonary resection during the past 12 months, - history of asthma - history of bronchiectasis secondary to respiratory diseases (e.g. cystic fibrosis, Kartagener’s syndrome, etc.), - history of allergic bronchopulmonary aspergillosis or respiratory infection within the 4 preceding weeks of the first morning IMP administration 4. Clinically relevant acute infections in the last 4 weeks prior to randomization 5. Clinically relevant chronic infections 6. known clinically relevant allergies or idiosyncrasy to oligonucleotide based drugs 7. History of allergic reactions to any active or inactive ingredients of the nebulizer solution 8. Proneness to orthostatic dysregulation, faintings, or blackouts 9. History of malignancy within the past 5 years, except excised basaliomas 10. Clinically relevant abnormalities (except of known COPD / comorbidity related abnormalities) in clinical chemical, haematological or in any other laboratory variables as judged by the investigator 11. Positive results in any of the virology tests of acute or chronic infectious human immunodeficiency virus (HIV) and hepatitis B/C virus infections 12. Positive drug screen 13. Abuse of alcohol or drugs 14. Treatment with any known enzyme inducing or inhibiting agents (St. John's Wort (Johanniskraut), barbiturates, phenothiazines, cimetidine, ketoconazole etc.) within 30 days before first administration of trial medication or during treatment period of the trial 15. Treatment with any biologicals within three months before first administration of trial medication or during treatment period of the trial (only allowed by judgement of principal investigator) 16. Surgery of the gastrointestinal tract which may interfere with drug absorption of swallowed fraction (Note: this is not applicable for minor abdominal surgery such as appendectomy or herniotomy), 17. Planned lung transplantation 18. Blood donation within the last 30 days before screening 19. Planned donation of germ cells, blood, organs or bone marrow during the course of the trial or within 6 months thereafter 20. Participation in another clinical trial with an investigational drug or device within the last month or within 10 times the half-life of the respective drug. For biologics the minimum period is 10 times the half-life of the respective drug before inclusion in this trial 21. Lack of ability or willingness to give informed consent or inability to cooperate adequately 22. Anticipated non-availability for trial visits/procedures 23. Vulnerable subjects (e.g., persons kept in detention) 24. Employee at the investigational site, relative or spouse of the investigator. 25. Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of feasibility of conducting a larger phase II trial as determined by: - number of eligible patients / screening failures in light of specific inclusion / exclusion criteria; - duration of recruiting period; - number of randomized patients not evaluable due to, e.g. non-evaluable sputum; - suitability of inhalation device, patient compliance, and device handling - compliance to schedule for screening procedures (Day -28 to -7) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy and pharmacodynamics - treatment effect after 28 days in reducing percentage of eosinophils in sputum; - treatment effect after 28 days in reducing FeNO; - treatment effect after 28 days in improving lung function (FEV1, FVC) - treatment effect after 28 days in improving symptom scores; - impact on exploratory biomarker analysis Pharmacokinetics Safety and tolerability | — |
Countries
Germany
Contacts
Public ContactTimm Greulich
Universitätsklinikum Gießen u. Marburg GmbH, Standort MarburgKlinik für Pneumologie
Outcome results
None listed