Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Code: IMD-1041
Pharmaceutical Form: Capsule*
Current Sponsor code: IMD-1041
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the
Sponsors
Institute of Medicinal Molecular Design, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and non-pregnant, non-lactating females aged =40 and =80 years of age at the time of the screening visit. (Women of childbearing potential will be allowed to enter the trial only if they are using one medically approved i.e., mechanical or pharmacological) contraceptive measure. A female is considered to be of childbearing potential unless she has had an hysterectomy, is at least one year post-menopausal, or has undergone tubal ligation. All women of childbearing potential must have a negative pregnancy test at screening visit and week 12 (Visit 3) 2. Patients with a clinical diagnosis of COPD, grade 2 or 3 according to the GOLD guidelines 2007 and stable airway obstruction 3. Patients with a post-salbutamol FEV1 > 30% of the predicted value, =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History or current diagnosis of asthma, allergic rhinitis or atopy. N.B. Misdiagnosed asthma or childhood asthma is acceptable, however must be confirmed by the Investigator 2. Eosinophil count >600 cells/mm3 3. A respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to the screening visit 4. Patients who have been hospitalised for an acute COPD exacerbation in the 12 months or an exacerbation in the last 3 months which was treated with oral steroids prior to the screening visit 5. Use of long-term oxygen therapy (=15 hours/day) 6. Clinically significant respiratory conditions defined as: • Known active tuberculosis • History of interstitial lung or pulmonary thromboembolic disease • Pulmonary resection during the past 12 months • History of life-threatening COPD • History of bronchiectasis secondary to respiratory diseases other than COPD (e.g., cystic fibrosis, Kartagener’s syndrome, etc) • Patients who in the Investigator’s opinion may need pulmonary rehabilitation or a thoracotomy during the trial 7. Clinically significant cardiovascular conditions defined as: • Myocardial infarction during the last 6 months • Unstable arrhythmia which required changes in the pharmacological therapy or other intervention during the last 12 months, or newly diagnosed arrhythmia within the previous 3 months • Hospitalisation within the previous 12 months for heart failure functional classes III (marked limitation of activity and only comfortable at rest) and IV (need of complete rest, confinement to bed or chair, discomfort at any physical activity and presence of symptoms at rest) as per the New York Heart Association 8. Patients with any other serious or uncontrolled physical or mental dysfunction at the discretion of the Investigator, which could place the patient at higher risk derived from his/her participation in the study, could confound the results of the trial, or is likely to prevent the patient from complying with the requirements of the trial or completing the trial period 9. Patients who are not able to perform reproducible spirometry attempts at the screening visit or during the repeat at baseline 10. Clinically relevant abnormalities in the results of laboratory, ECG parameters (QTc > 470 milliseconds), or physical examination at the screening evaluation if the abnormality defines a disease state listed as an exclusion criterion, except for those related to COPD 11. Patients with a history of drug and/or alcohol abuse that may prevent compliance with trial activities 12. Treatment with any IMP within 3 month prior to screening visit 13. Changes to any concomitant therapy either for COPD or any other well-controlled illness within 1 month prior to screening visit 14. Treatment with a prohibited medication as detailed in Section 5.8 Any further issues regarding the eligibility of a particular patient for entry into the trial will be discussed between the Investigator and the Sponsor or its representatives and will be documented accordingly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the ability of IMD-1041 to reduce levels of selected systemic and induced sputum biomarkers in patients with COPD;Secondary Objective: • To evaluate change in lung function in patients with COPD following oral dosing of IMD-1041 • To determine the safety and tolerability of IMD-1041 following oral dosing in patients with COPD;Primary end point(s): Primary end-points: • IL-1ß, IL-6, TNF-a and GRO-a in blood and/or induced sputum • Total and differential white cell count in induced sputum Secondary end-points: • Safety and tolerability • CCL5, IL-8, MMP9, TIMP1, MCP-1 and MPO in induced sputum and/or blood • PAI-1 in induced sputum and PAI-1 and t-PA-PAI complex in blood • Lung function assessments | — |
Countries
United Kingdom
Outcome results
None listed