Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 18.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Glycopyrronium bromide 25µg NEXThaler
Product Code: CHF 5259
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: GLYCOPYRRONIUM BROMIDE
CAS Number: 596-51-0
Current Sponsor code:
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged = 40 years at screening visit, who have signed an Informed Consent form prior to initiation of any study-related procedure. 2. Patients with a diagnosis of COPD (according to GOLD guidelines 2015) at least 12 months before screening visit. 3. Current smoker or ex-smoker with a smoking history of at least 10 pack-years defined as [(number of cigarettes smoked per day) × (number of years of smoking)] / 20. (If the subjects undergo smoking cessation therapy, it must be completed 3 months prior to the screening visit. Smoking cessation must be at least 3 months prior the screening. In both cases the smoking status should not change between the subjects screening visit and subjects last study visit). 4. A post-bronchodilator FEV1 = 40% and =70% of the predicted normal value (measured 30 to 45 minutes after administration of 80 µg ipratropium pMDI) and, - a post-bronchodilator FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Diagnosis of asthma or other respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigator’s opinion. 2. Patients had a COPD exacerbation or a lower respiratory tract infection within 8 weeks prior to screening, or during the run-in period, that resulted in the use of an antibiotic, or oral or parenteral corticosteroids, or hospitalisation. 3. Patients with a history of = 2 exacerbations within the last 12 months prior to screening (frequent exacerbators). 4. Patients treated with oral/parenteral ß2-agonists or nebulised bronchodilators or PDE inhibitors or who received LABA/LAMA/ICS treatment therapy in the 4 weeks prior to screening and during the run-in period. 5. Patient is on an inhaled corticosteroid that has been initiated, or the effective dose has been changed, within 4 weeks prior to screening or during the run-in period (patients on stable dose of ICS for at least 4 weeks prior to screening are allowed). 6. Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia. 7. Patients with known respiratory disorders other than COPD. 8. Patients with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic. 9. Patients who have unstable concurrent disease, that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study; 10. Patients who have a concomitant disease of poor prognosis 11. Patients who have clinically significant cardiovascular condition 12. Patients with known atrial fibrillation (AF): a. Paroxysmal Atrial Fibrillation b. Persistent: AF episode lasting more than 7 days or requiring termination by cardioversion, either with drugs or by direct current cardioversion (DCC) within 6 months prior to screening visit. c. Long standing persistent: continuous atrial fibrillation diagnosed for less than 6 months and/ or without a rhythm control strategy. d. Permanent: AF diagnosed for at least 6 months with a resting ventricular rate = 100/min not controlled with a rate control strategy (i.e., selective ß-blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy). 13. Patients have a clinically significant abnormal 12-lead ECG that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study. 14. Patients whose electrocardiogram 12-lead ECG shows a QTcF>450 ms for males or QTcF > 470 ms for females. 15. Patients with clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study. 16. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they are willing to use a highly effective birth control methods such as : a. Placement of an intrauterine device or intrauterine releasing system b. Oral, intravaginal, transdermal combined estrogen and progestogen containing hormonal contraception or oral, injectable, implantable progestogen only hormonal contraception. c. Bilateral tubal occlusion d. Partner vasectomy (provided that partner is the sole sexual partner of the WOCBP tria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to identify the optimal dose of CHF 5259 glycopyrronium bromide (GB) to be further developed for the treatment of patients with COPD.;Secondary Objective: To evaluate the effect of CHF 5259 glycopyrronium bromide (GB) on lung function parameters. To assess the safety of the study treatments.;Primary end point(s): FEV1 AUC 0-12h normalised by time;Timepoint(s) of evaluation of this end point: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): EFFICACY VARIABLES: FEV1, FVC, Transition Dyspnoea Index (TDI) SAFETY VARIABLES: Adverse events and adverse drug reactions Vital signs, ECG and laboratory;Timepoint(s) of evaluation of this end point: Day 1, day 14 and/or day 28, and across the study for safety variables | — |
Countries
Czech Republic, Germany, Hungary
Contacts
Public ContactClinical Project Manager
Chiesi Farmaceutici S.p.A.
Outcome results
None listed