CHRONIC OBSTRUCTIVE PULMONARY DISEASE MedDRA version: 16.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: CHF 5259 pMDI
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: GLYCOPYRRONIUM BROMIDE
CAS Number: 596-51-0
Current Sponsor code: CHF 5259
Concentration unit: µg
Sponsors
CHIESI FARMACEUTICI SPA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female adults (40 = age = 80 years) with written informed consent obtained prior to any study-related procedure. 2. Patients with a diagnosis of COPD at least 12 months before the screening visit (according to GOLD guidelines, revised February 2013). 3. Current smokers or ex-smokers who quit smoking at least 6 months prior to the screening visit. 4. A post-bronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Inability to carry out pulmonary lung function testing, to comply with study procedures or with study treatment intake. 2. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are willing to use one or more of the reliable methods of contraception. 3. Diagnosis of asthma or medical history of asthma. 4. Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN. 5. Use of antibiotics for a lower respiratory tract infection in the 4 weeks prior to screening and during run-in period. 6. Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia. 7. Known respiratory disorders other than COPD which may impact the efficacy or the safety of the study drug according to investigator's judgement. 8. Patients who have a clinically significant cardiovascular condition according to investigator's judgement 9. Patient with persistent, long standing persistent or permanent atrial fibrillation. 10. An abnormal and clinically significant 12-lead ECG which may impact the safety of the patient according to investigator's judgement. 11. Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic agents. 12. History of hypersensitivity to anticholinergics, ß2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial which may raise contra-indications or impact the efficacy of the study drug according to the investigator's judgement. 13. Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study drug according to investigator's judgement. 14. Patients with serum potassium levels 5.5 mEq/L (or 5.5 mmol/L). 15. Unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; uncontrolled gastrointestinal disease (e.g. active peptic ulcer); uncontrolled neurological disease; uncontrolled haematological disease; uncontrolled autoimmune disorders, or other which may impact the efficacy or the safety of the study drug according to investigator's judgment. 16. History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit. 17. Participation in another clinical trial where investigation drug was received less than 8 weeks (or 5 half-lives for biologic products with slow elimination) prior to screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of CHF 5259 pMDI versus placebo in terms of change from baseline in pre-dose morning FEV1 on Day 28.;Secondary Objective: To evaluate the effect of CHF 5259 pMDI in terms of FEV1 AUC0-12h normalised by time on Day 28. To evaluate the effect of CHF 5259 pMDI on other lung function parameters, patient’s health status (symptom scores) and on clinical outcome measures. To assess the safety and tolerability of the study treatment.;Primary end point(s): Change from baseline in pre-dose morning FEV1 on Day 28;Timepoint(s) of evaluation of this end point: DAY 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): FEV1 AUC0-12h normalised by time on Day 28; change in other lung function parameters (trough and peak FEV1, FVC, IC,TDI score, SGRQ score, rescue medication intake).;Timepoint(s) of evaluation of this end point: DAY 1 AND/OR DAY 28 | — |
Countries
Bulgaria, Germany, United Kingdom
Contacts
Public ContactCLINICAL PROJECT MANAGER
CHIESI FARMACEUTICI SPA
Outcome results
None listed