A study to evaluate whether a new inhaled medicine (combination of beclometasone plus formoterol plus glycopyrronium) works as well as a combination of licensed medicines (combination of fluticasone plus vilanterol and tiotropium) in patient with chronic obstructive pulmonary disease.
- Conditions
- Chronic Obstructive Pulmonary DiseaseMedDRA version: 18.0Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-001487-35-BE
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1142
1. Male and female adults aged = 40 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 document updated 2014).
3. Current smokers or ex-smokers who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years
4. A post-bronchodilator FEV1 < 50% of the predicted normal value and a post-bronchodilator FEV1/FVC < 0.7 at least 10-15 min after 4 puffs (4 x 100 µg) of salbutamol pMDI.
5. A documented history of at least one exacerbation in the 12 months preceding the screening visit.
6. Patients under double therapy for at least 2 months prior to screening visit of an inhaled corticosteriod (ICS) plus a long-acting muscarinic antagonist (LAMA) or long-acting ß2-agonist (LABA) or a double combination of LABA/LAMA or LAMA alone
7. Symptomatic patients at screening with a CAT score =10.
8. A cooperative attitude and ability to use correctly the inhalers.
9. A cooperative attitude and ability to use correctly the daily eDiary.
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 800
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 342
1. 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 methods of contraception as defined in the protocol
2. Patients with a current clinical diagnosis of asthma with a physician-judged need for inhaled or oral corticosteroid therapy
3. Patients requiring use of systemic steroids, antibiotics, PDE4 inhibitors in the 4 weeks prior to screening
4. COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period
5. Patients treated with non-cardio selective ß-blockers for at least 10 days before randomization
6. 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.
7. Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
8. Known respiratory disorders other than COPD which may impact the efficacy of the study drug according the investigator’s judgment
9. Patients who have clinically significant cardiovascular condition
10. Patients with atrial fibrillation (AF)
11. An abnormal and clinically significant 12-lead ECG which may impact the safety of the patient according to investigator’s judgement
12. 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
13. 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
14. 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
15. Patients with hypokalaemia or uncontrolled hyperkalaemia according to investigator’s judgment
16. Unstable concurrent disease which may impact the efficacy or the safety of the study drug according to investigator’s judgment.
17. Patients with any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next six months (after V1) or with malignancy for which they are currently undergoing radiation therapy or chemotherapy
18. History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit
19. Participation in another clinical trial where investigation drug was received less than 8 weeks prior to screening visit
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the non-inferiority of CHF 5993 pMDI versus fixed combination of fluticasone furoate/vilanterol plus tiotropium in terms of quality of life (change from baseline in the St. George’s Respiratory Questionnaire [SGRQ] total score after 26 weeks of treatment). ;Secondary Objective: • To evaluate the effect of CHF 5993 pMDI on lung function parameters, patient’s health status and on clinical outcome measures.<br>• To collect data in order to assess the impact of study treatments on health economic outcomes.<br>• To assess the safety and tolerability of the study treatments.<br>;Primary end point(s): Change from baseline in the SGRQ total score;Timepoint(s) of evaluation of this end point: Visit 2 (week 0) to visit 5 (week 26)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • SGRQ response (change from baseline in total score = -4) <br>• Change from baseline in the SGRQ total score <br>• Change from baseline in pre-dose morning FEV1, FVC and FEV1 response<br>• Change from baseline of night-time COPD symptoms on sleep <br>• Use of rescue medication <br>• CAT score at the end of treatment<br>• Rate of moderate and severe COPD exacerbation over 26 weeks of treatment.;Timepoint(s) of evaluation of this end point: Study duration