Overview
2-arm Parallel Group Study of Fixed Combination of CHF 5993 vs Ultibro® in COPD Patients
Status:
Completed
Completed
Trial end date:
2017-07-10
2017-07-10
Target enrollment:
0
0
Participant gender:
All
All
Summary
The aim of the present study is to evaluate the superiority of the fixed triple therapy with BDP/FF/GB at a daily dose of 400/24/50 mcg respectively with that of Ultibro® Breezhaler® (DPI), fixed combination of indacaterol 85 mcg and of glycopyrronium 43 mcg in COPD patients.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Criteria
Inclusion :1. Male and female ≥ 40 years
2. Severe or very severe COPD diagnosed for at least 12 months
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. Post-bronchodilator FEV1 < 50% of the predicted normal value and a post-bronchodilator
FEV1/FVC ratio < 0.7
5. Documented history of at least one exacerbation in the 12 months
6. Patient under double therapy for at least 2 months prior to screening. Double therapy
will be defined by treatment with any of the following:
Orally inhaled corticosteroid (ICS) and (long-acting beta2-agonist) LABA ICS and
long-acting muscarinic antagonist (LAMA) Orally LABA and LAMA Monotherapy with LAMA
for at least 2 months prior to screening
7. Symptomatic patient at screening with a CAT score ≥ 10.
8. Cooperative attitude and ability to use correctly the inhalers, the spacer AeroChamber
Plus (only to patients who are using a spacer), the electronic devices with COPD
questionnaire.
Exclusion :
1. Pregnant or lactating women and all women physiologically capable of becoming pregnant
UNLESS are willing to use one or more of the reliable methods of contraception
2. Patient with a current clinical diagnosis of asthma with a physician-judged need for
inhaled or oral corticosteroid therapy
3. Patient requiring use of the following medications:
Course of systemic steroids > 3 days for COPD exacerbation in the 4 weeks prior to
screening Course of antibiotics for COPD exacerbation > 7 days in the 4 weeks prior to
screening Phosphodiesterase-4 inhibitor in the 4 weeks prior to screening Use of
antibiotics for a lower respiratory tract infection in the 4 weeks prior to screening
4. COPD exacerbation requiring prescription of systemic corticosteroids and/or
antibiotics or hospitalization during the run-in period
5. Patient treated with non-cardioselective β-blockers in the month preceding the
screening or during the run-in period.
6. Patient 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 needed
7. Patient 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
9. Patient who have clinically significant cardiovascular condition
10. Patient with atrial fibrillation (AF): Paroxysmal atrial fibrillation, Persistent,
Long standing or Permanent
11. Abnormal and clinically significant 12-lead ECG that results in active medical problem
which may impact the safety of the patient
12. Patient whose ECG shows QTcF >450 ms for males or QTcF >470 ms for females at
screening visit are not eligible (not applicable for patient with pacemaker)
13. Medical diagnosis of narrow-angle glaucoma, clinically relevant prostatic hypertrophy
or bladder neck obstruction would prevent use of anticholinergic agents
14. History of hypersensitivity to M3 Antagonists, β2-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
15. Clinically significant laboratory abnormalities indicating a significant or unstable
concomitant disease which may impact the efficacy or the safety of the study drug
16. Patients with hypokalaemia (serum potassium <3.5 mEq/L or 3.5 mmol/L) or uncontrolled
hyperkalaemia
17. Unstable concurrent disease which may impact the results of the study
18. 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
19. History of alcohol abuse or substance/drug abuse within 12 months prior to screening
visit
20. Participation in another clinical trial if investigational drug was received less than
8 weeks prior to screening visit