A MULTINATIONAL, MULTICENTRE, RANDOMISED, OPEN-LABEL, ACTIVE-CONTROLLED, 26-WEEK, 2-ARM, PARALLEL GROUP STUDY TO EVALUATE THE NON-INFERIORITY OF FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE ADMINISTERED VIA PMDI (CHF 5993) VERSUS FIXED COMBINATION OF FLUTICASONE FUROATE PLUS VILANTEROL ADMINISTERED VIA DPI (RELVAR*) PLUS TIOTROPIUM BROMIDE (SPIRIVA®) FOR THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
- Conditions
- COPDairflow obstruction10006436
- Registration Number
- NL-OMON41888
- Lead Sponsor
- Chiesi Farmaceutici
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 84
Patients must meet all of the following inclusion criteria to be eligible for enrolment into the study:
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 [pack-years = (number of cigarettes per day x number of years)/20].
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.
If this criterion is not met at screening, the test can be repeated once before randomisation.
5. A documented history of at least one exacerbation in the 12 months preceding the screening visit.
COPD exacerbation will be defined according to the following:
*A sustained worsening of the patient*s condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD that includes prescriptions of systemic corticosteroids and/or antibiotics or need for hospitalization*
Also documented visits to an emergency department due to COPD exacerbation are considered acceptable to fulfil this criterion.
6. Patients under double therapy for at least 2 months prior to screening visit with either:
a. inhaled corticosteroids/long-acting β2-agonist combination (fixed or free), without regular use of short-acting muscarinic antagonist (regular use means 2 puffs 4 times per day at least) or
b. inhaled corticosteroids/long-acting muscarinic antagonist free combination, without regular use of short-acting β2-agonist (regular use means 2 puffs 4 times per day at least) or
c. Inhaled long-acting β2-agonist and inhaled long-acting muscarinic antagonist or
Patients under monotherapy with long-acting muscarinic antagonist for at least 2 months prior to screening.
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.
At screening visit (V1), all inclusion criteria will be checked.
At randomisation visit (V2), criteria 8 and 9 will be re-checked.
The presence of any of the following will exclude a patient from study enrolment:
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 of the following reliable methods of contraception:
a. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
b. Hormonal contraception (implantable, patch, oral, injected).
c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical vaults/caps) with spermicidal foam/gel/film/cream/suppository.
d. Male sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
Reliable contraception should be maintained throughout the study until the last study visit.
*True abstinence* is acceptable only if it is in line with the preferred and usual lifestyle of the patient.
Pregnancy testing will be carried out during the course of the study in all women of childbearing potential: serum pregnancy test will be performed at screening and end of treatment, urine pregnancy test will be performed at all clinic visits except the last one.
Any postmenopausal women (physiologic menopause defined as *12 consecutive months of amenorrhea*) or women permanently sterilized (e.g. tubal occlusion, hysterectomy or bilateral salpingectomy) can be enrolled in the study.
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 the following medications:
a. A course of systemic steroids longer than 3 days for COPD exacerbation in the 4 weeks prior to screening.
b. A course of antibiotics for COPD exacerbation longer than 7 days in the 4 weeks prior to screening.
c. PDE4 inhibitors in the 4 weeks prior to screening.
d. Use of antibiotics for a lower respiratory tract infection (e.g pneumonia) 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 β-blockers in the month preceding the screening visit or during the run-in period. Those patients may enter the study after non-selective β-blockers withdrawal and/or cardio selective β-blockers intake 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. This can include but is not limited to *-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease.
9. Patients who have clinically significant cardiovascular condition such as, but not limited to, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, acute ischemic heart disease in the last year prior to study screening, history of sustained cardiac arrhythmias or sustained and non-sustained cardiac arrhythmias diagnosed in the last 6 months (sustained means lasting m
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change from baseline in the SGRQ total score at Week 26.</p><br>
- Secondary Outcome Measures
Name Time Method