COPD
Conditions
Interventions
A 2-week open-label run-in period under tiotropium followed by a 26-week
open-label, randomised treatment period.
Test product dose/route/regimen
CHF 5993 pMDI: Fixed combination of beclometasone d
Sponsors
Chiesi Farmaceutici
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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 =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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the SGRQ total score at Week 26. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary efficacy variable • SGRQ response (change from baseline in total score = 100 ml) at Week 26. • Change from baseline in pre-dose morning FVC at all clinic visits. • Change from baseline to each inter-visit period and the entire treatment period in the percentage of days without nocturnal awakenings due to COPD, in the average impact of night-time COPD symptoms on sleep and in the average impact of night-time COPD symptoms on patient*s ability to get up in the morning (impacts evaluated daily on a 7-point Likert scale and averaged over inter-visit periods). • Change from baseline to each inter-visit period and the entire treatment period in the percentage of days without intake of rescue medication and in the average use of rescue medication (number of puffs/day), distinguishing by day-time, night-time and overall intake. • CAT score at the end of treatment • Rate of moderate and severe COPD exacerbation over 26 weeks of treatment. Health economic variables • EQ-5D-3L VAS score and EQ-5D-3L index at all clinic visits • Number of hospital admissions due to COPD and other causes • Number of hospital days due to COPD and other causes • Number of days in ICU due to COPD and other causes • Number of emergency room visits due to COPD and other causes • Number of ambulance rides to hospital due to COPD and other causes • Number of unscheduled contacts due to COPD: o family practitioner o specialist outpatients setting o specialist hospital outpatients setting • Number of days with professional home assistance due to COPD • Number of days with family caregivers due to COPD • Number of days with oxygen therapy use due to COPD • Unplanned diagnostic or instrumental tests performed due to COPD • Lost productivity due to COPD (sick leave days from work, anticipated retirement) • Mortality. Safety Assessments • Adverse Events (AEs) and Adverse Drug Reactions (ADRs). • Vital signs (systolic and diastolic blood pressure, pulse rate) | — |
Countries
Netherlands
Outcome results
None listed