COPD patients MedDRA version: 16.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Foster®
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 5534-09-8
Other descriptive name: BDP
Concentration unit: µg micr
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female adults (= 40 and = 75 years old). 2. Female subjects must either be of non-childbearing potential, using at least one acceptable method of contraception or sexually abstinent, from screening until the end of the study. 3. Written informed consent obtained by the patient prior to any study-related procedures. 4. Outpatients with diagnosis of moderate/severe stable COPD, according to GOLD guidelines update 2013 at least in the 6 months before the screening visit. 5. A post-bronchodilator FEV1 = 40 and =65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating female subjects. 2. Current diagnosis of Asthma. 3. Hospitalization for COPD or pneumonia within 3 months prior to screening and until randomization. 4. COPD exacerbations requiring systemic steroids and /or antibiotics and/or oral or nebulized ß2-agonists in the 4 weeks prior to screening and until randomization. 5. LRTI in the 4 weeks prior to screening and until randomization. 6. Patients with serum potassium levels 3); acute ischemic heart disease within the past 12 months of screening; Sustained cardiac arrhythmias (supraventricular or ventricular, >30 seconds duration) at or within 6 months of screening; Non sustained cardiac arrhythmias (supraventricular or ventricular, > 3 beats < 30 seconds and or ending spontaneously and or asymptomatic); History of sustained and non-sustained cardiac arrhythmias (supraventricular or ventricular); 2nd or 3rd degree AV conduction block; Left Bundle Branch Block. 12. Known respiratory disorders other than COPD 13. Patients whose DBP/SBP is higher than: DBP 90 mmHg or SBP 160 mmHg at screening or at randomization. 14. Patients taking Cardiac Anti-Arrythmics drugs, chronically or in the 4 weeks preceding the Screening Visit, patients taking oral/IV/IM corticosteroids, oral or nebulized ß2-agonists and/or antibiotics for LRTI and xanthine derivative (e.g. theophylline) formulations in the 4 weeks preceding the screening visit. 15. Unstable concurrent disease 16. Any patient with active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of the skin is acceptable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the average heart rate over 4 hours after administration of BDP and Formoterol using CHF 1535 100/6 NEXThaler® DPI and CHF 1535 100/6 pMDI at two different dose levels;Secondary Objective: • To evaluate the effects of both formulations on serum potassium and serum glucose and cardiovascular parameters • To assess the safety and the tolerability of the study treatments ;Primary end point(s): Average 4-hour Heart Rate;Timepoint(s) of evaluation of this end point: 4-hour rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cardiovascular: • Average Hourly HR 0-1hr, 1-2hr, 2-3hr, 3-4hr • Maximum 4-hour Heart Rate • Average 0-12 hour Heart Rate • Heart Rate at 5 minutes post-dose (expected time of Formoterol Cmax) • QTcF, PR, QRS • PAC burden • PVC burden • Blood Pressure: SBP AUC0-12h/12h, DBP AUC0-12h/12h Metabolic response: • Serum Potassium (AUC0-4h, Cmin, tmin) • Serum Glucose (AUC0-4h, Cmax, tmax) ;Timepoint(s) of evaluation of this end point: See section E.5.2 | — |
Countries
United Kingdom
Contacts
Public ContactGiorgia Ciurlia
Chiesi Farmaceutici S.p.A.
Outcome results
None listed