Chronic obstructive pulmonary disease (COPD) MedDRA version: 8.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
Conditions
Interventions
Trade Name: FOSTER
Product Name: CHF 1535 HFA pMDI
Product Code: CHF 1535 HFA
Pharmaceutical Form: Pressurised inhalation, solution
INN
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained 2. Male and female outpatients, aged = 40 years 3. Patients with a clinical diagnosis of COPD (according to GOLD guidelines) 4. FEV1 = 30% and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Female subjects: pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential (i.e. contraceptive methods other than oral contraceptives, IUD, tubal ligature) 2. Current or past diagnosis of asthma 3. History of allergic rhinitis or other atopic disease (e.g. eczema) 4. Onset of obstructive symptoms early in life (for example childhood) 5. Variability of symptoms from day to day and frequent symptoms at night and early morning (suggestive of asthma) 6. Positive FEV1 reversibility test: ?FEV1 30 minutes following inhalation of 200 µg of salbutamol pMDI more than 12% of predicted normal value [FEV1 change (L)/FEV1 predicted normal value (L) x 100] 7. A total blood eosinophil count higher than 500/µL 8. Clinically significant or unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; significant pulmonary disease (e.g. tuberculosis, lung cancer or other); cardiovascular disease (e.g. coronary artery disease, uncontrolled hypertension); gastrointestinal disease (e.g. active peptic ulcer); neurological disease; haematological disease; autoimmune disorders, or other 9. Evidence of heart failure (NYHA class III-IV) 10. Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease. 11. Patients with serum potassium levels = 3.5 mEq/L (or 3.5 mmol/L) 12. Patient with narrow-angle glaucoma 13. QTc interval (Bazett’s formula) higher than 450 msec at screening visit (Visit 1) 14. Lower respiratory tract infection within two months before screening visit (Visit 1) and during the run-in period of the study 15. Hospitalisation or emergency room treatment for an acute COPD exacerbation in the two months before screening visit (Visit 1) and during the run-in period of the study 16. Long term oxygen therapy 17. Patients treated with oral or injectable corticosteroids and antibiotics for a COPD exacerbation and/or a lower respiratory tract infection in the two months preceding the screening visit (Visit 1) and during the run-in period of the study 18. Patients treated with depot corticosteroids in the two months preceding the screening visit (Visit 1) and during the run-in period of the study 19. Changes in dose, schedule, formulation or product of a nasal corticosteroid or an oral modified-release theophylline within two months of screening visit (Visit 1) and during the run-in period of the study 20. Patients treated with long-acting antihistamines (e.g. astemizole, terfenadine) in the two months preceding the screening visit (Visit 1) and during the 52-week study period. 21. Patients treated with beta-blockers in the week preceding the screening visit (Visit 1) and during the 52-week study period 22. Patients with allergy, sensitivity or intolerance to sympathomimetic drugs or corticosteroids or to any of the excipients contained in the study drugs 23. Patients who have evidence of alcohol or drug abuse, not compliant with the study protocol or not compliant with the study tr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): · Number of COPD exacerbation · Change in pre-dose morning FEV1 from baseline to 48 weeks. ;Main Objective: To demonstrate that CHF 1535 twice daily is superior to Formoterol alone twice daily in terms of number of COPD exacerbations during 48 weeks of treatment and non-inferior to Budesonide plus Formoterol twice daily in terms of pulmonary function (change in pre-dose morning FEV1 from baseline to 48 weeks) in patients with stable severe COPD.;Secondary Objective: To assess the efficacy of the test treatment in terms of health related quality of life (HRQL), COPD symptoms, other pulmonary function parameters (FVC, PEF, FEF25-75%), use of “rescue” medication, number of moderate and severe COPD exacerbations, time to first moderate and severe COPD exacerbation, dyspnoea index, BODE index, and to evaluate the safety profile through adverse events (AEs) and adverse drug reactions (ADRs) reporting, electrocardiography, blood chemistry (serum potassium, serum cortisol and plasma glucose levels), vital signs. | — |
Countries
Italy, United Kingdom
Outcome results
None listed