Bronchial Asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: FOSTER®
Product Name: Foster® 100/6
Product Code: CHF 1535 HFA pMDI
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: Beclometasone dipropionate
CAS Number: 5534-0
Sponsors
Chiesi Farmaceutici SpA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained 2. Adult male and female (=18 and =65 years) 3. Clinical diagnosis of Asthma according to Global Strategy for Asthma management and Prevention (GINA) revised version 2007 4. Patients treated with inhaled corticosteroids equivalent to Budesonide 200 µg b.i.d. (with or without LABA), including fixed combination 5. FEV1 = 65% of the predicted normal value pre-bronchodilator 6. A documented positive response to the reversibility test, defined as an improvement in FEV1 of at least 12% from baseline value and 200 ml 30 minutes after 4 puffs of inhaled salbutamol pMDI (400 µg) at screening or within a year prior to screening and/or documented hyper-responsiveness to methacholine on bronchial challenge testing 7. FENO > 30 ppb at screening. If this test fails, it can be repeated once (Screening Visit 1 rescheduled within 7 days. In this case, only NO measurement will be re-performed) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Inability to carry out pulmonary function testing and NO testing; 2. Diagnosis of COPD as defined by the current GOLD guidelines (2006); 3. History of near fatal asthma; 4. Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 8 weeks; 5. More than two courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months; 6. Current smokers or recent (less than one year) ex-smokers defined as smoking more than 10 pack-years; 7. Clinically significant or unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; significant other pulmonary disease; cardiovascular disease; gastrointestinal disease; neurological disease; haematological disease, autoimmune disorders, that may interfere with patient’s safety, compliance, or study evaluations, according to the investigator’s opinion; 8. Cancer or any chronic diseases with prognosis < 2 years; 9. Female subjects: pregnant or with active desire to be 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). A pregnancy test in urine is to be carried out in women of a fertile age at screening; 10. Significant alcohol consumption or drug abuse; 11. Patients treated with leukotrien modifiers, inhaled long-acting and shortacting anticholinergics, monoamine oxidase inhibitors or beta-blockers as regular use 12. Patients treated with tricyclic antidepressants or Selective Serotonin Reuptake Inhibitors (SSRIs) unless already taken at stable doses at the screening visit; 13. Patients treated with extrafine formulations of ICS or fixed combinations of ICS and LABA 14. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients; 15. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; 16. Patients who received any investigational new, not yet approved drugs within the last 8 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of BDP and Formoterol administered as extrafine fixed combination pMDI (Foster®), in comparison with the fixed combination of Budesonide and Formoterol (Symbicort Turbohaler), on small airways, by measuring alveolar nitric oxide and lung resistance in asthmatic patients.;Secondary Objective: • to evaluate the lung reactance (Xrs) • to compare the treatment effects on respiratory functions and nitric oxide and on inflammation biomarkers in sputum • to assess the safety and tolerability;Primary end point(s): After the 4-week treatment the following parameters will be evaluated: • Alveolar NO concentration (Calv, ppb) • IOS ?R5-R20 | — |
Countries
Germany
Outcome results
None listed