Asthma MedDRA version: 14.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: CHF 1535 50/6 µg pMDI
Product Code: CHF 1535 50/6 µg pMDI
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 5534-09-8
Curr
Sponsors
Chesi Farmaceutici SpA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained from the parents/legal representatives (according to the local regulation) and written or verbal assent by the patient (when appropriate) prior to any study related procedures. For France: only patients registered under a social welfare can be included in the study. 2. Prepuberal male and female outpatients, aged = 5 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with two or more admissions to hospital for asthma exacerbation in the past 12 months or any admission to intensive care ever. 2. Any concomitant disease requiring additional treatment with systemic glucocorticosteroids. 3. Regular use of anticholinergics. 4. Allergy to one component of medications used. 5. Intolerance or contra-indication to treatment with ß2-agonists and/or inhaled corticosteroids. 6. Having received an investigational drug within 2 months before the current study. 7. Patients and/or parents unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments. 8. Occurrence of acute asthma exacerbations or lower respiratory tract infections in the 4 weeks preceding the screening visit or during the run-in period. 9. History of cystic fibrosis, bronchiectasis, primary ciliary dyskinesia, bronchopulmonary dysplasia, or previous premature children with less than 36 weeks of gestational age. 10. History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit). 11. Diagnosis of restrictive lung disease. 12. Significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient’s safety, compliance, or study evaluations, according to the investigator’s opinion. 13. QTc interval (Fridericia’s formula) higher than 450 msec (for boys) and 470 msec (for girls) at screening visit and randomisation visit. 14. Current smokers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that CHF 1535 50/6 µg pMDI (daily dose: BDP 200 µg/FF 24 µg) is superior to the corresponding monotherapy with beclomethasone dipropionate 50 µg pMDI (daily dose: BDP 200 µg) and non-inferior relative to the corresponding free combination of beclomethasone dipropionate 50 µg pMDI (daily dose: BDP 200 µg) plus formoterol fumarate 6 µg pMDI (daily dose: FF 24 µg) (all treatments administered via the AeroChamber Plus™ spacer device) in terms of pulmonary function (change from baseline in pre-dose morning FEV1 after a 12-week treatment period) in children patients with “partly controlled” persistent asthma;Secondary Objective: - To evaluate the effect of the treatments on additional lung function parameters and on clinical outcome measures; - To assess the safety and the tolerability of the administered treatments;Primary end point(s): Change from baseline to end of treatment (Week 12, V5) in pre-dose morning FEV1 (L).;Timepoint(s) of evaluation of this end point: V2 (week 0) and V5 (week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - change from baseline in pre-dose morning FEV1 and FVC at each clinic visit; - mean change from baseline in pre-dose morning FEV1 and FVC; - change from baseline in pre-dose morning and evening PEF (measured with electronic manual spirometer); - change from baseline in daily PEF variability; - change from baseline in daytime and night-time asthma symptom scores; - change from baseline in percentage of symptom-free days; - change from baseline in daytime and night-time use of rescue salbutamol (number of inhalations); - change from baseline in percentage of rescue salbutamol-free days; - change from baseline in percentage of asthma control days. - change from baseline in Standardised Paediatric Asthma Quality of Life Questionnaire (PAQLQ(S)) score; - number of asthma exacerbations, number of patients with asthma exacerbations and asthma exacerbation rate; - FeNO parameter expressed as percentage of baseline (as explorative evaluation in a subgroup of 10% of patients in pre-selected centres). - Adverse events and adverse drug reactions. - Heart rate, systolic and diastolic blood pressure in sitting position, pre-dose (V1 to V5) and 30 min post-dose at each visit (V2 to V5). - Standard haematology and blood chemistry at V2 and V5. - 12-lead ECG (including QTc interval corrected by Fridericia’s formula), pre-dose at V1, pre-dose and 30 min post-dose at V2 and V5. - 12-hour overnight urinary free cortisol/creatinine ratio at V2 and V5.;Timepoint(s) of evaluation of this end point: Secondary efficacy end points will be evaluated at study visits according to the schedule of assessment reported in the study protocol. PAQLQ, Routine haematology and blood chemistry and FeNO test will be evaluated at V2 (week =) and V5 (week12). 12-lead ECG will be evaluated at V1 (week -2), V2 (week 0) and V5 (week 12) | — |
Countries
Bulgaria, Germany, Hungary, Italy, Russian Federation, Spain, Ukraine
Contacts
Public ContactFlorence Zuccaro
Chiesi Farmaceutici SpA
Outcome results
None listed