Asthma MedDRA version: 16.1 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
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 5534-09-8
Current Sponso
Sponsors
Chiesi Farmaceutici SpA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written informed consent obtained from the parents/legal representatives and/or the subject (if and when appropriate) 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.Endocrinological diseases or other chronic diseases. 2.Known sensitivity to the components of study medication. 3.Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids. 4.Allergy to one component of medications used. 5.Intolerance or contra-indication to treatment with 2-agonists and/or inhaled corticosteroids. 6.Having received an investigational drug within 2 months before the current study. 7.Inability to comply to study procedures or to study treatment intake. 8.Occurrence of acute asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening visit. 9.Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer. 10.History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency. 11.History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit). 12.Diagnosis of restrictive lung disease. 13.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. 14.QTc interval (Fridericia’s formula) higher than 450 msec at screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority in terms of bronchodilator effect of single administration of CHF 1535 50/6 pMDI (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose, 2 inhalations, total dose 100/12 µg) given with spacer vs. free combination of extrafine beclomethasone dipropionate 50 µg/metered dose pMDI (2 inhalations, total dose 100 µg) given with spacer plus formoterol 6 µg/metered dose pMDI (2 inhalations, total dose 12 µg) given with spacer in terms of FEV1 AUC 0-12 hours corrected by time for the 12 hours study period in asthmatic children;Secondary Objective: -to compare the effect of the fixed combination CHF 1535 (total dose: BDP 100 µg / FF 12 µg) and of the free combination, both given with spacer, over placebo; -to explore the dose-related efficacy of the fixed combination CHF 1535; -to evaluate the safety profile of the study treatments ;Primary end point(s): FEV1 AUC corrected by time measured over 12 hours (15 min pre-dose and 10 min, 30 min, 1, 2, 4, 6, 8, 10, 12 hours post-dose) following the morning dose of study medication ;Timepoint(s) of evaluation of this end point: V2,V3,V4,V5,V6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Peak FEV1 -FEV1 at 12h post-dose -Adverse events and adverse drug reactions. -Heart rate, systolic and diastolic blood pressure in sitting position, pre-dose and 30 min post-dose at each treatment visit. -12-lead ECG (including QTc interval corrected by Fridericia’s formula), 15 min pre-dose and 30 min, 1, 2, 6, 12 hours post-dose ;Timepoint(s) of evaluation of this end point: V2(W1),V3(W2),V4(W3),V5(W4),V6(W5) | — |
Countries
Poland, Ukraine
Contacts
Public ContactGuido Varoli
Chiesi Farmaceutici SpA
Outcome results
None listed