Asthmatic children aged = 5 and < 12 years MedDRA version: 15.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: CHF 1535 50/6microgram pMDI
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: beclomethasone dipropionate
CAS Number: 5534-09-8
Concentration unit: µg microgram(s)
Concentrat
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Prepuberal male and female outpatients, = 5 and 80% of predicted normal values at screening visit; 5. Treated with inhaled ß2-agonists used as rescue medicaton and or beclomethasone up to 400µg daily or equivalent treatments; 6. Compliant to study procedures and able to visit the centre for controls as reported into the protocol. A cooperative attitude and ability to be trained in the proper use of a pMDI and spacers. Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) no 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. Male and female out patients in Tanner stadium II-V; 2. Endocrinological diseases including growth impairment or other chronic diseases; 3. Known sensitivity to the components of study medication; 4. Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids; 5. Allergy to one component of medications used; 6. Intolerance or contra-indication to treatment with ß2-agonists and/or inhaled corticosteroids; 7. Having received an investigational drug within 2 months before the current study; 8. Patient’s participation in another clinical trial in parallel with the present study; 9. Inability to perform outcome measurements optimally and to complete diary cards
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to show that CHF 1535 50/6µg pMDI, 2 inhalations bid (total daily dose: BDP 200µg / FF 24µg) using AeroChamber Plus™ spacer device is non-inferior to a corresponding free combination of BDP 50µg pMDI, 2 inhalations bid (total daily dose: 200µg) plus FF 6µg pMDI, 2 inhalations bid (total daily dose: 24µg) using AeroChamber Plus™ spacer device in terms of lower leg growth rate (LLGR), measured by knemometry, over a 2-week treatment period;Secondary Objective: To demonstrate that CHF 1535 50/6 pMDI is non-inferior to a corresponding free combination dose of extrafine BDP 50µg HFA plus Formoterol Fumerate (FF) 6µg in terms of pulmonary function test and safety parameters.;Primary end point(s): Lower Leg Growth Rate (LLGR) after 2-week treatment with CHF 1535 50/6µg pMDI and free combination of BDP 50µg pMDI plus FF 6µg pMDI will be compared using an ANCOVA model. The model will include treatment and period as fixed effects, subject as a random effect and the baseline LLGR as covariate. Baseline growth rate is the change in lower leg length from beginning to end of run-in period, divided by the time interval between the two measurements. The difference between treatments for adjusted treatment means will be presented with a two-sided 95% confidence interval. If the lower bound of this interval is greater than or equal to -0.20 mm/week non inferiority will be declared. ;Timepoint(s) of evaluation of this end point: End of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) LLGR after each of the two active treatments compared to LLGR at the end of placebo run-in period. An ANOVA analysis with the three treatments (two active treatments and run-in placebo) and subjects as a random effect will be performed. The results of the analysis will be presented with the estimated differences between each of the two treatments and the placebo, with a 95% confidence interval, and a p-value for the treatment difference being equal to 0. 2) The comparison of 24-hour urinary free cortisol/creatinine levels after treatment with CHF 1535 and with free combination of BDP and formoterol will be done using the same model as described in the primary endpoint analysis but without testing for non-inferiority. Consistently the comparison of 24-hour urinary free cortisol excretion/creatinine after each of the two active treatments with the end of placebo run-in period will be done with the same model used for the LLGR endpoint. 3) Incidence of adverse events (coded with MedDRA) as well as vital signs will be presented by descriptive statistics only. ;Timepoint(s) of evaluation of this end point: End of trial | — |
Countries
Denmark
Contacts
Public ContactThorbjørn Jensen
Cyncron A/S
Outcome results
None listed