Mild asthma in children (males and females) 6-14 years MedDRA version: 9.1 Level: LLT Classification code 10049585 Term: Infantile asthma
Conditions
Interventions
Trade Name: Clenil Modulite 50 or 100 microgram
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: INN beclometasone dipropionate
CAS Number: 5534-09-8
Other descriptive name:
Sponsors
Chiesi Farmaceutici S.p.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Prepuberal male and female outpatients, = 6 and = 14 years old in Tanner stadium I. 2. Written informed consent by parents/legal representatives. 3. Subject’s written informed consent (when appropriate). 4. Clinical diagnosis of mild asthma during at least two months prior to screening visit. 5. Peak Expiratory Flow (PEF) and Forced Expiratory Volume during the first second (FEV1) > 80% of predicted normal values at screening visit. 6. Treated with inhaled beta 2-agonists as required and/or inhaled dry powder Budesonide (Spirocort®) up to 400 µg daily or equivalent treatments. 7. Compliant to study procedures and able to visit the centre for controls as reported into the protocol. 8. 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: 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. Girls and boys 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 beta 2-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 compare lower leg growth rate (LLGR), measured by knemometry, over a 2-week treatment period with BDP HFA pMDI 200 µg b.i.d. using AeroChamber Plus™ spacing device versus BDP HFA pMDI 200 µg b.i.d. using Volumatic™ spacing device. The study is aiming at showing non-inferiority of BDP HFA 200 µg administered via AeroChamber Plus™ spacer vs. the same treatment administered via Volumatic™ spacer. ;Secondary Objective: Secondary objectives will be to evaluate the effects of the BDP HFA pMDI 100 µg b.i.d. versus 200 µg b.i.d., both administered via AeroChamber Plus™ spacers on the lower leg growth rate, the lower leg growth rate in each of the three active treatments versus lower leg growth rate in the single-blind placebo run-in period, the lung function measured by PEF, and the 24-hour urinary free cortisol.;Primary end point(s): The primary endpoint is the lower leg growth rate, measured by knemometry, over a 2-week treatment period with BDP HFA pMDI 200 µg bid using Volumatic Spacer versus BDP HFA pMDI 200 µg bid using AeroChamber Plus spacer. | — |
Countries
Denmark
Outcome results
None listed