A study to compare the single administration of a product called CHF 1535 (two medicines together for the treatment of asthma) and the same two single medicines, measuring the air contained in the lungs in asthmatic childre

Conditions: Asthma
MedDRA version: 16.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2011-002060-24-PL

Lead Sponsor: Chiesi Farmaceutici SpA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

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 < 12 years (Tanner stage I and II)
3.Clinical diagnosis of asthma according to Global Strategy for Asthma Management and Prevention (GINA) revised version 2009 at least six months prior to screening visit.
4.Already treated with inhaled beclomethasone dipropionate up to 400 µg or equivalent at stable dose for at least 4 weeks prior to screening visit and inhaled short acting ß2-agonists on an as needed basis.
5.Forced Expiratory Volume during the first second (FEV1) = 60% and = 95% of predicted normal values at the screening visit.
6.A documented positive response to the reversibility test at the screening visit, defined as ?FEV1 = 12% over baseline, 15 minutes after 200 µg salbutamol pMDI (ATS/ERS taskforce 2005).
7.A cooperative attitude and ability to use a pMDI and a spacer (AeroChamber Plus™).

Are the trial subjects under 18? yes
Number of subjects for this age range: 100
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

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