Bronchodilator Effect of CHF1535 pMDI Versus Free Combination of Beclometasone Plus Formoterol pMDI in Asthmatic Children

Launched by CHIESI FARMACEUTICI S.P.A. · Apr 24, 2012

Keywords

ClinConnect Summary

FEV1 from 0 to 12 hours standardised by time will be statistically analysed taking into account treatment, period and subject and pre-dose FEV1.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written informed consent obtained from the parents/legal representatives and/or the subject (if and when appropriate)
• • Prepuberal male and female outpatients, aged ≥ 5 and \< 12 years (Tanner stage I and II)
• • 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.
• • Already treated with inhaled short acting Beta2-agonists as required and / or inhaled beclomethasone dipropionate up to 400 µg or equivalent.
• • Forced Expiratory Volume during the first second (FEV1) ≥ 60% and ≤ 95% of predicted normal values at the screening visit.
• • A documented positive response to the reversibility test at the screening visit, defined as Delta FEV1 ≥ 15% over baseline, 15 minutes after 400 μg salbutamol pressurised Meter Dose Inhaler (ATS/ERS taskforce 2005).
• • A cooperative attitude and ability to use a pMDI and a spacer (Aerochamber Plus and Volumatic).
• Exclusion Criteria:
• • Endocrinological diseases or other chronic diseases.
• • Known sensitivity to the components of study medication.
• • Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids.
• • Allergy to one component of medications used.
• • Intolerance or contra-indication to treatment with Beta2-agonists and/or inhaled corticosteroids.
• • Having received an investigational drug within 2 months before the current study.
• • Inability to comply to study procedures or to study treatment intake.
• • Occurrence of acute asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening visit.
• • Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
• • History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
• • History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit).
• • Diagnosis of restrictive lung disease.
• • 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.
• • QTc interval (Fridericia's formula) higher than 450 msec at screening visit