Persistent moderate to severe childhood asthma (5 to 12 years of age, inclusive) MedDRA version: 8.1 Level: PT Classification code 10049585
Conditions
Interventions
Trade Name: Atimos 12 microgram pressurised inhalation solution
Product Name: Atimos
Product Code: CHF 1531 HFA
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: Formoterol fu
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent obtained by parent/legal guardian. - Boys and girls aged 5 to 12 years inclusive. - Clinical diagnosis of persistent moderate to severe asthma stable for at least 2 months, according to the Classification of Asthma Severity of the Global Initiative for Asthma, Updated 2005. - Patient on a stable dose, same formulation, of an inhaled corticosteroid (ICS) for at least 2 months before the screening visit. The daily taken dose, and also the formulation, of this inhaled corticosteroid need to remain constant throughout the study. - Patient free of an inhaled long-acting beta2-agonist (LABA) for at least 2 months before the screening visit. - Patient free of an inhaled “fixed combination” long-acting beta2-agonist plus corticosteroid pMDI or DPI for at least 2 months before the screening visit. - FEV1 greater or equal to 60% and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Intake of an investigational drug within 2 months prior to screening visit. - No or poor co-ordination of actuation and inhalation. - Inability to perform spirometry. - Unwilling, or potentially unreliable patients or patients with a history of non compliance to medical therapy. - History of malignancy or treatment for malignancy within 5 years of the screening visit. - Other significant concomitant medical condition, or paraclinical evaluation indicating a significant medical condition, which might compromise patient safety, compliance, and/or interfere with test treatments evaluation. - Seasonal asthma or asthma occurring only during episodic exposure to an allergen. - History of cystic fibrosis or bronchiectasis. - Vaccination with live-attenuated virus within 2 months of the screening visit. - Change in daily dose, dosing schedule, formulation of an inhaled corticosteroid in the previous 2 months, or during the run-in period. - Use of an inhaled long-acting beta2-agonist in the previous 2 months, or during the run-in period. - Use of an inhaled “fixed combination” long-acting beta2-agonist plus corticosteroid pMDI or DPI in the previous 2 months, or during the run-in period. - An acute asthma exacerbation in the previous 2 months, or during the run-in period. - Respiratory tract infection in the previous 2 months or during the run-in period. - Parenteral or oral corticosteroids in the previous 2 months or during the run-in period. - Use of cromolyn sodium, nedocromil, leukotriene modifiers, ketotifen, theophylline (any formulation), inhaled anticholinergics, antibiotics for a lower respiratory tract infection, oral or nebulized beta2-agonists, nebulized corticosteroids in the previous 2 months, or during the run-in period. - Intolerance or past reaction to test treatments or excipients/propellant gases. - Use of astemizole or terfenadine in the previous 2 months and use of any antihistamine during the run-in period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to demonstrate that Formoterol-HFA pMDI 12 µg with spacer (AeroChamber Plus) is clinically equivalent in terms of efficacy to Formoterol-HFA pMDI following a single dose administration in 5- to 12-year-old children with persistent moderate to severe asthma;Secondary Objective: ;Primary end point(s): Percent FEV1 change from baseline (% change in FEV1) at 3 hours post study drug | — |
Countries
Hungary
Outcome results
None listed