Children Persistent Asthma MedDRA version: 7.0 Level: Low Classification code 10003553
Conditions
Interventions
Trade Name: Atismos 12µg pressurised inhalation solution 120 actuations
Product Name: Formoterol Fumarate
Product Code: CHF 1531
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed I
Sponsors
Chiesi Farmaceurtici S.p.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Boys and girls aged of 5 to 12 years inclusive and whose parents or guardians give written informed consent Clinical diagnosis of persistent asthma Patients on a stable dose of inhaled corticosteroids for at least one month before the screening visit and use of short-acting beta 2-agonists (SABAs) on at least two days in the week prior to screening and/or with clinical symptoms during at least two days (consecutive or not) in the week prior to screening visit. The daily dose of inhaled corticosteroids should be in the following ranges: - 100 - 400 µg of budesonide-DPI - 100 - 500 µg of CFC-beclomethasone dipropionate - 50 - 200 µg of HFA-ultrafine beclomethasone -100 - 250 µg of fluticasone Patients free of long-acting b2-agonists treatment (LABAs) at least for one month before the screening visit FEV1 = or > 60% and = or 12 % over baseline, after 15 minutes following inhalation of 200 µg of salbutamol A cooperative attitude and ability to be trained in the proper use of a pMDI and DPI Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Having received an investigational drug within 2 months before the current study Lacking the motor skills (co-ordination of actuation and inhalation) Inability to perform outcome measurements optimally Inability for patients/parents/guardians to fill in diary-cards Potentially unreliable patients or patients with a history of noncompliance to medical therapy Children whose parents/guardians don’t give written informed consent History of malignancy or treatment for malignancy within 5 years Significant medical condition or laboratory profile that might compromise patient safety, compliance, interfere with evaluation Seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer History of cystic fibrosis or bronchiectasis Clinically significant cardiac, renal, neurological, hepatic, endocrine or any concomitant diseases which could interfere with the protocol according to investigator’s opinion Vaccination with live-attenuated virus within one month of screening visit Children with an abnormal QTc interval value defined as > 460 msec FEV1 90 % of predicted normal value A FEV1 reversibility < 12 % over baseline, after 15 minutes following inhalation of 200 µg of salbutamol Hospitalization or acute asthma exacerbation in the 2 months preceding the screening visit Respiratory tract infection, excluding sinusitis, in the month preceding the screening visit Allergy to one component of medications used (formoterol fumarate, tetrafluoroethane-134a, anhydrous ethanol and hydrochloric acid and lactose). History of side effects (intolerance) to any of the pMDI and DPI ingredients Parenteral or oral corticosteroids in the previous 4 weeks (3 months for slow-release corticosteroids). Any change in dose, schedule, formulation or product of inhaled corticosteroids, cromolyn sodium, nedocromil, antihistaminics, leukotriene antagonists within one month of screening visit. Theophylline (except oral sustained-release theophylline). Astemizole or terfenadine Treatment with non-potassium sparing diuretics, beta-blocking drugs, quinidine, quinidine-like anti-arrythmics, tricyclic anti-depressants, fluoxetine or MAO inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy and safety of 12 µg of formoterol-HFA b.i.d versus 12 µg of formoterol-DPI b.i.d over a 12-week treatment period in asthmatic children 5 to 12 years old with persistent asthma requiring regular inhaled corticosteroids treatment;Secondary Objective: predose evening PEF, daily PEF variability, FEV1, FVC, FEV1/FVC, PEF (measured at each visit), FEF25%, FEF25-75%, FEF75% Asthma symptoms Rescue medication use Adverse events and adverse drug reactions evaluation Heart rate (HR), systolic and diastolic blood pressure 12 lead ECG with QT interval corrected by Bazett’s formula Serum potassium and blood glucose levels ;Primary end point(s): The predose morning PEF at the end of the treatment period calculated as the mean of the last 7 values obtained during the two last weeks of the treatment period, and expressed as change from baseline | — |
Countries
Czech Republic
Outcome results
None listed