| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | | Children Persistent Asthma | |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 7.0 | | E.1.2 | Level | Low | | E.1.2 | Classification code | 10003553 | |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial | | 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 | |
| E.2.2 | Secondary objectives of the trial | 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
| |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal 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 < 90% of the predicted normal value.
A FEV1 reversibility = 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
| |
| E.4 | Principal 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 < 60 % or > 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
| |
| E.5 End points |
| E.5.1 | 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 | |
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Information not present in EudraCT |
| E.6.2 | Prophylaxis | Information not present in EudraCT |
| E.6.3 | Therapy | Information not present in EudraCT |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Information not present in EudraCT |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | Information not present in EudraCT |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Information not present in EudraCT |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | Information not present in EudraCT |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description | |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.3 | The trial involves single site in the Member State concerned | Information not present in EudraCT |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 12 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 12 |
