E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Persistent moderate to severe childhood asthma (5 to 12 years of age, inclusive) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10049585 |
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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 |
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 |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 < 80% of the predicted normal value.
- If the patient has not respected the conventional wash-out of 8 hours for short-acting beta2-agonists at the Visit 1 and: if the FEV1 measurement is greater or equal to 80%, there is the possibility to take into account a previous FEV1 measurement for his enrolment in the run-in period. This one has to be greater than or equal to 60% and < 80% performed during the last month. In such a case, FEV1 will be retested at Visit 2 after a conventional short-acting beta2-agonist treatment wash-out. If the FEV1 is still again greater or equal to 80% of the predicted normal value the patient will not be randomised to treatments; in such a case only, if the change in FEV1 is less than 12% at Visit 1, this criterion will need to be met before Visit 2, after a conventional 8-hour wash-out.
- A change in FEV1 from (pre-salbutamol) baseline value greater than or equal to 12%, 30 minutes following inhalation of 200 µg of salbutamol pMDI.
- A cooperative attitude and ability to be trained in the proper use of a pMDI and spacer (AeroChamber Plus).
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percent FEV1 change from baseline (% change in FEV1) at 3 hours post study drug |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
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 |
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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
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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 | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 5 |