E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003555 |
E.1.2 | Term | Asthma bronchial |
|
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 primary objective of this study is to show comparable efficacy of FlutiForm with Seretide based on mean Forced Expiratory Volume in the 1st second (FEV1) values. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives of the study are to compare peak expiratory flow rates (PEFR) and other lung function parameters, time to onset of action, amount of rescue medication use, asthma symptom scores, sleep disturbance due to asthma, amount of daily oral or parenteral corticosteroid dose, exacerbations (requiring oral/parenteral steroid use, medical intervention), subject acceptance, and spontaneously reported adverse events. Another secondary objective is to monitor the long term safety of FlutiForm during the extension phase based on the assessment of growth and plasma cortisol levels. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female subjects between 4-12 years of age. Female subjects must be pre-menarche to be eligible. 2. Known history of mild to moderate persistent asthma for at least 6 months prior to the screening visit. Subjects with mild asthma must, in the investigator’s opinion, require the use of a long acting beta2-agonist. 3. Demonstrate a FEV1 of 60% to 100% of predicted normal values (Zapletal et al., 1977) during the screening phase following appropriate withholding of asthma medications (if applicable). - No beta2-agonist use on day of screening. - No use of inhaled combination asthma therapy on day of screening. - Inhaled corticosteroids are allowed on day of screening. 4. Documented reversibility of at least 15% in FEV1 during the screening phase. 5. Demonstrate satisfactory technique in the use of the pressurised Metered Dose Inhaler (pMDI) and spacer device. 6. Willing and able to enter information in the electronic diary (parental help is acceptable) and attend all study visits. 7. Willing and able to substitute study medication for their pre study prescribed asthma medication for the duration of the study. 8. Written informed consent obtained from the parent(s)/ legal representative, and where possible informed assent from the subject (for a definition of “legal representative” see national laws). |
|
E.4 | Principal exclusion criteria |
1. Near fatal or life-threatening (including intubation) asthma within the past year. 2. Hospitalisation or an emergency visit due to asthma in the 4 weeks before the Screening Visit. 3. History of systemic (injectable) corticosteroid medication within 1 month before the Screening Visit. 4. History of leukotriene receptor antagonist use, e.g. montelukast, within the past week. 5. Current evidence or history of any clinically significant disease or abnormality including uncontrolled coronary artery disease, congestive heart failure, or cardiac dysrhythmia. ‘Clinically significant’ is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study. 6. In the investigator’s opinion, a clinically relevant upper or lower respiratory infection within 4 weeks prior to the Screening Visit. 7. Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis). 8. Known Human Immunodeficiency Virus (HIV)-positive status. 9. Current smoking history within 12 months prior to the Screening Visit. 10. Current evidence or history of alcohol and/or substance abuse within 12 months prior to the Screening Visit. 11. Subjects who have taken beta-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past week. 12. Current use of medications that will have an effect on bronchospasm and/or pulmonary function. 13. Current evidence or history of hypersensitivity or idiosyncratic reaction to test medications or components. 14. Receipt of an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid). 15. Current participation in a clinical study. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To compare the efficacy and safety of FlutiForm, measured by Forced Expiratory Volume in the 1st second (FEV1). |
|
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 | Yes |
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 | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 31 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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
|
Last visit of the last subject undergoing the trial (including extension phase) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |