E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | LLT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
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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 primary objective of this study is to evaluate the safety of fluticasone propionate/salmeterol 100/50mcg HFA twice daily compared with fluticasone propionate 100mcg HFA twice daily in subjects 4-11 years of age with persistent asthma |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Type of Subject: A subject must be treatable on an outpatient basis. Age: A subject must be 4-11 years of age at Visit 1. Gender: Male or pre-menarchal female Disease: Each subject must have a diagnosis of asthma which has required physician-prescribed pharmacotherapy for at least two months prior to Visit 1 Severity of Disease: At Visit 1, after withholding asthma medications, subjects 6-11 years of age must demonstrate a baseline best morning pre-albuterol (salbutamol) clinic FEV1 greater than or equal to 60% of the Polgar predicted value and subjects 4 and 5 years of age must demonstrate a best morning pre-albuterol (salbutamol) clinic AM PEF greater than or equal to 60% of the Polgar predicted value Reversibility Component: A subject must have historical documentation of an increase in FEV1 or PEF of greater than or equal to 12% within 30 minutes following administration of albuterol (salbutamol) (MDI or nebulized) or levalbuterol within 24 months prior to Visit 1, or current reversible airways disease as demonstrated at Visit 1 by an increase in FEV1 of than or equal to 12% over the pre-albuterol (salbutamol) inhalation aerosol FEV1 (6-11 years) or PEF (4 and 5 years) within 30 minutes after the inhalation of 2-4 puffs (180-360mcg) or one nebulized treatment of albuterol (salbutamol) Concurrent Anti-Asthma Therapy: Subjects are eligible to participate in the trial if they have been using an inhaled corticosteroid at a consistent dose, within the range specified in the protocol, for at least one month prior to Visit 1 |
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E.4 | Principal exclusion criteria |
Life Threatening Asthma: A subject must not have life-threatening asthma. Life threatening asthma is defined for this protocol as a history of significant asthma episode(s) requiring intubation, associated with hypercapnia, respiratory arrest or hypoxic seizures, or asthma-related syncopal episode(s). A subject must not have been hospitalized two or more times in the last year due to asthma Asthma Medications: Certain Asthma medications as listed in protocol must not have been used prior to Visit 1 for the required interval indicated in the protocol, and not taken during the study. Corticosteroid Therapy: The use of any corticosteroid medication other than study medication, intranasal corticosteroids, and low potency (of greater than or equal to 1%) topical hydrocortisone cream or ointment during the study is prohibited |
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E.5 End points |
E.5.1 | Primary end point(s) |
The safety measures for this study include adverse events, 12-lead electrocardiograms (ECGs), laboratory tests (hematology/chemistry), 24-hour urinary cortisol excretion, blood pressure, oropharyngeal examination findings, asthma exacerbations, and percent of subjects withdrawn due to worsening asthma. |
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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 | Information not present in EudraCT |
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) | 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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
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 |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 | 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
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Telephone call 5+ 2 days following Visit 7/Discontinuation Visit to assess post-treatment adverse events |
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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 | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |