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 | 9.1 |
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 |
To compare efficacy of Symbicort Maintenace and Reliever Therapy (Symbicort SMART) administered over 6 months at two different maintenance doses in adult asthmatic subjects on IGCS: 1 inhalation Symbicort 160/4.5 ug BD or 2 inhalations Symbicort 160/4.5 ug BD. |
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E.2.2 | Secondary objectives of the trial |
To compare the cost-effectiveness of Symbicort SMART at two different maintenance doses.
To assess the safety of Symbicort SMART at two different maintenance doses.
To investigate whether or not subject characteristics at study entry predict which subjects benefit from a higher maintenance dose. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Visit 1 Provision of informed consent. Adult outpatients with a minimum of 6 months history of persistent asthma. Use of IGCS for at leat one month with the same daily dose of at least 600ug beclamethasone, 400ug budesonide, 200ug fluticasone, 400ug mometasone, 250ug beclomethasone, 250ug beclomethasone ultrafine particles or 320ug ciclesonide. Subjects with a history of use of SABAs for symptom relief during the previous 30 days. Visit 2: Use of at least one as needed inhalation for symptom relief on at least 4 of the last 7 days of the run-in period for subjects treated with IGCS without LABA and on at least 2 of the last 7 days of the run-in period for subjects treated with IGCS and LABA. No severe asthma exacerbation during run-in period. No change in asthma maintenance treatment during run-in period |
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E.4 | Principal exclusion criteria |
Subjects currently treated with Symbicort SMART Known or suspected hypersensitivity to study therapy or excipients of the IMP including lactose Asthma exacerbation within the last 14 days prior to visit 1 Subjects using oral, rectal or parenteral GCS during the last 14 days prior to visit 1. Use of any beta-blocking agents. Use of systemic treatment with potent CYP3A4 inhibitors. Subjects treated with omazilumab, nebublised bronchodilators and/or nebulised glucocorticosteroids. Subjects aged over >40 years with a smoking history of more than 10 pack-years. Preganancy, breast-feeding or planned pregnancy during the study. Suspected poor capability to follow instructions of the study. Participation in a clinical study during last 30 days. Planned hosptialisation during study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to first severe asthma exacerbation defined as deterioration in asthma leading to need for oral/systemic glucocorticosteroids for at least 3 days and/or need for hospitalisation/ermergency room visit because of asthma requiring oral/systemics glucocorticosteroids, or equivalent.
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
1 or 2 inhalations Symbciort Turbuhaler 160/4.5micrograms |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 20 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 1200 |
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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Last visit of last subject undergoing trial. Database lock. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
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 | 7 |