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 |
The primary objective of this study is to compare the efficacy of Symbicort Maintenance And Reliever Therapy administered over 6 months at two different maintenance doses in adult asthmatic subjects on inhaled glucocorticosteroids with an indication for long-acting b2 agonist:- 1 inhalation of Symbicort 160µg/4.5µg bid - 2 inhalations of Symbicort 160µg /4.5µg bid. The efficacy of Symbicort SMART treatment using the two different maintenance doses will be compared in the total group and within two strata defined on the basis of the dose of inhaled glucocorticosteroids taken at inclusion: low-medium dose (minor-egual 1000µg beclomethasone, minor-egual; 800µg budesonide(metered dose),minor-egual 500µg fluticasone, minor-egual 800µg mometasone, minor-egual 500µg beclomethasone ultrafine particles, or minor-egual 320µg ciclesonide)and high dose(> 1000µg beclomethasone,>800µg budesonide (metered dose),>500µg fluticasone,> 800µg mometasone,>500µg beclometasone ultrafine |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are:-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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
For inclusion in the study run-in period subjects must fulfil all of the following criteria at visit 1: 1. Provision of informed consent. The signed and dated informed consent must have been obtained before conducting any study-related procedures, including withdrawal of concomitant medication. 2. Outpatients, of either sex, >= 18 years with a minimum of 6 months documented history of persistent asthma according to the American Thoracic Society definition (ATS 1987). 3. Use of IGCS for at least one month with the same daily dose of at least 500µg beclomethasone, 400µg budesonide (metered dose), 200µg fluticasone, 400µg mometasone, 250µg beclomethasone ultrafine particles or 320µg ciclesonide. 4. Subjects with history of use of rapid - acting ß2 agonists for symptom relief during the last 30 days (SABA or formoterol). To be randomised to the treatment period, the following criteria must be fulfilled at visit 2: 5. 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 both IGCS and LABA. 6. No change in asthma maintenance treatment during the run-in period. 7. No severe asthma exacerbation during the run-in period. |
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E.4 | Principal exclusion criteria |
Any of the following is regarded as a criterion for exclusion from the study: 1. Subjects currently treated with Symbicort SMART. 2. Known or suspected hypersensitivity to study therapy or excipients of the investigational product including lactose. 3. Asthma exacerbation within the last 14 days prior to or at visit 1. 4. Subjects using oral, rectal or parenteral GCS during the last 14 days prior to visit 1. 5. Use of any â-blocking agent, including eye-drops. 6. Use of systemic treatment with potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, ritonavir). 7. Subjects treated with omazilumab, nebulised bronchodilators and/or nebulised glucocorticosteroids. 8. Subject aged > 40 years with a smoking history of + 10 pack-years. 9. Subjects with COPD or other significant respiratory disease as judged by the investigator. 10. Pregnancy, breast-feeding or planned pregnancy during the study. Women of child bearing potential not using acceptable contraceptive measures, as judged by the investigator. 11. Any significant disease or disorder or clinically significant abnormal finding, which, in the opinion of the investigator, may put the subject at risk because of participating in the study, or influence the results of the study or the subject's ability to participate in the study. 12. Suspected poor capability to follow instructions of the study, e.g. because of a history of drug abuse, difficulty in reading and/or understand instructions or any other reason, as judged by the investigator. 13. Previous allocation of randomisation code in the present study. 14. Participation in a clinical study during the last 30 days. 15. Planned hospitalisation during the study. 16. Involvement in the planning or conduct of the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy of Symbicort Maintenance And Reliever Therapy (SMART) |
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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 | Yes |
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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
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 |
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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 | Yes |
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 | 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 | 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 |