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 | 7.0 |
E.1.2 | Classification code | 10003553 |
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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 is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adolescent and adult patients with persistent asthma. The primary outcome variable is: time to first severe asthma exacerbation.
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E.2.2 | Secondary objectives of the trial |
A secondary objective is to collect safety data for treatment in the two treatment groups in adolescent and adult patients with persistent asthma, by evaluating the incidence and types of serious adverse events and discontinuations due to adverse events |
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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 patients must fulfil all of the following criteria at Visit 1:
1.Provision of written informed consent. This must have been obtained before conducting any study related procedures. For underage patients, informed consent from both patient and the patient’s parent/legal guardian must be obtained. Female or male outpatients aged ³12 years.
2.Minimum of 3 months documented history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (Error! Reference source not found.).
3.Prescribed inhaled GCS at a dose of ³320 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
4.Either - daily maintenance treatment with both inhaled GCS and long-acting b2-agonist (LABA) or - daily treatment with inhaled GCS alone (i.e. without LABA) and a history of sub optimal asthma control the month prior to enrolment as judged by the investigator and use of ³3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment.
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E.4 | Principal exclusion criteria |
Any of the following is regarded as a criterion for exclusion from the study: 1.Previous treatment with Symbicort Single inhaler Therapy (use of Symbicort Turbohaler for both maintenance treatment and as needed in response to symptoms as described in Section Error! Reference source not found.).
2.Use of any b-blocking agent, including eye-drops.
3.Use of oral GCS as maintenance treatment.
4.Known or suspected hypersensitivity to study therapy or excipients.
5.A history of smoking ³ 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).
6.Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator.
7.Any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study.
8.Any non-asthma related, clinically significant abnormal finding in physical examination and/or vital signs at Visit 1, which in the opinion of the investigator, may put the patient at risk because of his/her participation in the study.
9.Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at visit 1
10.Planned in-patient hospitalisation during the course of the study.
11.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.
12.Previous allocation of randomisation code in this study.
13.Participating in another clinical trial during the course of this study or within 30 days prior to Visit 1.
14.Involvement in the planning or conduct of this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome variable is: time to first severe asthma exacerbation. |
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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 | 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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
conventional best practice according to GINA - guidelines for the treatment of asthma |
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E.8.3 |
The trial involves single site in the Member State concerned
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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 | 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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End of study is defined as database lock, which is the time point after which no subject will be exposed to study related activities. |
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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 | 10 |
E.8.9.1 | In the Member State concerned days | |