E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild persistent asthma(fulfilling the criteria for asthma of severity grade GINAII) requiring daily maintenance treatment |
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MedDRA Classification |
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 main objective of the study is to compare Seretide Diskus with Flutide Diskus in controlling mild persistent asthma. The protocol allow an increase in treatment during the first six months of the 18 months blinded study as strictly defined in the protocol, i.e. patients not having a good asthma control exactly defined in the protocol increase the treatment successively as needed to stronger formulations of the study medicines. The number of patients in each arm with a need of an increase of study medication is the primary outcome measure. |
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E.2.2 | Secondary objectives of the trial |
Other important aims include study of change in bronchial hyper-responsiveness (by using metacholine challenge test, which has a high sensitivity and is thus useful when studying mild asthma). Asthma exacerbations including severity of exacerbations and time to first exacerbation will be compared. "Normal" outcome variables include number of symptom free days and nights without use of rescue medication, morning and evening peak flow, diurnal peak-flow variation and FEV1 and FVC as well. Further, quality of life and health economics will be studied. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Visit 1: Subject who are willing to give written informed consent to participate in the study. 2. Males and females ages 18-70 years. 3. Subjects who are able to understand and complete a DRC. 4. Mild persistent asthma according to GINAII as described under "patients" and further developed under additional patient criteria (please see protocol). At randomisation: 1. Day symptoms during run-in more than once a week but not every day. 2. Night symptoms not more than once a week. 3. Lungfunction with FEV1≥80% of predicited value before or after a broncho-dilation test. 4. A bronchial variability documented by metacholine reactivity PC20≤8mg/ml according to the Juniper-Hargreave method or other validated comparable methods. |
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E.4 | Principal exclusion criteria |
1. Changes to regular asthma treatment in the four weeks prior to visit1. 2. Taken oral, depot or parenteral corticosteroids for the treatment of asthma or any other disease within eight weeks of visit 1. 3. Lower respiartory tract infection within four weeks of visit 1. 4. Received any investigational drugs within four weeks of visit 1. 5. Smoking history of 10 pack years. 6. Serious uncontrolled disease likely to interfere with the study. 7. Medical conditions or taking medications that are known to affect the assessment or any of the study endpoints. 8. In the opionon of the investigator evidence of alcohol or drug abuse. 9. Known or planned pregnancy. 10. Known or suspected hypersensitivity to inhaled cortico-steroids, ß2-agonist or lactose. 11. Previously been enrolled into this study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcomes measure: Number of patients in each arm with a need of an increase of study medication. Secundary outcomes measures: 1. Bronchial hyper-responsiveness, both change from baseline and in absolute values at the end of the study. 2. Number of symptom free days and nights without use of rescue medication. 3. Number of exacerbations; totally, by degree of severity, and by medicine treated exacerbations. 4. Time to first exacerbation; by degree of severity, and by medicine treated exacerbations. 5 Time to increase of study medication. |
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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) | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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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The trial will end with a visit 18 months after randomisation. (Analyses will be performed both according to the intension to treat model and per protocol) |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |