E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
Comparison between: -clinical symptoms and lung function variables (“gold standard” – primary outcome) and -eNO and markers of inflammation in exhaled breath condensate (secondary outcome) During step-down therapy with combined preparations (Symbicort 160/4.5, budesonide /formoterol) in stable and moderately severe asthma from Symbicort 160/4.5 2 * 2 inhalations to 2 * 1 inhalation.
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-Informed consent -Male and female patients between 18 and 65 years -Established diagnosis of asthma at least 3 months before the start of the study and based on: documented reversible airway obstruction of >= 9% of predicted or documented positive metacholine provocation test -Treatment with Symbicort 160/4.5 2*2 during the last 2 months -Clinical stable patients with asthma symptoms < 1 a week, no nocturnal symptoms, PEF variability < 20% -Patients are able to use Symbicort T (and Bricanyl T) correctly -Patients are able to use Peak flow measurements correctly
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E.4 | Principal exclusion criteria |
-Patients with severe cardiovascular disease -Smoking -Recent upper airway infection (within one month before the start of the study) -Chronic rhino-sinusitis -Use of systemic steroids 30 days before the start of the study -Use of ß blocking agents -Pregnancy and breast feeding during the study -Addiction to alcohol or drugs that may interfere with the overall compliance -Planned surgical interventions during the study period -Concomitant treatment with anticholinergics, theophyllines and LTRA -At visit 2: infections and unstable asthma (symptoms more than 1time a week, nocturnal symptoms, PEF variability of >20%) or upper respiratory tract infection during run-in
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E.5 End points |
E.5.1 | Primary end point(s) |
-symptom scores, peak flow variability, dynamic lung volumes (FEV1 and FEV1/FV), extra use of bronchodilators (short acting ß2), nocturnal symptoms and -eNO and inflammatory markers in EBC (cytokines, markers of oxidative stress)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | No |
E.8.1.1 | Randomised | No |
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 | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |