E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pediatric patients age 6-12 yrs with uncontrolled mild persistent asthma |
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E.1.1.1 | Medical condition in easily understood language |
Pediatric patients age 6-12 yrs with uncontrolled mild persistent asthma |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003555 |
E.1.2 | Term | Asthma bronchial |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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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 evaluate the effect of an additional therapy with Prospan on the lung function parameters MEF75-25 and FEV1 (relative change)
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of an additional therapy with Prospan on 1. MEF75-25 before bronchodilation – absolute change between V2 and V3, and between V4 and V5 respectively 2. FEV1 before bronchodilation – absolute change between V2 and V3, and between V4 and V5 respectively 3. FeNO 4. Exhaled breath condensate pH 5. Peak flow profile 6. Emergency treatment (beta agonist) 7. Number of days with asthma symptoms 8. ACT result 9. ACQ result 10. Tolerance
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Medical diagnosis of uncontrolled, mild, persistent, allergic bronchial asthma in terms of the bronchial asthma NVL Version 1.3 (2011) 2. Children aged from 6 to 12 years (girls and boys) 3. Signed Informed Consent of the patient and legal guardians to participate in the trial after written and verbal briefing by the Investigator 4. Improvement of the FEV1≥12% after 2 puffs of terbutaline 100 µg during steroid monother-apy with 400 µg budesonide equivalent/day or an ACT score ≤ 19 as an indication of insuf-ficient asthma control 5. Asthma diagnosis for at least one year
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E.4 | Principal exclusion criteria |
1. Anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure 2. Participation of the patient in another clinical trial within the last four weeks before enroll-ment in this trial 3. Patients or their legal representatives who are unable to understand the written and/or verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the trial (e.g. lacking compliance) 4. Inability to measure lung function, to test bronchospasmolysis, to determine FeNO or to col-lect exhaled breath condensate, inability to document the symptoms in a symptom log book or questionnaire; inability to take the trial medication properly 5. Chronic illnesses of different aetiology 6. Vocal cord dysfunction 7. Premature birth or diagnosis of bronchopulmonary dysplasia 8. Gastro-oesophageal reflux 9. Acute respiratory infection within the previous 4 weeks 10. Hereditary fructose intolerance 11. Pregnant or breastfeeding women
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E.5 End points |
E.5.1 | Primary end point(s) |
Change of MEF75-25 and FEV1 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
days-28, 0, 28, 56, 84, 112 |
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E.5.2 | Secondary end point(s) |
1. MEF75-25 before bronchodilation – absolute change between V2 and V3, and between V4 and V5 respectively 2. FEV1 before bronchodilation – absolute change between V2 and V3, and between V4 and V5 respectively 3. FeNO 4. Exhaled breath condensate pH 5. Peak flow profile 6. Emergency treatment (beta agonist) 7. Number of days with asthma symptoms 8. ACT result 9. ACQ result 10. Tolerance
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
days-28, 0, 28, 56, 84, 112 |
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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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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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After last patient completed run-out Visit 6 (LPLV) |
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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 | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |