E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Children aged 7 - 12 with stable mild persistent to moderate persistent asthma (according to the GINA classification)
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
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 |
Compare the effectiveness of QvarTM AH therapy with conventional (fixed combination) asthma therapy (similar doses) |
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E.2.2 | Secondary objectives of the trial |
Assess the safety of QvarTM AH Assess direct and indirect costs associated to asthma during intake of QvarTM AH
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Written informed consent signed by child and both parents - Children from 7 (inclusive) to 12 (inclusive) years old - Diagnosed since at least 6 months with mild persistent to moderate persistent asthma (according the GINA Guidelines) - Treated since at least 1 month with Seretide (fluticasonpropionate and salmeterol) 400 mcg max discus haler daily or Symbicort (budenoside and formoterolfumarate) 600 mcg max turbohaler daily - >60% PEFR after withholding bèta-2-agonist therapy for at least 4 hours measured at visit 1 - Willing to comply with daily dairy recording and with visit schedule - Otherwise healthy
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E.4 | Principal exclusion criteria |
- Asthma treatment different from Seretide discus haler daily or Symbicort turbohaler daily - Oral/ rectal/ intravenous corticoid treatment - Hypersensitivity to one of the drugs used during study or for inhaled excipient. - Continuous use of bèta-blockers - Acute respiratory tract infection during the past 2 weeks - Oral candidiasis which is clinically visible
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E.5 End points |
E.5.1 | Primary end point(s) |
• compare the effectiveness of QvarTM AH therapy with conventional fixed combination asthma therapy (similar doses)
• assess the safety of QvarTM AH
• assess direct and indirect costs associated to asthma during intake of QvarTM AH
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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
| No |
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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Trial will end after the last visit of the last subject participating in the trial (total duration of treatment per patient is 12 weeks) |
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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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |