E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
First wheezing episode (=acute expiratory breathing difficulty) associated with rhinovirus infection in 3 to 23 -month-old children. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047925 |
E.1.2 | Term | Wheezing expiratory |
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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 |
Main Hypothesis and Anticipated Results Therapeutic intervention with systemic corticosteroid: Systemic corticosteroid in children susceptible for rhinovirus-induced early wheezing 6. decreases the severity and relapses of the first wheezing episode, 7. decreases persistence of rhinovirus infection and prevents recurrent wheezing, and asthma, 8. prevents Th2-polarization, favours Th1- and Treg-responses during the treatment period.
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E.2.2 | Secondary objectives of the trial |
Main Hypothesis and Anticipated Results Virology: 1. Rhinovirus is a common causative agent of bronchiolitis. 2. Persistence of rhinovirus infections worsens long-term outcome. 3. The dose of virus inoculation at the time of acute wheezing (assessed semi-quantitatively for rhinovirus and respiratory syncytial virus) is related to outcome. Immunology: 4. Children susceptible to rhinovirus induced early wheezing have altered immunology (T cell regulation and interferon responses) when compared to RSV induced wheezers and children with rhinovirus induced upper respiratory infection without wheezing. 5. These immunological events are related to recurrent wheezing and asthma inception.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
General Inclusion Criteria Age 3-24 months, be delivered at >37 weeks, first wheezing episode OR upper respiratory tract infection without wheezing, written informed consent from guardian.
Inclusion Criteria for the Intervention Rhinovirus PCR positive wheezing episode and still signs of lower respiratory symptoms (cough, noisy breathing or wheezing) at the time the initiation of study drug.
Inclusion Criteria for the Follow-up First wheezing episode induced by rhinovirus or RSV OR rhinovirus induced upper respiratory tract infection without wheezing, written informed consent from guardian.
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E.4 | Principal exclusion criteria |
Chronic illness other than atopy, previous systemic or inhaled corticosteroid treatment, participation to another study (excluding long-term follow-up studies in childhood), varicella contact if previously intact, or poor understanding of Finnish.
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E.5 End points |
E.5.1 | Primary end point(s) |
The occurrence of and time to a new physician-confirmed wheezing episode within 2 months after discharge; number of physician-confirmed wheezing episodes during the first 12 months after discharge; diagnoses of asthma during the full study period. Asthma is defined as >4 episodes of wheezing (at least 2 weeks apart) in the past year that lasted more than one day and affected sleep and who have risk factors for the development of asthma (parental history of asthma or physician-diagnosed atopic dermatitis or two of the following: physician diagnosed allergic rhinitis, wheezing apart from colds or peripheral blood eosinophilia >0.3 x 109/l). |
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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 | No |
E.6.4 | Safety | No |
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) | 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 | 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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Respiratory syncytial virus wheezing group; Rhinovirus non-wheezing group |
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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 | 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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Criteria for the termination of the study are: 1. Parent or guardian neglect the study orders. 2. Parent or guardian does not want to continue the study with any reason. 3. Completion of the study (i.e. full 6-year follow-up).
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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 | 9 |
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 | 9 |