E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The aim of the trial is to investigate whether three consecutive years of treatment with Grazax (75.000 SQ-T) reduces the risk of developing asthma in children compared to placebo. |
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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 |
To investigate the effect of Grazax compared to placebo on the risk of developing asthma during three treatment years and three treatment years plus two post-treatment years |
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E.2.2 | Secondary objectives of the trial |
To investigate the effect of Grazax compared to placebo on the risk of developing asthma during grass pollen season (GPS) after three treatment years and three treatment years plus to post-treatment years.
To investigate the proportion of subjects with and without asthma when comparing Grazax and placebo after three treatment years and three treatment years plus two post-treatment years.
To investigate the efficacy of Grazax compared to placebo based on visual analogue scale (VAS) scoring of rhinoconjunctivitis symptoms in the GPS |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Females and males 5-12 years of age at time of randomisation Written informed consent obtained from parents/guardians Assent from subject, according to national guidelines A clinical relevant history of grass pollen induced allergic rhino-conjuctivitis having received symptomatic treatment during the GPS 2009 and 2010, Positive Skin Prick Test (SPT) reponse (wheal diameter ≥ 3 mm) to Phleum pratense Positive specific IgE against Phleum Pratense (≥ IgE Class 2) Female subjects, who are fertile must have a negative pregnancy test |
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E.4 | Principal exclusion criteria |
A clinical relevant history of symptomatic seasonal allergic rhinitis and/or conjunctivitis caused by an allergen other than grass overlapping the GPS. A clinical relevant history of symptomatic perennial allergic rhinitis and/or conjuctivitis caused by an allergen, to which the subject is regularly exposed. Not capable of perfoming reproducible lung function tests A medical history of astma and/or wheezing within the last two years. A medical hsiotry of asthma and/or wheezing since the 5th birthday. Use of asthma medication within the last 12 month, to treat respiratory and/or pulmonary symptoms which resulted in a clinical relevant effect. An increase in FEV-1 of ≥ 12% after administration of a beta-2-agonist Investigator diagnosed asthma Diurnal PEF variability > 20% for at least 3 out of 14 consecutive days
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E.5 End points |
E.5.1 | Primary end point(s) |
Time of onset of asthma during three treatment years Time of onset of asthma during five years (three treatment years plus two post-treatment years)
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 85 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |