E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The trial will be carried out in children (aged 5 - 12 years at study onset) with rhinoconjunctivitis caused by grass pollen allergy. The aim of the trial is to investigate whether three consecutive years of treatment with Grazax (75.000 SQ-T) reduce the risk of developing asthma compared to placebo. |
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E.1.1.1 | Medical condition in easily understood language |
Asthma is the common chronic inflammatory disease of the airways characterized by variable and recurring symptoms, reversible airflow obstruction, and bronchospasm. |
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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 | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
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 investigate the effect of Grazax compared to placebo on the risk of developing asthma. |
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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 the grass pollen season (GPS).
To investigate the proportion of subjects with and without asthma when comparing Grazax and placebo at end of trial.
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 months, 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) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The evaluation of the primary end point will be performed after the end of the trial. |
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E.5.2 | Secondary end point(s) |
Time to onset of asthma in GPS.
Asthma status (yes/no) (i.e. status of being asthma symptom free since last visit*) at end of trial visit.
Average VAS score of rhinoconjunctivitis symptoms.
*Asthma symptom free since last visit is defined as when a subject is
neither under treatment for asthma nor has experienced asthma
symptoms (any episodes of wheeze, cough, shortness of breath or chest
tightness) since last visit. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The evaluation of the secondary end points will be performed after the end of the trial. |
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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 | 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 | 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
| 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 | 18 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 75 |
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 | No |
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 |
Austria |
Denmark |
Finland |
France |
Germany |
Norway |
Poland |
Spain |
Sweden |
Switzerland |
United Kingdom |
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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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End of trial is when the last subject has completed Visit 15 (last visit). |
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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 |