E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Seasonal grass pollen induced allergic rhino-conjunctivitis with or without asthma. |
Seasonal grass pollen induced allergic rhino-conjunctivitis. |
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E.1.1.1 | Medical condition in easily understood language |
Allergy due to grass pollen. |
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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 | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001728 |
E.1.2 | Term | Allergic rhinoconjunctivitis |
E.1.2 | System Organ Class | 100000004853 |
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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 efficacy of AVANZ® Phleum pratense 15000 SQ+ compared to placebo in the treatment of grass pollen-induced allergic rhinitis using a Environmental Challenge Chamber.
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E.2.2 | Secondary objectives of the trial |
To evaluate;
The safety and tolerability of AVANZ® Phleum pratense 15000 SQ+ compared to placebo.
Changes in immunological parameters.
The efficacy of AVANZ® Phleum pratense 15000 SQ+ during treatment.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A documented clinically relevant history of moderate-to-severe grass pollen induced rhinoconjunctivitis with or without asthma despite having received treatment with symptom relieving medication during the previous two grass pollen seasons
Positive SPT response (wheal diameter ≥ 3 mm) to Phleum pratense at screening
Positive specific IgE against Phleum pratense (≥ IgE Class 2; ≥0.70 kU/L) at screening
Minimum level of rhinitis symptoms in an grass pollen challenge, defined as a TNSS of at least 6 (of 12) within the 3-hour grass pollen challenge at performed at the baseline ECC visit
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E.4 | Principal exclusion criteria |
Rhinoconjunctivitis caused by ragweed, mugwort or Alternaria alternate, . Subjects sentised to ragweed, mugwort or Alternaria alternate are not eligible for the trial if they have symptoms induced by these allergens
Rhinoconjunctivitis caused by animal hair and dander to which the subject is regularly exposed. Subjects sensitised to perennial allergens such as house dust mites, and moulds are not eligible for the trial if they have symptoms induced by these allergens
Clinical history of uncontrolled asthma within 3 months prior to screening
Subjects with reduced lung function FEV1 <70% of the predicted value after adequate pharmacologic treatment
Subjects with asthma requiring treatment with inhaled corticosteroids outside the grass pollen seasons
Previous treatment with immunotherapy to a grass pollen allergen or a cross-reacting allergen within the past 5 years
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the average Total Nasal Symptom Score (TNSS) measured after end of treatment with AVANZ compared to placebo.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After approximately 11 months of treatment with AVANZ |
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E.5.2 | Secondary end point(s) |
Changes in immunological parameters during and after treatment with AVANZ.
Adverse Events during treatment with AVANZ.
Average Total Nasal Symptom Score (TNSS) measured during treatment with AVANZ compared to placebo.
Average Total Nasal and Eye Symptom Score measured during and after treatment with AVANZ compared to placebo.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During and after treatment with AVANZ. |
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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 | Yes |
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 | 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 | 17 |
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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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 | 5 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |