E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Grass pollen induced allergic rhinoconjunctivitis with or without asthma. |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001728 |
E.1.2 | Term | Allergic rhinoconjunctivitis |
E.1.2 | System Organ Class | 10015919 - Eye 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 evaluate the efficacy of two dosing schedules of Avanz Phleum pratense compared to placebo in subjects suffering from grass pollen induced allergic rhinoconjunctivitis with or without asthma. The evaluation is based on the combined rhinoconjunctivitis daily symptoms score (DSS) and rhinoconjunctivitis daily medication score (DMS) during the entire grass pollen season (GPS). |
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E.2.2 | Secondary objectives of the trial |
- To compare efficacy between the two dosing schedules of Avanz Phleum pratense and placebo with respect to the average rhinoconjunctivitis DSS and DMS for the entire GPS
- To assess overall safety
- To compare the two dosing schedules of Avanz Phleum pratense and placebo with respect to:
Immunological parameters
Pharmacoeconomic parameters
Quality of life (QOL)
Asthma symptoms and medication in the grass pollen season. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adults with documented clinically relevant history of grass pollen induced allergic rhinoconjunctivitis with or without asthma despite having received symptomatic treatment during the grass pollen seasons 2010 and 2011
- A clinical history of severe rhinoconjunctivitis interfering with usual activities or sleep, and subjects who experience an appropriate minimum level of symptoms (defined as a rhinoconjunctivitis DSS score of >/= 10 on the worst day of the previous GPS season) prior to randomisation can be enrolled.
- Positive SPT response to Phleum Pratense
- Positive specific IgE against Phleum pratense. |
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E.4 | Principal exclusion criteria |
- A clinically relevant history of symptomatic seasonal allergic rhinoconjunctivitis caused by an allergen, other than grass, overlapping the grass pollen season.
- Asthma with reduced lung function defined as FEV-1 <70% of predicted value after adequate pharmacologic treatment.
- Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomisation. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- The combined (sum of) rhinoconjunctivitis DSS and DMS averaged over the entire GPS
- The combined score for each subject is calculated as the sum of rhinoconjunctivitis DSS and DMS during the entire GPS divided by the number of days with diary records in the entire GPS (=Σ(DSS+DMS)/(Records in GPS)).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- The average rhinoconjunctivitis DSS for the entire GPS, calculated for each subject as the sum of the rhinoconjunctivitis DSS during the entire GPS devided by the number of days with diary records in the entire GPS.
- The average rhinoconjunctivitis DMS for the entire GPS, calculated for each subject as the sum of the rhinoconjunctivitis DMS during the entire GPS divided by the number of days with diary records in the entire GPS. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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) | 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 | 3 |
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 | 37 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 52 |
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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Database closure when all data queries are resolved. |
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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 | 3 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |