E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 10034382 |
E.1.2 | Term | Perennial allergic rhinitis |
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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 | 10039776 |
E.1.2 | Term | Seasonal allergic rhinitis |
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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 |
Cost-effectiveness: Is subcutaneous immunotherapy (SCIT) with tree pollen (TP), grass pollen (GP) or house dust mites (HDM) or combinations cost-effective compared to usual care (UC) only?
Clinical effectiveness: Is SCIT with more than one allergen clinically more effective - with respect to symptom improvement, medication reduction and health related quality of life - than UC?
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E.2.2 | Secondary objectives of the trial |
What is the adherence to SCIT using retrospective data from the project group, trial based data and data obtained from the PHARMO database? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
* 18-45 years * Clinically relevant moderate to severe allergic rhinitis due to a sensitization for one, two or three of the following allergens: tree pollen (TP), grass pollen (GP) and/or house dust mite (HDM). For each allergen (TP, GP, HDM) the following 3 criteria are evaluated. A sensitization for an allergen is considered clinically relevant and the rhinitis moderate-severe if: 1) specific IgE ≥0.7 kU/l (Phadia) 2) retrospective total symptom score ≥4: participants will score 4 nose symptoms (sneezing, itching nose, watery running nose, nasal blockage) during the previous peak exposure period (TP April 1-May 15; GP May 15-June 30; HDM September 1-October 31) on a 0-3 scale (0=none, 1=mild, 2=moderate, 3=severe; maximum total score=12). 3) the presence of ≥1 of the following complaints due to rhinitis during the previous season: sleep disturbance; impairment of daily activities; leisure and/or sport; impairment of school or work; troublesome symptoms. * Signed informed consent |
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E.4 | Principal exclusion criteria |
* Severe/instable asthma: - FEV1 ≤70% - Asthma exacerbation requiring prednisolon treatment, visit to a first aid station and/or hospitalisation in the preceding 12 months. * Specific IgE ≥ 0.7 kU/l to animals the patient is in daily contact with * Immunotherapy in preceding 5 years * Anatomical disorders of the nose * Language barrier * No daily access to internet (because of web based questionnaires) * Contraindications to immunotherapy (according to international guidelines; i.e. history of anaphylaxis; immunosuppressive treatment etc) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Cost-effectiveness: * The costs per successfully treated patient, where success is based on a global assessment of efficacy by the patient after the allergen peak period in year 2 for the group that starts in 2009 and year one for the group that starts in 2010. * The global assessment of efficacy is based on a rating of general improvement on a 6-point ordinal scale (much worse, a little worse, no change, a little better, much better, completely recovered). The response options “much better” and “completely recovered” define treatment success.
Clinical effectiveness: * The mean daily total rhinitis symptom score in the first year for multi-sensitized patients. * Daily symptom scores will be recorded during the peak exposure periods: tree pollen April 1 - May 15; grass pollen May 15 - June 30; house dust mite September 1 - October 30 (if the patient is treated with two or three allergens, symptom scores will be recorded during two or three periods) * The intensity of 4 rhinitis symptoms (sneezing, itching nose, watery runny nose, nasal blockage) will be subjectively assessed by the patient on a scale grading from 0 = no complaints to 3 = serious complaints.
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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 | 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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
the control group receives ‘usual care’, consisting of anti-allergic medication, e.g. antihistamines |
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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 | 14 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |