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 | 10001723 |
E.1.2 | Term | 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 |
To assess the efficacy of transient Trichuris suis infestation of the gut on self-reported symptoms of allergic rhinitis and number of well-days among adults with allergic rhinitis. |
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy and safety of transient Trichuris suis infestation of the gut on allergic rhinitis and asthma assessed through self-reported disease activity, clinical skin and airway activity, and immunological activity among adults with allergic rhinitis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female, aged >18 and <65 years 2. Symptoms of birch and/or grass pollen allergy the last 2 pollen seasons, or more. 3. Forced Expiratory Volume 1 >70% of expected. 4. Scoring all symptoms of allergic rhinitis >50 mm on a 100 mm VAS (0=not bothersome, 10=worst) 5. Specific IgE class >2 to birch and/or grass (>0.7 kUallergen/l) 6. A positive skin prick test (>3mm) to birch and/or grass 7. Women must not be pregnant, and women in fertile age must have a negative pregnancy test, not be breastfeeding, and use birth control during the trial unless sterile or post meno-pausal 8. Prepared to grant authorized persons access to medical records 9. The volunteer is likely to comply with instructions
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E.4 | Principal exclusion criteria |
1. Significant asthma 2. Use of systemic steroids during the last 2 months 3. Immune therapy for birch or grass pollen allergy the last 2 years, or more. 4. Planning a travel abroad during the trial period (excluding areas with a similar grass/birch pollen counts when compared with the Copenhagen area) 5. Past or current severe diseases (a history of active hepatitis B or C, cytomegalovirus, herpes simplex, HIV, other kinds of immune deficiency, and cancer) 6. Anti-helminth treatment within the last 2 weeks (e.g mebendazol) 7. Known or possible hypersensitivity to Trichuris species or compounds made of Trichuris species 8. A past or recent drug abuse 9. Participation in other clinical trials 10. Employed with the Investigator (Pulmonology- and Allergy Clinic Copenhagen (center of trial)), or the relevant department at the sponsor institution (Department of Epidemiology Research at Statens Serum Institut).
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E.5 End points |
E.5.1 | Primary end point(s) |
Daily score for symptoms of allergic rhinitis, and number of well days during the pollen season. |
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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 | 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 | 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) | 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 | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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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The definition of end of trial is when the final trial close-out monitoring report has been submitted and approved by the Sponsor. The report should document that all activities required for trial close-out are completed, and copies of essential documents are held in the appropriate files.
Participants will be followed up 6 weeks after the 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 | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |