A randomised controlled multicentre study for the safety of Depigoid(R)rush schedule

• Conditions: Rhinitis and/or rhinoconjunctivitis without uncontrolled asthma caused by clinical relevant sensitisation againts tree pollen, grass pollen or house dust mites; MedDRA version: 8.0Level: LLTClassification code 10001723

• Registration Number: EUCTR2005-001584-66-DE
• Lead Sponsor: ETI Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

1. Patients of both gender aged from 18 up to 65 years
2. Prior to study specific examinations the patient has to give his/her written in-formed consent.
3. FEV1 or PEF > 70% of predicted normal value under normal conditions
4. FEV1 or PEF > 80% of predicted normal value directly before injection
5. The patients have to suffer from allergic complaints (rhinitis and/or rhinoconjunctivitis without uncontrolled allergic asthma) caused by clinical sensitisation against tree pollen, grass pollen or house dust mites. Polysensitised patients can also be included. The IgE mediated sensitisation has to be verified by
· suggestive medical history
· a positive skin prick test LETI for tree pollen, grass pollen or house dust mites, resulting in a wheal diameter of at least 3 mm > negative control re-action or '++' versus histamine
· specific IgE > 1 (CAP-RAST)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnant or lactating women
2. Women of child-bearing age not employing sufficient contraceptive protection (contraceptive medication or condom)
3. Participation in another clinical trial within the last 3 months prior to this study
4. Smokers with a manifested bronchopathy
5. Alcohol- or drug abusers
6. Persons, who are obviously not compliant
7. Patients, who are employees at the investigational site, relative or spouse of the investigator
8. Acute and chronic inflammatory or infectious diseases (incl. target organ)
9. Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis)
10. Immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
11. Immune deficiencies
12. Chronic asthma
13. Treatment with b-blockers
14. Malignancies < 5 years
15. Any disease which prohibits the use of adrenaline (e. g. hyperthyroidism)
16. Serious psychiatric/psychological disturbances
17. Concomitant treatment with substances interfering with the immune system

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparison of the safety of Depigoid(R) rush regimen versus conventional regimen during build-up phase as subcutaneous immunotherapy in patients with rhinitis and/or rhinoconjunctivitis without uncontrolled allergic asthma caused by clinical relevant sensitisation against tree pollen, grass pollen or house dust mites.<br>The primary criterion is the proportion of patients reaching the maintenance treatment phase.;Secondary Objective: Systemic reactions according DGAI <br>Severity of systemic reactions assessed on a VAS within the respective DGAI category<br>Proportion of patients with systemic reactions <br>Proportion of patients with local reactions <br>Physician’s overall assessment of the treatment <br>Patient’s overall assessment of the treatment<br>Other adverse events <br>Laboratory parameters <br>Vital signs;Primary end point(s): Proportion of patients reaching the maintenance treatment phase.