Investigation of a preseasonal rush treatment scheme with Depigoid® Grass Mix as an add-on therapy in patients with allergic rhinitis and/or rhinoconjunctivitis sensitized to grass polle

• Conditions: Intermittent rhinitis and/or rhinoconjunctivitis with or without asthma bronchial caused by clinical relevant sensitisation against grass pollen.; MedDRA version: 8.1Level: LLTClassification code 10039083Term: Rhinitis

• Registration Number: EUCTR2006-003065-14-DE
• Lead Sponsor: ETI Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Prior to study specific examinations the patient has to give his/her written informed consent
2.Patients (= 12 years old) with a history of moderate to severe intermittent rhinitis and/or rhinoconjunctivitis during the grass season according to ARIA classification (28)
3.Symptoms more than 2 years prior to study start
4.Detectable specific IgE = 2 CAP RAST to grass pollen at the screening visit (V1) or within the previous 12 months
5.Positive skin-prick test (wheal diameter of at least 3 mm > negative control; Phleum pollen, 30 HEPL/ml; Laboratorios LETI, S.L, Tres Cantos, Spain)

Are the trial subjects under 18? yes
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Disease specific criteria
1.History of significant clinical manifestations of allergy as a result of sensitiza-tion against tree pollen allergens, weed allergens and perennial allergens (e.g. Aspergillus spores, animal dander, house dust mite)
For clarification:
According to the decision tree (see Appendix 3) patients with typical symptoms against the co-allergens birch, house dust mite, cat and dog are not allowed to en-ter the trial. Patients without symptoms will enter the trial if they are not exposed to the allergen even if CAP RAST is = 2. In case they are exposed to the allergen they must have a specific CAP RAST < 2 to be able to enter the trial.

2.Persistent asthma (GINA = II) according to ARIA classification (29)
3.Uncontrolled asthma, defined as FEV1 or PEF = 70% of predicted normal value

Patients with other known concomitant diseases / treatments
4.Active tuberculosis
5.Acute and chronic inflammatory or infectious diseases at the target organ effective
6.Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis)
7.Autoimmune disorders (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases)
8.Immune deficiencies
9.Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism)
10.Cardiovascular insufficiency or any severe or unstable pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant
11.History of malignancy of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
12.Abnormal laboratory parameters and vital signs that could increase the risk to the study participant
13.Alcohol, drug or medication abuse within the past year
14.Severe psychiatric / psychological / neurologic disorders

Patients with other known previous / concomitant treatments
The following therapy is not allowed within the specified period prior to screening as well as during the study and will prevent the patient from being included into the study:

15.SIT against grass pollen within the last 5 years
16.7 days prior and 14 days post an immunization with vaccines
17.Anti-allergic treatment within the last 4 weeks prior to screening
18.b-blocker are not allowed during the entire study and will lead to the patient being withdrawn
19.Treatment with substances interfering with the immune system are not allowed during the entire study and will lead to the patient being withdrawn
20.Use of other investigational drugs at the time of enrolment or within 30 days
21.Treatment with systemic corticosteroids within 3 months prior to the study

Others
22.Patients who are expected to be non-compliant and/or not co-operative
23.Participation in any other clinical study within the last 30 days prior to the start of the study
24.Patients who have already participated in this study
25.Patients who are employees at the investigational site, relatives or spouses of the investigator
26.Any donation of germ cells, blood, organs, or bone marrow during the course of the study
27.Patients who are not contractually capable

Special restrictions for female patients
28.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation
29.Women of child

Study & Design

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