Status:
COMPLETED
Study With High Dose PURETHAL Mites in Allergic Rhinitis/Rhinoconjunctivitis Patients
Lead Sponsor:
HAL Allergy
Conditions:
Allergic Rhinitis
Allergic Rhinoconjunctivitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of the study is to establish the maximum tolerated dose of PURETHAL Mites that is achieved by 90% of the patients with less than 20% of the injections giving rise to a swelling of \> 5 cm and ...
Detailed Description
The tolerability and safety of three different initial treatment regimens PURETHAL mites in patients with allergic rhinitis / rhinoconjunctivitis induced by house dust mites will be evaluated and the ...
Eligibility Criteria
Inclusion
- Patients with perennial rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 \> 70%) for at least 2 years. with allergic symptoms related to HDM
- Positive CPT test to HDM Der p, dose ≤10,000 AUeq/ml
- Positive SPT to HDM Der p or Der f (mean wheal diameter ≥ 3mm)
- Specific serum IgE-test (ssIgE \> 0.7 U/ml) for HDM
- Age ≥ 18 years
- Written informed consent given
Exclusion
- Patients with concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3 mm) to other allergens than HDM should not be included if they have clinical symptoms at the time of inclusion, related to the other allergen
- Patients sensitized to pets should not be included if they live together with these pets or have clinical symptoms
- Immunotherapy (including sublingual) with HDM within the last 5 years
- Immunotherapy (including sublingual) during the study period
- Chronic asthma or emphysema, particularly with a FEV1 ≤ 70% of predicted value or use of inhalation corticosteroids
- Serious immuno-pathologic diseases or malignancies (including auto-immune diseases, tuberculosis)
- Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension
- Diseases with a contra-indication for the use of adrenaline
- Patients who are using other aluminium preparations, e.g. antacids
- Severe kidney disease
- Use of systemic steroids
- Treatment with systemic and local Beta-blockers or immunosuppressive drugs
- Active infection of the target organs (nose or eyes)
- Severe atopic dermatitis in case systemic immunosuppressive medication is used
- Participation in a clinical study with a new investigational drug within the last 3 months
- Pregnancy, lactation or inadequate contraceptive measures (adequate contraceptive measures will be the use of a contraceptive device or -pill)
- Alcohol- or drug abuse
- Lack of co-operation or severe psychological disorders
- Institutionalisation by official or judicial order
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00973453
Start Date
August 1 2009
End Date
August 1 2010
Last Update
September 12 2011
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Allergie-Centrum Charité, Klinik für Dermatologie, Venerologie und Allergologie, Charité Campus Mitte, Universitätsmedizin Berlin
Berlin, Germany, D-10117
2
Hals, Nasen- und Ohrenheilkunde
Berlin, Germany, D-13057
3
Allergy & Asthma Center Westend
Berlin, Germany, D-14050
4
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, D-40225