Study With High Dose PURETHAL Mites in Allergic Rhinitis/Rhinoconjunctivitis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HAL Allergy
ClinicalTrials.gov Identifier:
NCT00973453
First received: September 7, 2009
Last updated: September 9, 2011
Last verified: September 2011
  Purpose

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 the optimal regimen to reach this maximum dose will be determined.


Condition Intervention Phase
Allergic Rhinitis
Allergic Rhinoconjunctivitis
Drug: PURETHAL Mites 20,000 AUeq/ml
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Dose Tolerability Study With High Dose PURETHAL Mites in Allergic Rhinitis / Rhinoconjunctivitis Patients

Resource links provided by NLM:


Further study details as provided by HAL Allergy:

Primary Outcome Measures:
  • Early Local Reactions (ELR) occurring 15 minutes after injection. Less than 20% of the injections should give rise to swelling at the injection site of > 5 cm in diameter occurring 15 minutes after injection. [ Time Frame: 17, 14 or 11 weeks per patient for the respective groups ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Late Local Reactions (LLR) occurring within 24 hours after injection, and systemic reactions (SR). General adverse events will be recorded during complete study period. [ Time Frame: 17, 14 or 11 weeks per patient for the respective groups ] [ Designated as safety issue: Yes ]
  • Clinical index score (CIS) during the study compared to baseline score (before treatment). [ Time Frame: weekly during per patient treatment periods of 17, 14 or 11 weeks for the respective groups ] [ Designated as safety issue: No ]
  • Conjunctival provocation test one week after reaching 10,000 AUeq, 20,000 AUeq, or 40,000 AUeq for the respective groups compared to baseline. [ Time Frame: after 7 weeks of treatment ] [ Designated as safety issue: No ]
  • Conjunctival provocation test 2 weeks after the patients have received two maintenance dosages compared to baseline score. [ Time Frame: 17, 14 or 11 weeks for the respective treatment groups ] [ Designated as safety issue: No ]
  • Specific IgE and IgG measured 2 weeks after the patients have received two maintenance dosages compared to baseline score. [ Time Frame: 17, 14 or 11 weeks for the respective treatment groups ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: August 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Slow regimen Drug: PURETHAL Mites 20,000 AUeq/ml

Group 1: slow regimen (12+2 injections) Initial treatment: incremental weekly dose of 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.8, 1.0, 1.2*, 1.6* and 2.0* ml Additional maintenance: 2 two-weekly injections 2.0* ml

*Injection volumes larger than 1 ml will be given as 2 separate injections of equal volume within an area of 1 cm.

Other Name: Immunotherapy for house dust mites allergy
Intermediate regimen Drug: PURETHAL Mites 20,000 AUeq/ml

Group 2: intermediate regimen (9+2 injections) Initial treatment: incremental weekly dose of 0.1, 0.2, 0.4, 0.6, 0.8, 1.0, 1.2*, 1.6* and 2.0* ml.

Additional maintenance: 2 two-weekly injections 2.0* ml

*Injection volumes larger than 1 ml will be given as 2 separate injections of equal volume within an area of 1 cm.

Other Name: Immunotherapy for house dust mites allergy
Fast regimen Drug: PURETHAL Mites 20,000 AUeq/ml

Group 3: fast initial treatment (6+2 injections) Initial treatment: incremental weekly dose of 0.2, 0.4, 0.8, 1.2*, 1.6* and 2.0*ml.

Additional maintenance: 2 two-weekly injections 2.0* ml

*Injection volumes larger than 1 ml will be given as 2 separate injections of equal volume within an area of 1 cm.

Other Name: Immunotherapy for house dust mites allergy

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 optimal regimen to reach the maximum tolerated dose will be determined. The maximum intended dose is a 4-fold dosage compared to the currently used maintenance dose of PURETHAL Mites. The tolerability and safety of the injections will be examined by means of determining the early and late local and systemic reactions. In addition, short-term efficacy of this high dose PURETHAL mites will be determined by means of the Clinical index score (CIS) and two surrogate efficacy markers; the conjunctival provocation test (CPT) and serum levels of allergen specific immunoglobulins (IgG and IgE). These efficacy parameters are purely indicative and not decisive for the further clinical development of PURETHAL Mites.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with perennial rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 > 70%) for at least 2 years. with allergic symptoms related to HDM
  2. Positive CPT test to HDM Der p, dose ≤10,000 AUeq/ml
  3. Positive SPT to HDM Der p or Der f (mean wheal diameter ≥ 3mm)
  4. Specific serum IgE-test (ssIgE > 0.7 U/ml) for HDM
  5. Age ≥ 18 years
  6. Written informed consent given

Exclusion Criteria:

  1. 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
  2. Patients sensitized to pets should not be included if they live together with these pets or have clinical symptoms
  3. Immunotherapy (including sublingual) with HDM within the last 5 years
  4. Immunotherapy (including sublingual) during the study period
  5. Chronic asthma or emphysema, particularly with a FEV1 ≤ 70% of predicted value or use of inhalation corticosteroids
  6. Serious immuno-pathologic diseases or malignancies (including auto-immune diseases, tuberculosis)
  7. Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension
  8. Diseases with a contra-indication for the use of adrenaline
  9. Patients who are using other aluminium preparations, e.g. antacids
  10. Severe kidney disease
  11. Use of systemic steroids
  12. Treatment with systemic and local Beta-blockers or immunosuppressive drugs
  13. Active infection of the target organs (nose or eyes)
  14. Severe atopic dermatitis in case systemic immunosuppressive medication is used
  15. Participation in a clinical study with a new investigational drug within the last 3 months
  16. Pregnancy, lactation or inadequate contraceptive measures (adequate contraceptive measures will be the use of a contraceptive device or -pill)
  17. Alcohol- or drug abuse
  18. Lack of co-operation or severe psychological disorders
  19. Institutionalisation by official or judicial order
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973453

Locations
Germany
Allergy & Asthma Center Westend
Berlin, Germany, D-14050
Hals, Nasen- und Ohrenheilkunde
Berlin, Germany, D-13057
Allergie-Centrum Charité, Klinik für Dermatologie, Venerologie und Allergologie, Charité Campus Mitte, Universitätsmedizin Berlin
Berlin, Germany, D-10117
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, D-40225
Allergologie HNO-Heilkunde
Schorndorf, Germany, D-73614
Klinik für Dermatologie und Allergie, Krankenhaus Bad Cannstatt
Stuttgart, Germany, D-70374
Sponsors and Collaborators
HAL Allergy
Investigators
Study Chair: Jörg Kleine-Tebbe, MD UZDAA, Untersuchungszentrum Dermatologie, Allergologie und Asthma, Berlin, Germany
  More Information

No publications provided

Responsible Party: HAL Allergy
ClinicalTrials.gov Identifier: NCT00973453     History of Changes
Other Study ID Numbers: PM/0028
Study First Received: September 7, 2009
Last Updated: September 9, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by HAL Allergy:
non-seasonal allergy
house dust mite
immunotherapy
dose tolerability

Additional relevant MeSH terms:
Rhinitis
Conjunctivitis, Allergic
Conjunctivitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on August 21, 2014