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

NCT00973453 | Completed Phase 2 DMC

• 1 other identifier: PM/0028
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 6

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

Conditions

Allergic Rhinitis; Allergic Rhinoconjunctivitis

Keywords

non-seasonal allergy; house dust mite; immunotherapy; dose tolerability

Outcome Measures

Primary Outcomes (1)

• 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.

  17, 14 or 11 weeks per patient for the respective groups

Secondary Outcomes (5)

• Late Local Reactions (LLR) occurring within 24 hours after injection, and systemic reactions (SR). General adverse events will be recorded during complete study period.

  17, 14 or 11 weeks per patient for the respective groups

• Clinical index score (CIS) during the study compared to baseline score (before treatment).

  weekly during per patient treatment periods of 17, 14 or 11 weeks for the respective groups

• Conjunctival provocation test one week after reaching 10,000 AUeq, 20,000 AUeq, or 40,000 AUeq for the respective groups compared to baseline.

  after 7 weeks of treatment

• Conjunctival provocation test 2 weeks after the patients have received two maintenance dosages compared to baseline score.

  17, 14 or 11 weeks for the respective treatment groups

• Specific IgE and IgG measured 2 weeks after the patients have received two maintenance dosages compared to baseline score.

  17, 14 or 11 weeks for the respective treatment groups

Study Arms (3)

Slow regimen

OTHER

Drug: PURETHAL Mites 20,000 AUeq/ml

Intermediate regimen

OTHER

Drug: PURETHAL Mites 20,000 AUeq/ml

Fast regimen

OTHER

Drug: PURETHAL Mites 20,000 AUeq/ml

Interventions

PURETHAL Mites 20,000 AUeq/ml DRUG

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.

Also known as: Immunotherapy for house dust mites allergy

Slow regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• HAL Allergy: lead

Study Sites (6)

Allergie-Centrum Charité, Klinik für Dermatologie, Venerologie und Allergologie, Charité Campus Mitte, Universitätsmedizin Berlin

Berlin, D-10117, Germany

Location

Hals, Nasen- und Ohrenheilkunde

Berlin, D-13057, Germany

Location

Allergy & Asthma Center Westend

Berlin, D-14050, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, D-40225, Germany

Location

Allergologie HNO-Heilkunde

Schorndorf, D-73614, Germany

Location

Klinik für Dermatologie und Allergie, Krankenhaus Bad Cannstatt

Stuttgart, D-70374, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Jörg Kleine-Tebbe, MD

  UZDAA, Untersuchungszentrum Dermatologie, Allergologie und Asthma, Berlin, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2009
• First Posted: September 9, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 12, 2011

Record last verified: 2011-09

Locations

DE (6)