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

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2010

Conditions
Allergic RhinitisAllergic Rhinoconjunctivitis
Interventions
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."

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."

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."

Trial Locations (6)

D-10117

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

D-13057

Hals, Nasen- und Ohrenheilkunde, Berlin

D-14050

Allergy & Asthma Center Westend, Berlin

D-40225

Universitätsklinikum Düsseldorf, Düsseldorf

D-73614

Allergologie HNO-Heilkunde, Schorndorf

D-70374

Klinik für Dermatologie und Allergie, Krankenhaus Bad Cannstatt, Stuttgart

Sponsors

Lead Sponsor

All Listed Sponsors
lead

HAL Allergy

INDUSTRY

NCT00973453 - Study With High Dose PURETHAL Mites in Allergic Rhinitis/Rhinoconjunctivitis Patients | Biotech Hunter | Biotech Hunter