PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis

PHASE2CompletedINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

May 31, 2013

Study Completion Date

May 31, 2013

Conditions
Allergic RhinitisAllergic Rhinoconjunctivitis
Interventions
BIOLOGICAL

Placebo

Increasing volumes of placebo, will be administered by subcutaneous injection (starting with 0.05 ml) at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of placebo, are given at 4-weekly intervals.

BIOLOGICAL

PURETHAL Mites 6,667 AU/ml

Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.

BIOLOGICAL

PURETHAL Mites 20,000 AU/ml

Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.

BIOLOGICAL

PURETHAL Mites 50,000 AU/ml

Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.

BIOLOGICAL

PURETHAL Mites 100,000 AU/ml

Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.

Trial Locations (35)

46026

Hospital Universitari Politecnic La Fe, Valencia

A-6020

Univ.-Klinik für Dermatologie und Venerologie, Innsbruck

Universitätsklinik für Hals -, Nasen - und Ohrenheilkunde, Innsbruck

B-9000

UZ Gent, Ghent

B-3000

UZ Leuven campus Sint Rafaël, Leuven

B-4000

CHU de Liège, Liège

D-13057

HNO-Praxis Dr. Hippke, Berlin

D-53127

Universitätsklinikum Bonn, Bonn

D-09130

HNO-Praxis, Chemnitz

D-44263

Gemeinschaftspraxis Pneumologie und Allergologie Dr. Hans-Christian Blum, Dortmund

D-47051

HNO-Praxis Dr. U. Thieme, Duisburg

D-52351

Medizinisches Versorgungszentrum, Düren

D-91052

Universitätsklinikum Erlangen, Erlangen

D-37073

HNO Gemeinschaftspraxis, Göttingen

D-30167

Pneumologische Praxis Hannover Nordstadt, Hanover

D-69126

HNO Gemeinschaftspraxis, Heidelberg

D-52428

HNO-Praxis, Jülich

D-04357

POIS Leipzig GbR, Leipzig

D-68167

CRS Clinical Research Services Mannheim GmbH, Mannheim

D-41061

CRS Clinical Research Services Möchengladbach GmbH, Mönchengladbach

D-80331

Gemeinschaftspraxis HNO/Allergologie, München

D-80337

Klinikum der Universität München, München

D-80539

Pneumologie Odeonsplatz, München

D-01796

HNO-Praxis, Pirna

D-73614

Praxisgemeinschaft Reiber & Partner, Schorndorf

D-70374

Universitätsklinikum Stuttgart, Stuttgart

D-70499

Hautarztpraxis, Stuttgart

D-65183

Zentrum für Rhinologie und Allergologie, Wiesbaden

NL-1311 RL

EB FlevoResearch, Almere Stad

NL-6824 BJ

Allergologie Praktijk Arnhem (APA), Arnhem

NL-3317 NM

Albert Schweitzer (Amstelwijck), Dordrecht

NL-9713 GZ

QPS Onderzoekskliniek Universitair Medisch Centrum Groningen, Groningen

NL-5022 GC

St. Elisabethziekenhuis, Tilburg

08036

Hospital Clinico Barcelona, Barcelona

08916

Hospital Universitario Germans Trios i Pujol, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

HAL Allergy

INDUSTRY

NCT01438463 - PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis | Biotech Hunter | Biotech Hunter