SUBLIVAC FIX Phleum Pratense DT/DRF

NCT ID: NCT01682070

Last Updated: 2013-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-05-31

Brief Summary

The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Phleum pratense based on reduction of upper airways reactivity after 5 months of treatment with different dosages of SUBLIVAC FIX Phleum pratense compared to placebo. Furthermore, safety and tolerability will be assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Phleum pratense compared to placebo.

Conditions

Allergic Rhinitis; Allergic Rhinoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SUBLIVAC FIX Phleum prat. 0 AUN/ml

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

SUBLIVAC FIX Phleum prat. 3,333 AUN/ml

Group Type: EXPERIMENTAL

SUBLIVAC FIX phleum prat.

Intervention Type: BIOLOGICAL

Comparison of different dosages to placebo

SUBLIVAC FIX phleum prat. 10,000 AUN/ml

Group Type: EXPERIMENTAL

SUBLIVAC FIX phleum prat.

Intervention Type: BIOLOGICAL

Comparison of different dosages to placebo

SUBLIVAC FIX phleum prat. 20,000 AUN/ml

Evaluation of the SUBLIVAC FIX Phleum prat. 20,000 AUN/ml by an independent safety committee

Group Type: EXPERIMENTAL

SUBLIVAC FIX phleum prat.

Intervention Type: BIOLOGICAL

Comparison of different dosages to placebo

SUBLIVAC FIX Phleum prat. 40,000 AUN/ml

Start of SUBLIVAC FIX Phleum prat. 40,000 AUN/ml arm depends on safety in the SUBLIVAC FIX Phleum prat. 20,000 AUN/ml arm evaluated by an independent safety committee

Group Type: EXPERIMENTAL

SUBLIVAC FIX phleum prat.

Intervention Type: BIOLOGICAL

Comparison of different dosages to placebo

Interventions

SUBLIVAC FIX phleum prat.

Comparison of different dosages to placebo

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Signed informed consent
• Age ≥ 18 ≤ 60 years
• Allergic rhinitis/rhinoconjunctivitis related to grass pollen with or without concomitant mild to moderate persistent asthma
• FEV1 > 70% for patients with a history of asthma, FEV > 70% or PEF > 80% for patients without a history of asthma
• A positive SPT (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for grass pollen assessed within 1 year before randomization.
• Positive serum specific anti-grass IgE-test (> 0.7 U/mL)
• A positive TNPT for grass pollen at screening (Lebel score ≥ 6) at ≤10,000 AU/mL

Exclusion Criteria

• Patients with (expected) clinically relevant symptoms during the course of the trial due to concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3mm) to allergens other than grass pollen
• Patients sensitized to pets should not be included if they are regularly exposed to pets and are symptomatic upon exposure to pets
• Completed immunotherapy (SCIT or SLIT) with grass pollen allergens within the past 5 years
• Completed unsuccessful specific immunotherapy in the past
• Vaccination within one week before start of therapy or during the initiation phase
• Anti-IgE therapy within the 6 months prior to inclusion and during the study
• Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
• Active malignancies or any malignant disease during the previous 5 years
• Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or haematological disorders
• Active inflammation or infection of the target organs (nose, eyes or lower airways) at the start of the study
• Moderate to severe nasal obstructive diseases that preclude a TNPT (septal deviation, nasal polyps, recent nasal surgery, etc.)
• Diseases with a contraindication for the use of Adrenaline (e.g. hyperthyroidism, glaucoma)
• Use of systemic steroids within 4 weeks before start of the study and during the study
• Treatment with systemic and local β-blockers
• Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study
• Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age (adequate contraceptive measures will be the use of a contraceptive device or -pill)
• Alcohol, drug or medication abuse within the past year
• Any clinically significant abnormal laboratory parameter at screening
• Lack of cooperation or compliance
• Severe psychiatric, psychological, or neurological disorders
• Patients who are employees of the institution or 1st grade relatives or partners of the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HAL Allergy

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter G. Canonica, Prof. Dr.

Role: STUDY_CHAIR

Allergy and Respiratory Diseases University of Genoa

Locations

CIMS Studienzentrum Bamberg

Bamberg, , Germany

Charité Universitaetsmedizin Berlin Klinik f. Dermatalogie, Venerologie u. Allergologie, Campus Charité Mitte

Berlin, , Germany

Klinik u. Poliklinik f. Dermatologie u. Allergologie Universität Bonn

Bonn, , Germany

Dermatologikum Hamburg - Dept. of Allergology

Hamburg, , Germany

HNO Praxis Dr. Horn/Dr. Zeuner

Heidelberg, , Germany

Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin

Hessen, , Germany

Dres.Ina Röhrig-Petering und Holger Petering

Hildesheim, , Germany

FÄ HNO Allergologie

Saalfeld, , Germany

Klinikum Stuttgart - Klinik f. Dermatologie u. Allergologie

Stuttgart, , Germany

Universitäts- Hautklinik Eberhard Karls - Universität Tübingen Department of Dermatology

Tübingen, , Germany

Dr. Med. Ulrich Neumann

Wolmirstedt, , Germany

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

Bialystok, , Poland

SP-ZOZ Ośrodek Zdrowia w Bieńkówce

Bieńkówka, , Poland

NZOS "Zdrowie"

Cieszyn, , Poland

Poradnia Alergologiczna Samodzielnego Publicznego Szpitala Nr 5 Slaskiego Uniwersytetu Medycznego w Katowicach

Katowice, , Poland

Poradnia Alergologii i Chorób Płuc SP ZOZ Uniwersytecki Szpital Kliniczny im Norberta Barlickiego w Łodzi

Lodz, , Poland

NZOZ Centrum Alergologii

Lodz, , Poland

ALERGOPNEUMA Marek Michnar i Wspolnicy Sp. Jawna

Lublin, , Poland

NZOZ Centrum Alergologii

Lublin, , Poland

Centrum Alergologii Teresa Hofman

Poznan, , Poland

ALERGOMED Specjalistyczna Przychodnia Lekarska Sp. z o.o.

Tarnów, , Poland

EMC Intytut Medyczny S.A. Przychodnia przy Łowieckiej

Wroclaw, , Poland

NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy

Wroclaw, , Poland

Countries

Germany; Poland

Other Identifiers

SP/0036

Identifier Type: -

Identifier Source: org_study_id