SUBLIVAC FIX Birch Dose Tolerability/Dose Range Finding

NCT ID: NCT01639768

Last Updated: 2013-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-04-30

Brief Summary

The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Birch based on reduction of upper airways reactivity after 5 months of treatment with different dosages of SUBLIVAC FIX Birch compared to placebo. Furthermore, safety and tolerability will be assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Birch 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 Birch 0 AUN/ml

Group Type: PLACEBO_COMPARATOR

SUBLIVAC FIX Birch

Intervention Type: DRUG

Comparison of different dosages to placebo

SUBLIVAC FIX Birch 3,333 AUN/ml

Group Type: ACTIVE_COMPARATOR

SUBLIVAC FIX Birch

Intervention Type: DRUG

Comparison of different dosages to placebo

SUBLIVAC FIX Birch 10,000 AUN/ml

Group Type: ACTIVE_COMPARATOR

SUBLIVAC FIX Birch

Intervention Type: DRUG

Comparison of different dosages to placebo

SUBLIVAC FIX Birch 20,000 AUN/ml

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

Group Type: ACTIVE_COMPARATOR

SUBLIVAC FIX Birch

Intervention Type: DRUG

Comparison of different dosages to placebo

SUBLIVAC FIX Birch 40,000 AUN/ml

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

Group Type: ACTIVE_COMPARATOR

SUBLIVAC FIX Birch

Intervention Type: DRUG

Comparison of different dosages to placebo

Interventions

SUBLIVAC FIX Birch

Comparison of different dosages to placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed informed consent
• Age ≥ 18 ≤ 60 years
• Allergic rhinitis/rhinoconjunctivitis related to birch 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 birch pollen assessed within

1 year before randomization.

• Positive serum specific anti-birch IgE-test (> 0.7 U/mL)
• A positive TNPT for birch 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 birch 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 birch 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

Oliver Pfaar, PD. Dr. med.

Role: STUDY_CHAIR

Zentrum für Rhinologie und Allergologie, An-den-Quellen-10, 65189 Wiesbaden, Germany

Locations

AKI, spol s. r.o.

Brno, , Czechia

Ordinace Alergologie

Most, , Czechia

Respiral s. r.o.

Pilsen, , Czechia

Ústav imunologie a alergologie

Pilsen, , Czechia

Kasmed s. r.o.

Tábor, , Czechia

Praxis für Atemwegserkrankungen

Leipzig, Saxony, Germany

Medizinische Fakultät. Klinik und Poliklinik für HNO-Klinik

Dresden, , Germany

HNO-Wiesbaden - Center for Rhinology and Allergology

Wiesbaden, , Germany

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

Bialystok, , Poland

NZOS "Zdrowie"

Cieszyn, , Poland

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

Katowice, , Poland

Specjalistyczny Ośrodek Alergologiczno-Internistyczny "ALL-MED"

Krakow, , Poland

Poradnia Alergologii i Chorób Płuc SP ZOZ Uniwersytecki Szpital Kliniczny Nr.1 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

Czechia; Germany; Poland

References

Pfaar O, van Twuijver E, Boot JD, Opstelten DJ, Klimek L, van Ree R, Diamant Z, Kuna P, Panzner P. A randomized DBPC trial to determine the optimal effective and safe dose of a SLIT-birch pollen extract for the treatment of allergic rhinitis: results of a phase II study. Allergy. 2016 Jan;71(1):99-107. doi: 10.1111/all.12760. Epub 2015 Oct 26.

Reference Type: DERIVED

PMID: 26417901 (View on PubMed)

Other Identifiers

SB/0038

Identifier Type: -

Identifier Source: org_study_id