SUBLIVAC FIX Birch Dose Tolerability/Dose Range Finding

Allergic Rhinitis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study to Determine Safety, Tolerability and the Optimal Effective Dose of SUBLIVAC FIX Birch in Patients With Allergic Rhinitis/Rhinoconjunctivitis Caused by Birch Pollen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639768
• Other study ID #: SB/0038
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2012
• Last updated: May 28, 2013
• Start date: July 2012
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: HAL Allergy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsCzech Republic: State Institute for Drug ControlGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 ß-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Allergic Rhinoconjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic
• Rhinitis

Intervention

Drug:
• SUBLIVAC FIX Birch
Comparison of different dosages to placebo

Locations

Country	Name	City	State
Czech Republic	AKI, spol s. r.o.	Brno
Czech Republic	Ordinace Alergologie	Most
Czech Republic	Respiral s. r.o.	Plzen
Czech Republic	Ústav imunologie a alergologie	Plzen
Czech Republic	Kasmed s. r.o.	Tábor
Germany	Medizinische Fakultät. Klinik und Poliklinik für HNO-Klinik	Dresden
Germany	Praxis für Atemwegserkrankungen	Leipzig	Sachsen
Germany	HNO-Wiesbaden - Center for Rhinology and Allergology	Wiesbaden
Poland	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 Osrodek Alergologiczno-Internistyczny "ALL-MED"	Kraków
Poland	Poradnia Alergologii i Chorób Pluc SP ZOZ Uniwersytecki Szpital Kliniczny Nr.1 im. Norberta Barlickiego w Lodzi	Lodz
Poland	NZOZ Centrum Alergologii	Lódz
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 Lowieckiej	Wroclaw
Poland	NZOZ Lekarze Specjalisci J. Malolepszy i Partnerzy	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
HAL Allergy

Countries where clinical trial is conducted

Czech Republic,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal Provocation Test (NPT)		5 months	No
Primary	Number of related AEs		First ten days of study medication intake	Yes
Secondary	Serum specific immunoglobulin levels (IgE, IgG, IgG4)		5 months	No
Secondary	Number of local and systemic reactions		Duration of study medication intake (approximately 5 months)	Yes
Secondary	Peak Nasal Inspiratory Flow (PNIF)		5 months	No