SUBLIVAC FIX Phleum Pratense DT/DRF

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 Phleum Pratense in Patients With Allergic Rhinitis/Rhinoconjunctivitis Caused by Grass Pollen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682070
• Other study ID #: SP/0036
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2012
• Last updated: May 28, 2013
• Start date: September 2012
• Est. completion date: May 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 ProductsGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: May 2013
• Est. primary completion date: May 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 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 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

Biological:
• SUBLIVAC FIX phleum prat.
Comparison of different dosages to placebo
• Placebo

Locations

Country	Name	City	State
Germany	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 /Saale
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
Poland	Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny	Bialystok
Poland	SP-ZOZ Osrodek Zdrowia w Bienkówce	Bienkówka
Poland	NZOS "Zdrowie"	Cieszyn
Poland	Poradnia Alergologiczna Samodzielnego Publicznego Szpitala Nr 5 Slaskiego Uniwersytetu Medycznego w Katowicach	Katowice
Poland	Poradnia Alergologii i Chorób Pluc SP ZOZ Uniwersytecki Szpital Kliniczny 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

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