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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01682070
Other study ID # SP/0036
Secondary ID
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


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
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