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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01682070
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : May 29, 2013
Information provided by (Responsible Party):
HAL Allergy

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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Allergic Rhinoconjunctivitis Biological: SUBLIVAC FIX phleum prat. Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : September 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: SUBLIVAC FIX Phleum prat. 0 AUN/ml Biological: Placebo
Experimental: SUBLIVAC FIX Phleum prat. 3,333 AUN/ml Biological: SUBLIVAC FIX phleum prat.
Comparison of different dosages to placebo

Experimental: SUBLIVAC FIX phleum prat. 10,000 AUN/ml Biological: SUBLIVAC FIX phleum prat.
Comparison of different dosages to placebo

Experimental: SUBLIVAC FIX phleum prat. 20,000 AUN/ml
Evaluation of the SUBLIVAC FIX Phleum prat. 20,000 AUN/ml by an independent safety committee
Biological: SUBLIVAC FIX phleum prat.
Comparison of different dosages to placebo

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

Primary Outcome Measures :
  1. Nasal Provocation Test (NPT) [ Time Frame: 5 months ]
  2. Number of related AEs [ Time Frame: First ten days of study medication intake ]

Secondary Outcome Measures :
  1. Serum specific immunoglobulin levels (IgE, IgG, IgG4) [ Time Frame: 5 months ]
  2. Number of local and systemic reactions [ Time Frame: Duration of study medication intake (approximately 5 months) ]
  3. Peak Nasal Inspiratory Flow (PNIF) [ Time Frame: 5 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01682070

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CIMS Studienzentrum Bamberg
Bamberg, Germany, 96049
Charité Universitaetsmedizin Berlin Klinik f. Dermatalogie, Venerologie u. Allergologie, Campus Charité Mitte
Berlin, Germany, 10117
Klinik u. Poliklinik f. Dermatologie u. Allergologie Universität Bonn
Bonn, Germany, 53105
Dermatologikum Hamburg - Dept. of Allergology
Hamburg, Germany, 20354
HNO Praxis Dr. Horn/Dr. Zeuner
Heidelberg, Germany, 69120
Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin
Hessen, Germany, 60590
Dres.Ina Röhrig-Petering und Holger Petering
Hildesheim, Germany, 31134
FÄ HNO Allergologie
Saalfeld /Saale, Germany, 07318
Klinikum Stuttgart - Klinik f. Dermatologie u. Allergologie
Stuttgart, Germany, 70174
Universitäts- Hautklinik Eberhard Karls - Universität Tübingen Department of Dermatology
Tübingen, Germany, 72076
Dr. Med. Ulrich Neumann
Wolmirstedt, Germany, 393 26
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
Białystok, Poland, 15-430
SP-ZOZ Ośrodek Zdrowia w Bieńkówce
Bieńkówka, Poland, PL-34 212
NZOS "Zdrowie"
Cieszyn, Poland, 43-400
Poradnia Alergologiczna Samodzielnego Publicznego Szpitala Nr 5 Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, Poland, 40-952
Poradnia Alergologii i Chorób Płuc SP ZOZ Uniwersytecki Szpital Kliniczny im Norberta Barlickiego w Łodzi
Lodz, Poland, 90-153
ALERGOPNEUMA Marek Michnar i Wspolnicy Sp. Jawna
Lublin, Poland, 20-089
NZOZ Centrum Alergologii
Lublin, Poland, 20-522
Centrum Alergologii Teresa Hofman
Poznań, Poland, 60-214
ALERGOMED Specjalistyczna Przychodnia Lekarska Sp. z o.o.
Tarnów, Poland, 33-100
EMC Intytut Medyczny S.A. Przychodnia przy Łowieckiej
Wrocław, Poland, 50-220
NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy
Wrocław, Poland, 50-434
NZOZ Centrum Alergologii
Łódź, Poland, 90-553
Sponsors and Collaborators
HAL Allergy
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Study Chair: Walter G. Canonica, Prof. Dr. Allergy and Respiratory Diseases University of Genoa

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Responsible Party: HAL Allergy Identifier: NCT01682070     History of Changes
Other Study ID Numbers: SP/0036
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013

Keywords provided by HAL Allergy:
Sublingual immunotherapy
Dose range finding
Dose tolerability
grass pollen
Allergic rhinitis/rhinoconjunctivitis

Additional relevant MeSH terms:
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Rhinitis, Allergic
Conjunctivitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Conjunctival Diseases
Eye Diseases