SUBLIVAC FIX Phleum Pratense DT/DRF

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HAL Allergy
ClinicalTrials.gov Identifier:
NCT01682070
First received: September 6, 2012
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Allergic Rhinitis
Allergic Rhinoconjunctivitis
Biological: SUBLIVAC FIX phleum prat.
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by HAL Allergy:

Primary Outcome Measures:
  • Nasal Provocation Test (NPT) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Number of related AEs [ Time Frame: First ten days of study medication intake ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum specific immunoglobulin levels (IgE, IgG, IgG4) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Number of local and systemic reactions [ Time Frame: Duration of study medication intake (approximately 5 months) ] [ Designated as safety issue: Yes ]
  • Peak Nasal Inspiratory Flow (PNIF) [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 266
Study Start Date: September 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682070

Locations
Germany
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
Poland
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
Investigators
Study Chair: Walter G. Canonica, Prof. Dr. Allergy and Respiratory Diseases University of Genoa
  More Information

No publications provided

Responsible Party: HAL Allergy
ClinicalTrials.gov Identifier: NCT01682070     History of Changes
Other Study ID Numbers: SP/0036
Study First Received: September 6, 2012
Last Updated: May 28, 2013
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Germany: Paul-Ehrlich-Institut

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

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

ClinicalTrials.gov processed this record on September 18, 2014