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SUBLIVAC FIX Phleum Pratense DT/DRF

Primary Purpose

Allergic Rhinitis, Allergic Rhinoconjunctivitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SUBLIVAC FIX phleum prat.
Placebo
Sponsored by
HAL Allergy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Sublingual immunotherapy, Dose range finding, Dose tolerability, grass pollen, Allergic rhinitis/rhinoconjunctivitis, Safety, Immunogenicity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CIMS Studienzentrum Bamberg
  • Charité Universitaetsmedizin Berlin Klinik f. Dermatalogie, Venerologie u. Allergologie, Campus Charité Mitte
  • Klinik u. Poliklinik f. Dermatologie u. Allergologie Universität Bonn
  • Dermatologikum Hamburg - Dept. of Allergology
  • HNO Praxis Dr. Horn/Dr. Zeuner
  • Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin
  • Dres.Ina Röhrig-Petering und Holger Petering
  • FÄ HNO Allergologie
  • Klinikum Stuttgart - Klinik f. Dermatologie u. Allergologie
  • Universitäts- Hautklinik Eberhard Karls - Universität Tübingen Department of Dermatology
  • Dr. Med. Ulrich Neumann
  • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
  • SP-ZOZ Ośrodek Zdrowia w Bieńkówce
  • NZOS "Zdrowie"
  • Poradnia Alergologiczna Samodzielnego Publicznego Szpitala Nr 5 Slaskiego Uniwersytetu Medycznego w Katowicach
  • Poradnia Alergologii i Chorób Płuc SP ZOZ Uniwersytecki Szpital Kliniczny im Norberta Barlickiego w Łodzi
  • ALERGOPNEUMA Marek Michnar i Wspolnicy Sp. Jawna
  • NZOZ Centrum Alergologii
  • Centrum Alergologii Teresa Hofman
  • ALERGOMED Specjalistyczna Przychodnia Lekarska Sp. z o.o.
  • EMC Intytut Medyczny S.A. Przychodnia przy Łowieckiej
  • NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy
  • NZOZ Centrum Alergologii

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

SUBLIVAC FIX Phleum prat. 0 AUN/ml

SUBLIVAC FIX Phleum prat. 3,333 AUN/ml

SUBLIVAC FIX phleum prat. 10,000 AUN/ml

SUBLIVAC FIX phleum prat. 20,000 AUN/ml

SUBLIVAC FIX Phleum prat. 40,000 AUN/ml

Arm Description

Evaluation of the SUBLIVAC FIX Phleum prat. 20,000 AUN/ml by an independent safety committee

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

Outcomes

Primary Outcome Measures

Nasal Provocation Test (NPT)
Number of related AEs

Secondary Outcome Measures

Serum specific immunoglobulin levels (IgE, IgG, IgG4)
Number of local and systemic reactions
Peak Nasal Inspiratory Flow (PNIF)

Full Information

First Posted
September 6, 2012
Last Updated
May 28, 2013
Sponsor
HAL Allergy
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1. Study Identification

Unique Protocol Identification Number
NCT01682070
Brief Title
SUBLIVAC FIX Phleum Pratense DT/DRF
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 Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HAL Allergy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Keywords
Sublingual immunotherapy, Dose range finding, Dose tolerability, grass pollen, Allergic rhinitis/rhinoconjunctivitis, Safety, Immunogenicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SUBLIVAC FIX Phleum prat. 0 AUN/ml
Arm Type
Placebo Comparator
Arm Title
SUBLIVAC FIX Phleum prat. 3,333 AUN/ml
Arm Type
Experimental
Arm Title
SUBLIVAC FIX phleum prat. 10,000 AUN/ml
Arm Type
Experimental
Arm Title
SUBLIVAC FIX phleum prat. 20,000 AUN/ml
Arm Type
Experimental
Arm Description
Evaluation of the SUBLIVAC FIX Phleum prat. 20,000 AUN/ml by an independent safety committee
Arm Title
SUBLIVAC FIX Phleum prat. 40,000 AUN/ml
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
SUBLIVAC FIX phleum prat.
Intervention Description
Comparison of different dosages to placebo
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Nasal Provocation Test (NPT)
Time Frame
5 months
Title
Number of related AEs
Time Frame
First ten days of study medication intake
Secondary Outcome Measure Information:
Title
Serum specific immunoglobulin levels (IgE, IgG, IgG4)
Time Frame
5 months
Title
Number of local and systemic reactions
Time Frame
Duration of study medication intake (approximately 5 months)
Title
Peak Nasal Inspiratory Flow (PNIF)
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter G. Canonica, Prof. Dr.
Organizational Affiliation
Allergy and Respiratory Diseases University of Genoa
Official's Role
Study Chair
Facility Information:
Facility Name
CIMS Studienzentrum Bamberg
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Facility Name
Charité Universitaetsmedizin Berlin Klinik f. Dermatalogie, Venerologie u. Allergologie, Campus Charité Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinik u. Poliklinik f. Dermatologie u. Allergologie Universität Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Dermatologikum Hamburg - Dept. of Allergology
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
HNO Praxis Dr. Horn/Dr. Zeuner
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin
City
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Dres.Ina Röhrig-Petering und Holger Petering
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Facility Name
FÄ HNO Allergologie
City
Saalfeld /Saale
ZIP/Postal Code
07318
Country
Germany
Facility Name
Klinikum Stuttgart - Klinik f. Dermatologie u. Allergologie
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Facility Name
Universitäts- Hautklinik Eberhard Karls - Universität Tübingen Department of Dermatology
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Dr. Med. Ulrich Neumann
City
Wolmirstedt
ZIP/Postal Code
393 26
Country
Germany
Facility Name
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
City
Białystok
ZIP/Postal Code
15-430
Country
Poland
Facility Name
SP-ZOZ Ośrodek Zdrowia w Bieńkówce
City
Bieńkówka
ZIP/Postal Code
PL-34 212
Country
Poland
Facility Name
NZOS "Zdrowie"
City
Cieszyn
ZIP/Postal Code
43-400
Country
Poland
Facility Name
Poradnia Alergologiczna Samodzielnego Publicznego Szpitala Nr 5 Slaskiego Uniwersytetu Medycznego w Katowicach
City
Katowice
ZIP/Postal Code
40-952
Country
Poland
Facility Name
Poradnia Alergologii i Chorób Płuc SP ZOZ Uniwersytecki Szpital Kliniczny im Norberta Barlickiego w Łodzi
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
ALERGOPNEUMA Marek Michnar i Wspolnicy Sp. Jawna
City
Lublin
ZIP/Postal Code
20-089
Country
Poland
Facility Name
NZOZ Centrum Alergologii
City
Lublin
ZIP/Postal Code
20-522
Country
Poland
Facility Name
Centrum Alergologii Teresa Hofman
City
Poznań
ZIP/Postal Code
60-214
Country
Poland
Facility Name
ALERGOMED Specjalistyczna Przychodnia Lekarska Sp. z o.o.
City
Tarnów
ZIP/Postal Code
33-100
Country
Poland
Facility Name
EMC Intytut Medyczny S.A. Przychodnia przy Łowieckiej
City
Wrocław
ZIP/Postal Code
50-220
Country
Poland
Facility Name
NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy
City
Wrocław
ZIP/Postal Code
50-434
Country
Poland
Facility Name
NZOZ Centrum Alergologii
City
Łódź
ZIP/Postal Code
90-553
Country
Poland

12. IPD Sharing Statement

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SUBLIVAC FIX Phleum Pratense DT/DRF

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