SUBLIVAC FIX Birch Dose Tolerability/Dose Range Finding

May 28, 2013 updated by: HAL Allergy

A Randomized, Double-blind, Placebo-controlled Study to Determine Safety, Tolerability and the Optimal Effective Dose of SUBLIVAC FIX Birch in Patients With Allergic Rhinitis/Rhinoconjunctivitis Caused by Birch Pollen

The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Birch based on reduction of upper airways reactivity after 5 months of treatment with different dosages of SUBLIVAC FIX Birch compared to placebo. Furthermore, safety and tolerability will be assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Birch compared to placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 639 00
        • AKI, spol s. r.o.
      • Most, Czech Republic, 434 01
        • Ordinace Alergologie
      • Plzeň, Czech Republic, 301 00
        • Respiral s. r.o.
      • Plzeň, Czech Republic, 304 60
        • Ustav imunologie a alergologie
      • Tábor, Czech Republic, 390 01
        • Kasmed s. r.o.
  • Germany
      • Dresden, Germany, 01062
        • Medizinische Fakultät. Klinik und Poliklinik für HNO-Klinik
      • Wiesbaden, Germany, 65183
        • HNO-Wiesbaden - Center for Rhinology and Allergology
    • Sachsen
      • Leipzig, Sachsen, Germany, 04275
        • Praxis fur Atemwegserkrankungen
  • Poland
      • Białystok, Poland, 15-430
        • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
      • Cieszyn, Poland, 43-400
        • NZOS "Zdrowie"
      • Katowice, Poland, 40-952
        • Poradnia Alergologiczna Samodzielnego Publicznego Szpitala Nr 5 Slaskiego Uniwersytetu Medycznego w Katowicach
      • Kraków, Poland, 31-023
        • Specjalistyczny Ośrodek Alergologiczno-Internistyczny "ALL-MED"
      • Lodz, Poland, 90-153
        • Poradnia Alergologii i Chorób Płuc SP ZOZ Uniwersytecki Szpital Kliniczny Nr.1 im. Norberta Barlickiego w Łodzi
      • Lublin, Poland, 20-089
        • ALERGOPNEUMA Marek Michnar i Wspolnicy Sp. Jawna
      • Lublin, Poland, 20-522
        • Nzoz Centrum Alergologii
      • Poznań, Poland, 60-214
        • Centrum Alergologii Teresa Hofman
      • Tarnów, Poland, 33-100
        • ALERGOMED Specjalistyczna Przychodnia Lekarska Sp. z o.o.
      • Wrocław, Poland, 50-220
        • EMC Intytut Medyczny S.A. Przychodnia przy Łowieckiej
      • Wrocław, Poland, 50-434
        • NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy
      • Łódź, Poland, 90-553
        • Nzoz Centrum Alergologii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent
  • Age ≥ 18 ≤ 60 years
  • Allergic rhinitis/rhinoconjunctivitis related to birch 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 birch pollen assessed within

    1 year before randomization.

  • Positive serum specific anti-birch IgE-test (> 0.7 U/mL)

  • A positive TNPT for birch 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 birch 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 birch 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: SUBLIVAC FIX Birch 0 AUN/ml
Drug: SUBLIVAC FIX Birch
Comparison of different dosages to placebo
Active Comparator: SUBLIVAC FIX Birch 3,333 AUN/ml
Drug: SUBLIVAC FIX Birch
Comparison of different dosages to placebo
Active Comparator: SUBLIVAC FIX Birch 10,000 AUN/ml
Drug: SUBLIVAC FIX Birch
Comparison of different dosages to placebo
Active Comparator: SUBLIVAC FIX Birch 20,000 AUN/ml
Evaluation of the SUBLIVAC FIX Birch 20,000 AUN/ml by an independent safety committee
Drug: SUBLIVAC FIX Birch
Comparison of different dosages to placebo
Active Comparator: SUBLIVAC FIX Birch 40,000 AUN/ml
Start of SUBLIVAC FIX Birch 40,000 AUN/ml arm depends on safety in the SUBLIVAC FIX Birch 20,000 AUN/ml arm evaluated by an independent safety committee
Drug: SUBLIVAC FIX Birch
Comparison of different dosages to placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Nasal Provocation Test (NPT)
Time Frame: 5 months
5 months
Number of related AEs
Time Frame: First ten days of study medication intake
First ten days of study medication intake

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Serum specific immunoglobulin levels (IgE, IgG, IgG4)
Time Frame: 5 months
5 months
Number of local and systemic reactions
Time Frame: Duration of study medication intake (approximately 5 months)
Duration of study medication intake (approximately 5 months)
Peak Nasal Inspiratory Flow (PNIF)
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HAL Allergy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Oliver Pfaar, PD. Dr. med., Zentrum für Rhinologie und Allergologie, An-den-Quellen-10, 65189 Wiesbaden, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SB/0038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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