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Allergic Rhinitis and/or Rhinoconjunctivitis +- AsthmaPhase 2NCT01144429

Dose Finding Study for Depigoid Birch: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma

A Phase 2 study testing Allergoid, allergenic extract of 100% Birch in people with Allergic Rhinitis and/or Rhinoconjunctivitis +- Asthma and Immunotherapy, Allergen, run by Leti Pharma GmbH at 39 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Specific immunotherapy for subcutaneous application: Dose finding study to evaluate the correct dose. 4 concentrations of a birch pollen allergen extract are applied in this study. Duration of therapy 20 weeks. Primary criterion is the Conjunctival Provocation Test (CPT), i.e. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Allergoid, allergenic extract of 100% Birch
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
344 participants
Where
39 sitesin 3 countries
Study dates
Jun 2010to May 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients have provided an appropriately signed and dated informed consent prior to any study specific examination,
  • Patients must be ≥ 18 and ≤ 70 years of age at Visit 1,
  • Patients must have a perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS),
  • Patients must have an FEV1 or PEF value > 80% of the predicted normal value (for PEF: highest result of 3 measurements),
  • Patients must complain about allergic rhinitis and/or rhinoconjunctivitis symptoms for at least 2 years with or without intermittent asthma symptoms, caused by clinical sensitization against birch pollen,
  • IgE-mediated sensitization has to be verified by:
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  • suggestive medical history, and
  • specific IgE against birch pollen (CAP-Rast ≥ 2), and
  • a positive SPT to birch pollen (the SPT is considered positive if it results in a wheal diameter of at least 3 mm and at least the size of histamine reference), and
  • a positive CPT with a birch pollen concentration of up to 10,000 SQ-units/mL.
  • Special criteria for patients with co-allergies
  • Patients do not suffer from typical symptoms against co-allergens,
  • Specific CAP-RAST against co-allergens < CAP-RAST against birch pollen (the difference has to be ≥ 2), patients with co-allergens against animal dander can be randomized even if the CAP RAST difference is < 2, but must not be exposed to the specific allergen,
  • Result of SPT against co-allergens < result of SPT against birch pollen.

Who cannot join

  • Acute and chronic conjunctivitis,
  • Infectious conjunctivitis,
  • History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens (e.g. house dust mites),
  • Symptoms due to co-allergies,
  • Persistent asthma, according to the Global Initiative for Asthma (GINA) Guidelines,
  • Acute or chronic inflammatory or infectious airway diseases including recurrent acute or chronic sinusitis,
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  • Chronic structural diseases of the lung (e.g. emphysema or bronchiectasis),
  • Diseases of the immune system including autoimmune and immune deficiencies,
  • Any disease, which prohibits the use of adrenaline (e.g. hyperthyroidism),
  • Severe uncontrolled diseases that could increase the risk for the patients participating in the study, which include but are not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or hematological disorders,
  • Any malignant disease during the previous 5 years,
  • Any significant abnormal laboratory parameter or alteration in the vital signs that could increase the risk for the study patient,
  • Alcohol, drug, or medication abuse within the past year,
  • Severe psychiatric, psychological, or neurological disorders,
  • Use of immunotherapy against birch pollen within the last 5 years,
  • Topical and systemic treatment with β-blockers,
  • Treatment with substances interfering with the immune system within 1 week prior to Visit 2,
  • Use of tranquillizers or psychoactive drugs within 1 week prior to Visit 1,
  • Use of systemic corticosteroids within 3 months prior to Visit 1,
  • Immunization with vaccines within 7 days prior to Visit 2,
  • Patients with hypersensitivity to excipients of the investigational medicinal product,
  • Patients expected to be non-compliant and/or not co-operative,
  • Exposure to any investigational drug within one month or 6 half lives,
  • Patients who have already participated in this study,
  • Patients who are employees of the institution, or 1st grade relatives, or partners of the investigator,
  • Any donation of germ cells, blood, organs, or bone marrow during the course of the study,
  • Patients who are not contractually capable,
  • Nursing (lactating) women or a positive pregnancy test at Visit 1.
  • Persons who are jurisdictional or governmentally institutionalized.

Trial locations and contacts

39 sites in 3 countries.

39 sites in 3 countries

Germany25 sites

  • Dermatology Weber

    Augsburg, 86163

  • Licca Klinik Dermatologie

    Augsburg, 86179

  • Allergie-Centrum-Charité

    Berlin, 10117

  • Klinische Froschung Berlin Mitte

    Berlin, 10117

  • Hippke, Ear-Nose-Throat Specialist and Allergy

    Berlin, 13057

  • Universität Bonn, Klinik und Poliklinik für Dermatologie

    Bonn, 53127

  • Klinikum Carl-Gustav Carus, Klinik+Poliklinik für HNO

    Dresden, 01307

  • Thieme, Ear-Nose-Throat Specialist and Allergology

    Duisburg, 47051

  • Dominicus Hautzentrum

    Dülmen, 48249

  • Spaeth, Ear-Nose-Throat Specialist and Allergy

    Düren, 52351

  • Klinische Forschung Hamburg GmbH

    Hamburg, 20253

  • Clinical Research Hamburg GmbH

    Hamburg, 22143

  • Stefan, Dermatology and Allergy

    Hennef (Sieg), 53773

  • Feussner, Pulmology and Allergology

    Kassel, 34121

  • Tagesklinik für Allergie und Hautkrankheiten Brüning

    Kiel, 24148

  • Zentrum für Therapiestudien der Innomed Leipzig GmbH

    Leipzig, 04103

  • Medamed GmbH Studienambulanz

    Leipzig, 04109

  • Amann, Ear-Nose-Throat Specialist and Allergy

    Lingen, 49809

  • CRC Universitätsklinikum Mainz

    Mainz, 55131

  • Universität, Klinik und Poliklinik für Hautkrankheiten

    Münster, 48149

  • Ear-Nose-Throat Specialist Schaefer

    Pirna, 01796

  • Palm, Ear-Nose-Throat, Allergology

    Röthenbach, 90552

  • Steinborn Dermatology

    Straubing, 94315

  • Zentrum für Rhinologie und Allergie

    Wiesbaden, 65183

  • Hautarztpraxis Allergie Hoffmann

    Witten, 58453

Other trials in Germany

Poland11 sites

  • Zakład Alergologii, SPZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 31531

  • Klinika Pulmonologii i Alergologii, SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. N. Barlickiego UM w Łodzi

    Lodz, 90153

  • NZOZ Centrum Alergologii

    Lodz, 90553

  • CSK UM w Łodzi, Klinika Immunologii, Reumatologii i Alergii, Zakład Immunologii Klinicznej

    Lodz, 92213

  • Centrum Alergologii

    Poznan, 60214

  • Alergologia Plus, Specjalistyczny NZOZ, Ośrodek Diagnostyki i Terapii Uczuleń

    Poznan, 60693

  • NZOZ Alergo-Med.

    Poznan, 60823

  • Alergo-Med. Specjalistyczna Przychodnia Lekarska Sp. z o. o.

    Tarnów, 33100

  • Poradnia Alergologiczna, Gabinet Lekarski

    Tomaszów Mazowiecki, 97200

  • NZOZ Almed Specjalistyczna Opieka Medyczna

    Wroclaw, 50445

  • NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy

    Wroclaw, 54239

Other trials in Poland

Lithuania3 sites

  • Kaunas Distric Hospital

    Kaunas, 45130

  • Kaunas Medical University Clinics

    Kaunas, 50009

  • ENT Clinic "Trirema Medica"

    Vilnius, 1113

Other trials in Lithuania

About this study

Official title: Randomized, DB, Parallel Group, MC Study to Evaluate the Efficacy and Safety of Four Doses of Depigmented Glutaraldehyde Polymerized Birch Pollen Allergenic Extract (Depigoid Birch) in Patients With Allergic Rhinitis and/or Rhinoconjunctivitis With or Without Intermittent Asthma

Specific immunotherapy for subcutaneous application: Dose finding study to evaluate the correct dose.

4 concentrations of a birch pollen allergen extract are applied in this study. Duration of therapy 20 weeks. Primary criterion is the Conjunctival Provocation Test (CPT), i.e. comparison between treatment arms of increased amount of quantities of allergen to provoke a positive CPT at the end of treatment.

Read the detailed description

This is a dose finding study and no therapeutic study. Patients will receive in 4-weekly intervals 5x injections of 0,5 ml of a solution of modified birch pollen extract outside the pollen season. The primary endpoint therefore is not the therapeutic effect of the specific immunotherapy (effect on symptoms of allergy during the birch pollen season) but the effect on the CPT. Acc. to the EMEA "Guideline on clinical development of products for specific immunotherapy for the treatment of allergic diseases" provocation tests are accepted as primary outcomes for dose-finding studies.

For the CPT increasing doses of birch pollen solutions are applied to the eye and characteristic symptoms (eye redness, weeping, itching or burning and nose dripping/blockage) are assessed: 0 = absent, 1=mild, 2=moderate, 3=severe). At a score value of >= 5/concentration the test is considered positive and finished.

It is expected that at the end of the study higher doses are necessary to provoke a positive CPT.

Furthermore comparative evaluation of the safety data (AEs) in the different dosage groups is a very important parameter for the evaluation of the outcome of the study.

Being tested
Allergoid, allergenic extract of 100% Birch
Keywords
Allergic Rhinitis +- intermittent asthma, Allergic Rhinoconjunctivitis +- intermittent asthma, Specific Immunotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allergoid, allergenic extract of 100% BirchBiological

    Also called Depigoid (R), Depigmented, glutaraldehyd-polymerized allergenic extract of

    Subcutaneous injections Build-up = 1 day: 0,1mL + 0,2mL + 0,2mL s.c. in intervals on 30 minutes; Maintenance = 5 x single injection of 0,5 mL s.c. every 4 weeks

Study groups in NCT01144429
Study groupRoleWhat they receive
100 DPP/mLActive comparatorConcentration of solution fo s.c. injection: 100 DPP/mL
Receives: Biological: Allergoid, allergenic extract of 100% Birch
1000 DPP/mLActive comparatorConcentration of solution fo s.c. injection: 1000 DPP/mL
Receives: Biological: Allergoid, allergenic extract of 100% Birch
5000 DPP/mLActive comparatorConcentration of solution fo s.c. injection: 5000 DPP/mL
Receives: Biological: Allergoid, allergenic extract of 100% Birch
10000 DPP/mLActive comparatorConcentration of solution fo s.c. injection: 10000 DPP/mL
Receives: Biological: Allergoid, allergenic extract of 100% Birch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Conjunctival Provocation Test

    Comparison between dosage groups of percentage of patients who need an increased amount of allergen to provoke a positive CPT at the end of the treatment (comparison of slope of efficacy) It is expected that at the end of the study higher doses are necessary to provoke a positive CPT.

    Acc. to the EMEA "Guideline on clinical development of products for specific immunotherapy for the treatment of allergic diseases" provocation tests are accepted as primary outcomes for dose-finding studies.

    Measured: At screening and after approx 22 weeks (EoS)

Secondary outcomes (8)

  1. Laboratory parameters (immunology)

    specific IgE (Birch), specific IgG1 and IgG4 (Birch). Comparison pre-post will be evaluated

    Measured: At screening and after approx. 22 weeks (EoS)

  2. Conjunctival Provocation Test

    Analysis of individual results for allergen amount

    Measured: after approx. 22 weeks

  3. Laboratory (hematological, clinical chemistry, immunological) as a measure of safety

    Clinically relevant changes need to be documented as AE. Comparison pre-post will be displayed descriptively.

    Measured: At screening and after approx. 22 weeks (EoS)

  4. Overall assessment of safety (tolerability)at the end of the study

    At the end of the study investigator and patient will give their general overall impression on the safety of the study treatment on the following scale: excellent (no side effects at all), good (some minor local side effects), moderate (major local side effects or mild systemic side effects) or unaccaptable (anaphylactic reaction).

    Results will be compared between dosage groups

    Measured: after approx. 22 weeks (EoS)

  5. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    AEs are recorded at the study visits (patients are questioned and the patient diary - where allergy specific symptoms should be recorded by the patients during 48 hrs after each injection of IMP - is assessed by the investigator and AEs recorded in the CRF if applicable) and at any time of the study when site becomes aware of an AE/SAE.

    AE/SAE rate is compared between the treatment groups (safety profile). Also rates of local and systemic reactions will be calculated

    Measured: at 4-weekly intervals (retrospectively at study visits)

  6. Vital signs: Blood pressure and Heart rate as a measure of safety

    Vital signs are measured a screening and every study visit. Clinically abnormal values must be assessed by the investigator and - if applicable - documented as AE. Vital signs will be evaluated descriptively

    Measured: At screening and every study visit (4-weekly)

  7. Patient diary: Allergy specific symptoms and concomitant medication (rescue m.) for 48 hrs after application of study medication

    Symptoms: urticaria, sneezing, runny nose, cough, dizziness, asthma symptoms, swelling/pain at the injection site.

    Symptoms documented in the diary will be judged and assessed by the investigator and transcribed as AE into the CRF if applicable Medication: Antihistaminics (Eye drops, nose spray), Sultanol, oral corticosteroids, other Intake of medication documented by the patients has to be transcribed to the CRF (Concomitant medication section)

    Measured: 48 hrs every 4 weeks after each application of study medication

  8. Physical examination acc to local procedures as a measure of safety

    A PE has to be performed at screening and end of study visit (22 weeks). Clinically abnormal findings must be assessed by the investigator and documented as AE if applicable. Data will be evaluated descriptively

    Measured: At screening and after approx. 22 weeks (EoS)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionFeb 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01144429
Sponsor's protocol ID
603-PG-PSC-173
Other IDs
2008-008448-26, 2008
Status last verified
Jun 2011
First submitted
10 Jun 2010
Last updated
8 Jun 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Allergoid, allergenic extract of 100% Birch in people with Allergic Rhinitis and/or Rhinoconjunctivitis +- Asthma and Immunotherapy, Allergen, run by Leti Pharma GmbH at 39 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Germany, Poland, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conjunctival Provocation Test (time frame: At screening and after approx 22 weeks (EoS)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01144429.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.

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