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Allergic RhinitisPhase 2NCT01682070

SUBLIVAC FIX Phleum Pratense DT/DRF

A Phase 2 study testing SUBLIVAC FIX phleum prat. in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by HAL Allergy at 23 sites in 2 countries.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
SUBLIVAC FIX phleum prat.
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
266 participants
Where
23 sitesin 2 countries
Study dates
Sep 2012to May 2013
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

Poland12 sites

  • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

    Bialystok, 15-430

  • SP-ZOZ Ośrodek Zdrowia w Bieńkówce

    Bieńkówka, PL-34 212

  • NZOS "Zdrowie"

    Cieszyn, 43-400

  • Poradnia Alergologiczna Samodzielnego Publicznego Szpitala Nr 5 Slaskiego Uniwersytetu Medycznego w Katowicach

    Katowice, 40-952

  • Poradnia Alergologii i Chorób Płuc SP ZOZ Uniwersytecki Szpital Kliniczny im Norberta Barlickiego w Łodzi

    Lodz, 90-153

  • NZOZ Centrum Alergologii

    Lodz, 90-553

  • ALERGOPNEUMA Marek Michnar i Wspolnicy Sp. Jawna

    Lublin, 20-089

  • NZOZ Centrum Alergologii

    Lublin, 20-522

  • Centrum Alergologii Teresa Hofman

    Poznan, 60-214

  • ALERGOMED Specjalistyczna Przychodnia Lekarska Sp. z o.o.

    Tarnów, 33-100

  • EMC Intytut Medyczny S.A. Przychodnia przy Łowieckiej

    Wroclaw, 50-220

  • NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy

    Wroclaw, 50-434

Other trials in Poland

Germany11 sites

  • CIMS Studienzentrum Bamberg

    Bamberg, 96049

  • Charité Universitaetsmedizin Berlin Klinik f. Dermatalogie, Venerologie u. Allergologie, Campus Charité Mitte

    Berlin, 10117

  • Klinik u. Poliklinik f. Dermatologie u. Allergologie Universität Bonn

    Bonn, 53105

  • Dermatologikum Hamburg - Dept. of Allergology

    Hamburg, 20354

  • HNO Praxis Dr. Horn/Dr. Zeuner

    Heidelberg, 69120

  • Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin

    Hessen, 60590

  • Dres.Ina Röhrig-Petering und Holger Petering

    Hildesheim, 31134

  • FÄ HNO Allergologie

    Saalfeld, 07318

  • Klinikum Stuttgart - Klinik f. Dermatologie u. Allergologie

    Stuttgart, 70174

  • Universitäts- Hautklinik Eberhard Karls - Universität Tübingen Department of Dermatology

    Tübingen, 72076

  • Dr. Med. Ulrich Neumann

    Wolmirstedt, 393 26

Other trials in Germany

About this study

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

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.

Being tested
SUBLIVAC FIX phleum prat., Placebo
Keywords
Sublingual immunotherapy, Dose range finding, Dose tolerability, grass pollen, Allergic rhinitis/rhinoconjunctivitis, Safety, Immunogenicity
Medical subject headings
Rhinitis, Allergic

What participants receive

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

  • SUBLIVAC FIX phleum prat.Biological

    Comparison of different dosages to placebo

  • PlaceboBiological

Study groups in NCT01682070
Study groupRoleWhat they receive
SUBLIVAC FIX Phleum prat. 0 AUN/mlPlacebo comparatorNot described
Receives: Biological: Placebo
SUBLIVAC FIX Phleum prat. 3,333 AUN/mlExperimentalNot described
Receives: Biological: SUBLIVAC FIX phleum prat.
SUBLIVAC FIX phleum prat. 10,000 AUN/mlExperimentalNot described
Receives: Biological: SUBLIVAC FIX phleum prat.
SUBLIVAC FIX phleum prat. 20,000 AUN/mlExperimentalEvaluation of the SUBLIVAC FIX Phleum prat. 20,000 AUN/ml by an independent safety committee
Receives: Biological: SUBLIVAC FIX phleum prat.
SUBLIVAC FIX Phleum prat. 40,000 AUN/mlExperimentalStart 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
Receives: Biological: SUBLIVAC FIX phleum prat.

What is being measured

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

  1. Nasal Provocation Test (NPT)

    Measured: 5 months

  2. Number of related AEs

    Measured: First ten days of study medication intake

Secondary outcomes (3)

  1. Serum specific immunoglobulin levels (IgE, IgG, IgG4)

    Measured: 5 months

  2. Number of local and systemic reactions

    Measured: Duration of study medication intake (approximately 5 months)

  3. Peak Nasal Inspiratory Flow (PNIF)

    Measured: 5 months

Timeline

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

  1. First posted10 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionMay 2013
  4. Study completionMay 2013

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
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01682070
Sponsor's protocol ID
SP/0036
Status last verified
May 2013
First submitted
6 Sep 2012
Last updated
29 May 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SUBLIVAC FIX phleum prat. in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by HAL Allergy at 23 sites in 2 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 7 inclusion and 21 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 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Poland, Germany. 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. Some participants in this study may receive a placebo. 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?

Nasal Provocation Test (NPT) (time frame: 5 months). The study lists 2 primary outcomes in all. 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 NCT01682070.

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 29 May 2013.

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SUBLIVAC FIX Phleum Pratense DT/DRF (NCT01682070) | AzTrials