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Grass Pollen AllergyPhase 2NCT01308021

Clinical Efficacy and Safety of gpASIT+TM to Treat Seasonal Allergic Rhinoconjunctivitis

A Phase 2 study testing gpASIT+TM in people with Grass Pollen Allergy and Hay Fever, run by BioTech Tools S.A. at 19 sites in 3 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 purpose of the study is to evaluate the efficacy and safety of grass pollen-derived peptides administrated orally to treat seasonal allergic rhinoconjunctivitis. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Grass Pollen Allergy, Hay Fever
What is being tested?
gpASIT+TM
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
202 participants
Where
19 sitesin 3 countries
Study dates
Dec 2010to Dec 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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age between 18 and 50 years
  • Subject has given written informed consent
  • The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
  • Male or non pregnant, non-lactating female
  • Female unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period))
  • Allergy > 2 years

Who cannot join

  • Subjects with current immunotherapy or subjects who underwent a previous immunotherapy within the last 2 years
  • Subjects with perennial asthma
  • Subjects with a VC < 80% and FEV1 < 70%
  • Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
  • Documented evidence of chronic sinusitis (as determined by investigator)
  • Subjects with a history of hepatic or renal disease
Show all 26Show fewer
  • Subjects symptomatic to perennial inhalant allergens
  • Subject with malignant disease, autoimmune disease
  • Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD, ...)
  • Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc…)
  • Subjects requiring beta-blockers medication
  • Chronic use of concomitant medications that would affect assessment of the effectiveness of the trial medication (e.g. tricyclic antidepressants)
  • Subject with febrile illness (> 37.5°C, oral)
  • A known positive serology for HIV-1/2, HBV or HCV
  • The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry
  • Receipt of blood or a blood derivative in the past 6 months preceding trial entry
  • Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial
  • Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial
  • Use of long-acting antihistamines
  • Any condition which could be incompatible with protocol understanding and compliance
  • Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship
  • Unreliable subjects including non-compliant subjects, subjects with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as subjects unwilling to give informed consent or to abide by the requirements of the protocol
  • Participation in another clinical trial and/or treatment with an experimental drug within the last 2 years
  • A history of hypersensitivity to the excipients
  • Rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…)
  • Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator

Trial locations and contacts

19 sites in 3 countries.

19 sites in 3 countries

Belgium12 sites

  • CHR Saint Joseph Warquignies

    Boussu, 7300

  • AZ Sint Lucas

    Bruges, 8310

  • Clinique du Parc Léopold

    Brussels, 1040

  • UZ Brussel

    Brussels, 1090

  • UCL Saint Luc

    Brussels, 1200

  • UZ Antwerpen

    Edegem, 2650

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • CHR Citadelle

    Liège, 4000

  • CHU Sart-Tilman

    Liège, 4000

  • CHU Ambroise Paré

    Mons, 7000

  • UCL Mont Godinne

    Yvoir, 5530

Other trials in Belgium

France6 sites

  • Hôpital Saint Vincent de Paul

    Lille, 59020

  • CHRU Lille

    Lille, 59037

  • Private practice

    Nantes, 44000

  • Private practice

    Nantes, 44400

  • CHU Reims

    Reims, 51100

  • CHRU Strasbourg

    Strasbourg, 67091

Other trials in France

Luxembourg1 site

  • CH Luxembourg

    Luxembourg, 1210

Other trials in Luxembourg

About this study

Official title: Clinical Efficacy, Immunogenicity, Clinical Tolerability and Assessment of Safety of gpASIT+TM Administered Orally, According to Two Administration Schedules, for the Prophylaxis of Seasonal Grass Pollen Rhinoconjunctivitis

The purpose of the study is to evaluate the efficacy and safety of grass pollen-derived peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.

Being tested
gpASIT+TM, Placebo
Keywords
Rhinoconjunctivitis, Allergy, Grass pollen, Hypersensitivity, Immune system disorder
Medical subject headings
Rhinitis, Allergic, Seasonal, Hypersensitivity, Immune System Diseases

What participants receive

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

  • gpASIT+TMBiological

    entero-coated capsules containing 400µg of gpASIT+TM, daily , 28 days

  • gpASIT+TMBiological

    entero-coated capsules containing 800 µg of gpASIT+TM, daily, 28 days

  • PlaceboBiological

    Placebo entero-coated capsules

Study groups in NCT01308021
Study groupRoleWhat they receive
gpASIT400ExperimentalgpASIT+TM 400 µg
Receives: Biological: gpASIT+TM
gpASIT800ExperimentalgpASIT+TM 800 µg
Receives: Biological: gpASIT+TM
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo

What is being measured

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

  1. Impact of gpASIT+TM on the clinical efficacy of the subjects

    The following parameter will be assessed: rhinoconjunctivitis total symptom score

    Measured: grass pollen season 2011 (April to July)

Secondary outcomes (4)

  1. Clinical tolerability and safety of the treatment

    The following parameters will be assessed: general physical status, vital signs, haematological parameters, general blodd biochemistry parameters, all (serious) adverse events, immunological analysis (total IgG, IgE) and inflammatory parameters (CRP, sedimentation rate)

    Measured: 8 months

  2. Impact of gpASIT+TM on the immunological status of the subjects

    The following parameter will be assessed: allergen-specific immunoglobulin concentrations

    Measured: screening visit (January-February 2011), before pollen season (April 2011), during pollen season (June 2011) and after pollen season (August 2011)

  3. Impact of gpASIT+TM on the clinical status of the subjects

    The average daily symptom and rescue medication scores will be assessed.

    Measured: grass pollen season 2011 (April-July)

  4. Impact of gpASIT+TM on the quality of life of the subjects

    The quality of life will be assessed by the use of validated questionnaires.

    Measured: grass pollen season 2011 (April-July)

Timeline

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

  1. First posted3 Mar 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionOct 2011
  4. Study completionDec 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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01308021
Sponsor's protocol ID
BTT-gpASIT005
Status last verified
May 2014
First submitted
28 Feb 2011
Last updated
26 May 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gpASIT+TM in people with Grass Pollen Allergy and Hay Fever, run by BioTech Tools S.A. at 19 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 6 inclusion and 26 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 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Belgium, France, Luxembourg. 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?

Impact of gpASIT+TM on the clinical efficacy of the subjects (time frame: grass pollen season 2011 (April to July)). 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 NCT01308021.

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 26 May 2014.

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