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

Sponsor
BioTech Tools S.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT01308021
Collaborator
(none)
202
Enrollment
19
Locations
3
Arms
12
Duration (Months)
10.6
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: gpASIT+TM
  • Biological: gpASIT+TM
  • Biological: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
202 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
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
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: gpASIT400

gpASIT+TM 400 µg

Biological: gpASIT+TM
entero-coated capsules containing 400µg of gpASIT+TM, daily , 28 days
Experimental: gpASIT800

gpASIT+TM 800 µg

Biological: gpASIT+TM
entero-coated capsules containing 800 µg of gpASIT+TM, daily, 28 days
Placebo Comparator: Placebo

Biological: Placebo
Placebo entero-coated capsules

Outcome Measures

Primary Outcome Measures

  1. Impact of gpASIT+TM on the clinical efficacy of the subjects [grass pollen season 2011 (April to July)]

    The following parameter will be assessed: rhinoconjunctivitis total symptom score

Secondary Outcome Measures

  1. Clinical tolerability and safety of the treatment [8 months]

    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)

  2. Impact of gpASIT+TM on the immunological status of the subjects [screening visit (January-February 2011), before pollen season (April 2011), during pollen season (June 2011) and after pollen season (August 2011)]

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

  3. Impact of gpASIT+TM on the clinical status of the subjects [grass pollen season 2011 (April-July)]

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

  4. Impact of gpASIT+TM on the quality of life of the subjects [grass pollen season 2011 (April-July)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHR Saint Joseph Warquignies Boussu Belgium 7300
2 AZ Sint Lucas Brugge Belgium 8310
3 Clinique du Parc Léopold Brussels Belgium 1040
4 UZ Brussel Brussels Belgium 1090
5 UCL Saint Luc Brussels Belgium 1200
6 UZ Antwerpen Edegem Belgium 2650
7 UZ Gent Gent Belgium 9000
8 UZ Leuven Leuven Belgium 3000
9 CHR Citadelle Liège Belgium 4000
10 CHU Sart-Tilman Liège Belgium 4000
11 CHU Ambroise Paré Mons Belgium 7000
12 UCL Mont Godinne Yvoir Belgium 5530
13 Hôpital Saint Vincent de Paul Lille France 59020
14 CHRU Lille Lille France 59037
15 Private practice Nantes France 44000
16 Private practice Nantes France 44400
17 CHU Reims Reims France 51100
18 CHRU Strasbourg Strasbourg France 67091
19 CH Luxembourg Luxembourg Luxembourg 1210

Sponsors and Collaborators

  • BioTech Tools S.A.

Investigators

  • Principal Investigator: Claus Bachert, MD, UZ Ghent
  • Principal Investigator: Jan Ceuppens, MD, UZ Leuven
  • Principal Investigator: Didier Ebo, MD, UZ Antwerpen
  • Principal Investigator: Jean-Luc Halloy, MD, CHR Warquignies
  • Principal Investigator: Stijn Hallewyck, MD, Universitair Ziekenhuis Brussel
  • Principal Investigator: Peter Hellings, MD, UZ Leuven
  • Principal Investigator: Renaud Louis, MD, Centre Hospitalier Universitaire de Liege
  • Principal Investigator: Catherine Mbasoa, MD, Clinique du Parc Léopold Bruxelles
  • Principal Investigator: Charles Pilette, MD, UCL Saint Luc Bruxelles
  • Principal Investigator: Hélène Simonis, MD, CHR Citadelle Liège
  • Principal Investigator: Olivier Vandenplas, MD, UCL Mont Godinne Yvoir
  • Principal Investigator: Christoph Verhoye, MD, AZ Sint-Lucas Brugge
  • Principal Investigator: Patricia Wackenier, MD, CHU Ambroise-Paré - Mons
  • Principal Investigator: Frédéric De Blay, MD, CHRU Strasbourg
  • Principal Investigator: Marie-Christine Castelain, MD, Hôpital Saint Vincent de Paul Lille
  • Principal Investigator: François Lavaud, MD, CHRU Reims
  • Principal Investigator: Benoît Wallaert, MD, CHU Lille
  • Principal Investigator: François Wessel, MD, Private Practice Nantes
  • Principal Investigator: Bruno Lebeaupin, MD, Private Practice Nantes
  • Principal Investigator: François Hentges, MD, CHL Luxembourg
  • Principal Investigator: François Durand Perdriel, MD, Private Practice Nantes
  • Principal Investigator: François Spirlet, MD, CH de Dinant

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BioTech Tools S.A.
ClinicalTrials.gov Identifier:
NCT01308021
Other Study ID Numbers:
  • BTT-gpASIT005
First Posted:
Mar 3, 2011
Last Update Posted:
May 26, 2014
Last Verified:
May 1, 2014
Keywords provided by BioTech Tools S.A.
Rhinoconjunctivitis
Allergy
Grass pollen
Hypersensitivity
Immune system disorder
Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal

Study Results

No Results Posted as of May 26, 2014