Clinical trial NCT01308021: Clinical Efficacy and Safety of gpASIT+TM to Treat Seasonal Allergic Rhinoconjunctivitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Grass Pollen Allergy
Hay Fever
Keywords: Rhinoconjunctivitis
Allergy
Grass pollen
Hypersensitivity
Immune system disorder
Lead sponsor: BioTech Tools S.A.
Sponsor class: INDUSTRY
First posted: 2011-03-03
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Impact of gpASIT+TM on the clinical efficacy of the subjects
timeFrame: grass pollen season 2011 (April to July)
Secondary outcomes:
measure: Clinical tolerability and safety of the treatment
timeFrame: 8 months
measure: Impact of gpASIT+TM on the immunological status of the subjects
timeFrame: screening visit (January-February 2011), before pollen season (April 2011), during pollen season (June 2011) and after pollen season (August 2011)
measure: Impact of gpASIT+TM on the clinical status of the subjects
timeFrame: grass pollen season 2011 (April-July)
measure: Impact of gpASIT+TM on the quality of life of the subjects
timeFrame: grass pollen season 2011 (April-July)
Other outcomes:
Locations:
city: Boussu
country: Belgium
facility: CHR Saint Joseph Warquignies
city: Brugge
country: Belgium
facility: AZ Sint Lucas
city: Brussels
country: Belgium
facility: Clinique du Parc Léopold
city: Brussels
country: Belgium
facility: UZ Brussel
city: Brussels
country: Belgium
facility: UCL Saint Luc
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHR Citadelle
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Mons
country: Belgium
facility: CHU Ambroise Paré
city: Yvoir
country: Belgium
facility: UCL Mont Godinne
city: Lille
country: France
facility: Hôpital Saint Vincent de Paul
city: Lille
country: France
facility: CHRU Lille
city: Nantes
country: France
facility: Private practice
city: Nantes
country: France
facility: Private practice
city: Reims
country: France
facility: CHU Reims
city: Strasbourg
country: France
facility: CHRU Strasbourg
city: Luxembourg
country: Luxembourg
facility: CH Luxembourg
Study officials:
affiliation: UZ Ghent
name: Claus Bachert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Leuven
name: Jan Ceuppens, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Antwerpen
name: Didier Ebo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHR Warquignies
name: Jean-Luc Halloy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Stijn Hallewyck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Leuven
name: Peter Hellings, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Liege
name: Renaud Louis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique du Parc Léopold Bruxelles
name: Catherine Mbasoa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCL Saint Luc Bruxelles
name: Charles Pilette, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHR Citadelle Liège
name: Hélène Simonis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCL Mont Godinne Yvoir
name: Olivier Vandenplas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ Sint-Lucas Brugge
name: Christoph Verhoye, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Ambroise-Paré - Mons
name: Patricia Wackenier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Strasbourg
name: Frédéric De Blay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Saint Vincent de Paul, Lille
name: Marie-Christine Castelain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Reims
name: François Lavaud, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Lille
name: Benoît Wallaert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Practice Nantes
name: François Wessel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Practice Nantes
name: Bruno Lebeaupin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHL Luxembourg
name: François Hentges, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Practice Nantes
name: François Durand Perdriel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH de Dinant
name: François Spirlet, MD
role: PRINCIPAL_INVESTIGATOR
References: