Clinical trial NCT00833066: Safety Study of Grass Pollen-derived Peptides to Treat Seasonal Allergic Rhinoconjunctivitis
Official title: Preliminary Assessment of the Clinical Tolerability, Safety and Immunogenicity of Three Different Doses of Grass Pollen-derived Peptides for Oral Use in Antigen-specific Immunotherapy of Seasonal Allergic Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Seasonal Allergic Rhinoconjunctivitis
Keywords: hay fever
grass pollen allergy
Lead sponsor: BioTech Tools S.A.
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the oral administration of grass pollen peptides is safe and effective in the treatment of allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Subject has given written informed consent
* Age between 18 and 50 years
* 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:

A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the two previous years A positive skin prick test (wheal diameter \>= 3 mm) to grass-pollen mixture Specific IgE against grass pollen (RAST class 2 or IgE \> 0.7 kU/l) Asymptomatic to perennial inhalant allergens.

Exclusion Criteria:

* Subjects with current or past immunotherapy (any time in the past)
* Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
* Documented evidence of acute or significant chronic sinusitis (as determined by individual 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 or duodenal ulcer, 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, HBs antigen or anti-HCV antibodies
* 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 1 month of trial start
* 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
* Subjects who participated to trial BTT-gpASIT002

Primary outcomes:
measure: Evidence of allergic reaction
timeFrame: within the first 14 days (plus or minus 1 day)
Secondary outcomes:
measure: Immunological assessment
timeFrame: 9 months
measure: Allergy symptom and medication scores
timeFrame: grass pollen season 2009
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: University Hospital Brugmann
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
city: Liège
country: Belgium
facility: University Hospital Sart Tilman
Study officials:
References: