Safety Study of Grass Pollen-derived Peptides to Treat Seasonal Allergic Rhinoconjunctivitis

Seasonal Allergic Rhinoconjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833066
• Other study ID #: BTT-gpASIT003
• Secondary ID: EudraCT 2008-006
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 29, 2009
• Last updated: November 16, 2011
• Start date: February 2009
• Est. completion date: November 2009

Study information

• Verified date: November 2011
• Source: BioTech Tools S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic
• Seasonal Allergic Rhinoconjunctivitis

Intervention

Biological:
• gpASIT+TM
entero-coated capsules containing 25µg of gpASIT+TM
• Placebo
placebo entero-coated capsules
• gpASIT+TM
entero-coated capsules containing 100µg of gpASIT+TM
• gpASIT+TM
entero-coated capsules containing 400µg of gpASIT+TM

Locations

Country	Name	City	State
Belgium	University Hospital Brugmann	Brussels
Belgium	University Hospital Ghent	Ghent
Belgium	University Hospital Gasthuisberg	Leuven
Belgium	University Hospital Sart Tilman	Liège

Sponsors (1)

Lead Sponsor	Collaborator
BioTech Tools S.A.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of allergic reaction		within the first 14 days (plus or minus 1 day)	Yes
Secondary	Immunological assessment		9 months	No
Secondary	Allergy symptom and medication scores		grass pollen season 2009	No