Safety and Tolerance Study of Grass Pollen-Derived Peptides to Treat Allergic Rhinitis

This study has been completed.

Sponsor:

Information provided by:

BioTech Tools S.A.

ClinicalTrials.gov Identifier:

NCT00813046

First received: December 19, 2008

Last updated: January 30, 2009

Last verified: January 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	December 19, 2008
Last Updated Date	January 30, 2009
Start Date ^ICMJE	December 2008
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 19, 2008)	To demonstrate the clinical tolerability and safety of the treatment by looking at the absence of immediate allergic reaction. [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00813046 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 19, 2008)	vital signs clinical laboratory evaluations adverse events general physical status [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Tolerance Study of Grass Pollen-Derived Peptides to Treat Allergic Rhinitis
Official Title ^ICMJE	Preliminary Assessment of the Short Term Clinical Tolerability and Safety of Grass Pollen-Derived Peptides for Oral Use in Antigen-Specific Immunotherapy of Seasonal Allergic Rhinoconjunctivitis
Brief Summary	The purpose of this study is to determine whether the oral administration of grass pollen peptides to treat allergic rhinitis is safe and well tolerated.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Seasonal Allergic Rhinoconjunctivitis
Intervention ^ICMJE	Biological: gpASIT+TM oral administration of entero-coated capsules containing increasing doses of gpASIT+TM (25 to 1600µg), one dose per day for 4 days
Study Arm (s)	Experimental: gpASIT+TM Intervention: Biological: gpASIT+TM
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	8
Completion Date	January 2009
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 females A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the last two years A positive skin prick test 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 for SAR 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 food allergy and consecutive anaphylaxis Subjects with a history of hepatic or renal disease 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). Females unable to bear children must have documentation of such (i.e. tubal ligation, hysterectomy, or post menopausal [defined as a minimum of one year since the last menstrual period]) 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 with clinically relevant abnormal QTc intervals of the ECG : QTc > 450 ms for man and > 470 ms for women Subjects requiring beta-blockers medication Chronic use of concomitant medications that would affect assessment of the effectiveness of the study 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 study entry Receipt of blood or a blood derivative in the past 6 months preceding study entry Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the study, any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the study 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, Participation in another clinical trial and/or treatment with an experimental drug within 1 month of study start A history of hypersensitivity to the excipients
Gender	Both
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium

Administrative Information
NCT Number ^ICMJE	NCT00813046
Other Study ID Numbers ^ICMJE	BTT-gpASIT002, EudraCT 2008-006368-12
Has Data Monitoring Committee	Yes
Responsible Party	Thierry Legon, BioTech Tools
Study Sponsor ^ICMJE	BioTech Tools S.A.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	BioTech Tools S.A.
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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