NCT00833066

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 17, 2011

Status Verified

November 1, 2011

Enrollment Period

8 months

First QC Date

January 29, 2009

Last Update Submit

November 16, 2011

Conditions

Seasonal Allergic Rhinoconjunctivitis

Keywords

hay fevergrass pollen allergy

Outcome Measures

Primary Outcomes (1)

  • Evidence of allergic reaction

    within the first 14 days (plus or minus 1 day)

Secondary Outcomes (2)

  • Immunological assessment

    9 months

  • Allergy symptom and medication scores

    grass pollen season 2009

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Biological: Placebo

gpASIT 25

EXPERIMENTAL
Biological: gpASIT+TM

gpASIT 100

EXPERIMENTAL
Biological: gpASIT+TM

gpASIT 400

EXPERIMENTAL
Biological: gpASIT+TM

Interventions

gpASIT+TMBIOLOGICAL

entero-coated capsules containing 25µg of gpASIT+TM

gpASIT 25
PlaceboBIOLOGICAL

placebo entero-coated capsules

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital Brugmann

Brussels, 1020, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

University Hospital Gasthuisberg

Leuven, 3000, Belgium

Location

University Hospital Sart Tilman

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

February 1, 2009

Primary Completion

October 1, 2009

Study Completion

November 1, 2009

Last Updated

November 17, 2011

Record last verified: 2011-11

Locations

BE(4)