Twin SUBLIVAC® Grasses Clinical Efficacy Study

This study has been completed.
Sponsor:
Information provided by:
HAL Allergy
ClinicalTrials.gov Identifier:
NCT00422149
First received: January 12, 2007
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

To show that treatment with SUBLIVAC® Grasses is clinically effective by means of reduction in allergic symptoms and/or use of allergic symptomatic medication in subjects suffering from IgE mediated allergic complaints triggered by grass pollen.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Conjunctivitis, Allergic
Drug: SUBLIVAC® Grasses/Placebo treatment
Drug: SUBLIVAC® Grasses treatment
Drug: Placebo treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Twin SUBLIVAC® Grasses Clinical Efficacy Study

Resource links provided by NLM:


Further study details as provided by HAL Allergy:

Primary Outcome Measures:
  • Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group. [ Time Frame: June, July, August 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CIS derived variables [ Time Frame: June, July and August 2007 ] [ Designated as safety issue: No ]
  • RQLQ, quantitative skin prick test [ Time Frame: Pollen season 2006 and 2007 ] [ Designated as safety issue: No ]
  • oral allergy syndrome [ Time Frame: October 2006 until September 2007 ] [ Designated as safety issue: No ]
  • mast-cell serum tryptase [ Time Frame: 6 months therapy ] [ Designated as safety issue: No ]
  • specific immunoglobulins (IgE and IgG). [ Time Frame: 6 months therapy ] [ Designated as safety issue: No ]

Enrollment: 350
Study Start Date: September 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
SUBLIVAC® Grasses treatment
Drug: SUBLIVAC® Grasses/Placebo treatment
SUBLIVAC® Grasses/Placebo treatment
Drug: SUBLIVAC® Grasses treatment
SUBLIVAC® Grasses treatment
Placebo Comparator: 2
Placebo treatment
Drug: SUBLIVAC® Grasses/Placebo treatment
SUBLIVAC® Grasses/Placebo treatment
Drug: Placebo treatment
Placebo treatment

Detailed Description:

Indication under study: IgE mediated allergic disorders triggered by grass pollen.

Number of centres: approximately 50.

Study period planned: Q2-2006 until Q3-2008 Analysis after one exposed season (2007); based on the outcome the study will be stopped or continued for another season.

Subject selection criteria: Seasonal rhinitis and/or rhinoconjunctivitis with or without mild asthma (FEV1 > 70%) related to grass pollen, age 12 years or older.

Dosage schedule: Start with two drops daily of SUBLIVAC® and increase by two drops daily, until the maintenance dose of 10 drops SUBLIVAC® GrassesSUBLIVAC® Grasses is reached.

Route of administration: Sublingual application (drops are to be held underneath the tongue for 2-3 minutes and then will be swallowed).

Duration of treatment: 6 to 12 months blinded per subject . Efficacy parameters

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with allergic rhinoconjunctivitis with or without mild asthma FEV1 ≥ 70%) for at least 2 years. Their allergic symptoms should be related to grass pollen Use of anti-allergy symptomatic medication in the last pollen season (or, in case of a low pollen season, in one of the two previous years)
  • A positive skin prick test (>3 mm) for early flowering treesgrasses and specific serum IgE-test(>1 U/ml) for grass pollen (Lolium perenne, Phleum pratense and Poa pratensis).

Exclusion Criteria:

  • A positive SPT for perennial allergens of house dust mite
  • Allergy to any of the excipients
  • Symptoms related to concomitant sensitisation to perennial allergens of pets
  • Chronic asthma or emphysema, particularly with a FEV1 < 70 % of predicted value or use of inhalation corticosteroids outside grass and tree pollen season for more than two episodes and/or longer than fourteen days
  • Use of symptomatic medication for more than three episodes and/or longer than three days outside the tree- or grass pollen season
  • Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV)
  • Inflammation and infection of the target organ
  • Severe atopic dermatitis requiring systemic immuno-suppressive medication
  • Allergen specific immuno-therapy treatment within the last 5 years for a period longer than three months
  • History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis
  • A positive pregnancy test, lactation or inadequate contraceptive measures Alcohol- or drug abuse
  • Lack of co-operation or severe psychological disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422149

  Show 60 Study Locations
Sponsors and Collaborators
HAL Allergy
Investigators
Principal Investigator: R Peter, Prof.Dr.med Zentrum für Klinische Forschung, Helholzstrasse 8/1, 89081 Ulm, Germany
  More Information

No publications provided

Responsible Party: H.A.J. Kleinjans, HAL Allergy BV
ClinicalTrials.gov Identifier: NCT00422149     History of Changes
Other Study ID Numbers: SG/0021, EudraCTnr: 2005-005175-16
Study First Received: January 12, 2007
Last Updated: February 6, 2012
Health Authority: Germany: Paul-Ehrlich-Institut
Netherlands: Medical Ethics Review Committee (METC)
Poland: Ministry of Health
Belgium: Institutional Review Board

Keywords provided by HAL Allergy:
Sublingual immunotherapy
Rhinoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Rhinitis, Allergic, Seasonal
Rhinitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 17, 2014