Twin SUBLIVAC® Grasses Clinical Efficacy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00422149
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : February 7, 2012
Information provided by:
HAL Allergy

Brief Summary:
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 or disease Intervention/treatment Phase
Rhinitis, Allergic, Seasonal Conjunctivitis, Allergic Drug: SUBLIVAC® Grasses/Placebo treatment Drug: SUBLIVAC® Grasses treatment Drug: Placebo treatment Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Twin SUBLIVAC® Grasses Clinical Efficacy Study
Study Start Date : September 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group. [ Time Frame: June, July, August 2007 ]

Secondary Outcome Measures :
  1. CIS derived variables [ Time Frame: June, July and August 2007 ]
  2. RQLQ, quantitative skin prick test [ Time Frame: Pollen season 2006 and 2007 ]
  3. oral allergy syndrome [ Time Frame: October 2006 until September 2007 ]
  4. mast-cell serum tryptase [ Time Frame: 6 months therapy ]
  5. specific immunoglobulins (IgE and IgG). [ Time Frame: 6 months therapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00422149

  Show 60 Study Locations
Sponsors and Collaborators
HAL Allergy
Principal Investigator: R Peter, Zentrum für Klinische Forschung, Helholzstrasse 8/1, 89081 Ulm, Germany

Responsible Party: H.A.J. Kleinjans, HAL Allergy BV Identifier: NCT00422149     History of Changes
Other Study ID Numbers: SG/0021
EudraCTnr: 2005-005175-16
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 2012

Keywords provided by HAL Allergy:
Sublingual immunotherapy

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