A randomised, double-blind, placebo-controlled, multi-national, multi-centre, Phase III study to assess the long term efficacy, carry-over effect and safety of two dosing regimens of 300 IR sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily to patients suffering from grass pollen rhinoconjunctivitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003258-98-CZ

Enrollment

780

Registered

2006-08-25

Start date

2007-04-11

Completion date

Unknown

Last updated

2013-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

grass pollen rhinoconjunctivitis MedDRA version: 8.1 Level: PT Classification code 10039085 Term: Rhinitis allergic

Interventions

Product Name: Allergen extract of grass pollen Product Code: SLIT Pharmaceutical Form: Sublingual tablet INN or Proposed INN: Allergen extract of grass pollen Other descriptive name: Extract of cocksf

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male or female outpatients aged 18 to 50 years (inclusive). • Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons. • Sensitised to grass pollen (positive skin prick test and IgE level of at least Class 2). • Total symptom score on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) during the previous pollen season of greater than or equal to 12 out of a possible score of 18. • Female patients of childbearing potential must be willing and able to sign written informed consent stating that they will use appropriate contraception and not plan a pregnancy for the first 3 years of this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to sensitisation to allergens other than grass pollen may not be included. Patients must be asymptomatic to all other allergens during the grass pollen season. Patients who have allergic rhinitis due to perennial allergen may not be included. • Asthma requiring treatment other than beta-2 inhaled agonists. • Patients who have received desensitisation treatment for grass pollen.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the sustained clinical effect and post-treatment long-term efficacy of SLIT for grass pollen allergens on: - The Average Adjusted Symptom Score (AASS): A score taking into account the daily Rhinoconjunctivitis Total Symptom Scores (RTSSs) and rescue medication use.;Secondary Objective: To assess the sustained clinical effect and post-treatment long-term efficacy of SLIT for grass pollen allergens on: The Average Rhinoconjunctivitis Total Symptom Score (ARTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes. The Average Rescue Medication Score (ARMS) and use of rescue medication (antihistamine [oral form or / and eye drops], nasal corticosteroid and oral corticosteroid). The Average Combined Score (ACS): A score taking into account the Rhinoconjunctivitis Total Symptom Score (RTSS) and Rescue Medication Score (RMS). Each of the six individual Average Rhinoconjunctivitis Symptom Scores (ARSS). The Overall Rhinoconjunctivitis Quality of Life Questionnaire Score (RQLQ). The proportion of symptom-controlled days (PSCD). The global evaluation of the efficacy of sublingual tablets of grass pollen allergen extract by the patient. To document the safety of the treatment.;Primary end point(s): The AASS while on treatment during the third pollen period is the primary efficacy endpoint for the sustained clinical effect, and the AASS during the fourth and fifth pollen periods is the endpoint for the assessment of the post-treatment long-term efficacy.	—

Measure

Time frame

Main Objective: To assess the sustained clinical effect and post-treatment long-term efficacy of SLIT for grass pollen allergens on: - The Average Adjusted Symptom Score (AASS): A score taking into account the daily Rhinoconjunctivitis Total Symptom Scores (RTSSs) and rescue medication use.;Secondary Objective: To assess the sustained clinical effect and post-treatment long-term efficacy of SLIT for grass pollen allergens on: The Average Rhinoconjunctivitis Total Symptom Score (ARTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes. The Average Rescue Medication Score (ARMS) and use of rescue medication (antihistamine [oral form or / and eye drops], nasal corticosteroid and oral corticosteroid). The Average Combined Score (ACS): A score taking into account the Rhinoconjunctivitis Total Symptom Score (RTSS) and Rescue Medication Score (RMS). Each of the six individual Average Rhinoconjunctivitis Symptom Scores (ARSS). The Overall Rhinoconjunctivitis Quality of Life Questionnaire Score (RQLQ). The proportion of symptom-controlled days (PSCD). The global evaluation of the efficacy of sublingual tablets of grass pollen allergen extract by the patient. To document the safety of the treatment.;Primary end point(s): The AASS while on treatment during the third pollen period is the primary efficacy endpoint for the sustained clinical effect, and the AASS during the fourth and fifth pollen periods is the endpoint for the assessment of the post-treatment long-term efficacy.

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Countries

Austria, Czech Republic, Denmark, France, Germany, Italy, Slovakia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026