Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of 300 IR Sublingual Immunotherapy Tablets

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

633 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen rhinoconjunctivitis

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis

NCT00803244

Primary Disease

COMPLETED PHASE3

Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis

NCT00367640

Allergy

COMPLETED PHASE2/PHASE3

Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis

NCT00409409

Allergy

COMPLETED PHASE3

Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis

NCT00955825

Allergic Rhinitis Due to Grass Pollens

COMPLETED PHASE3

Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract

NCT00619827

Seasonal Allergic Rhinitis

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allergy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

300 IR (4M)

300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season

Group Type EXPERIMENTAL

300 IR (4M)

Intervention Type DRUG

300 IR grass pollen allergen extract tablet starting 4 months before the pollen season

300 IR (2M)

300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season

Group Type EXPERIMENTAL

300 IR (2M)

Intervention Type DRUG

300 IR grass pollen allergen extract tablet starting 2 months before the pollen season

Placebo

Placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

300 IR (4M)

300 IR grass pollen allergen extract tablet starting 4 months before the pollen season

Intervention Type DRUG

300 IR (2M)

300 IR grass pollen allergen extract tablet starting 2 months before the pollen season

Intervention Type DRUG

Placebo

Placebo tablet

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sublingual immunotherapy tablet Sublingual immunotherapy tablet Sublingual placebo tablet

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female outpatients aged 18 to 50 years
* Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons
* Positive SPT and specific IgE values of at least Class 2 for grass pollen allergens
* A score of greater than or equal to 12 out of a possible 18 on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS)

Exclusion Criteria

* Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to sensitisation to allergens other than grass pollen must 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 any desensitisation treatment for grass pollen or with any other allergen within the previous 5 years.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No