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

To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Written consent
Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons.
Sensitised to grass pollen (positive SPT and RAST level of at least class 2).
Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12.
Safety laboratory resuts within the references ranges

Exclusion criteria

Pregnancy, breast-feeding/lactation
Had received desensitisation treatment for grass pollen
Treatment by immunotherapy with another allergen within the previous 5 years
Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies
Treated with beta-blockers or under continuous corticotherapy

Treatment and study plan

100 IR grass pollen allergen extract tablet

Drug

One sublingual tablet daily during 4 months before pollen season and during pollen season

Other names: Sublingual immunotherapy tablet

300 IR grass pollen allergen extract tablet

Drug

One sublingual tablet daily during 4 months before pollen season and during pollen season

Other names: Sublingual immunotherapy tablet

500 IR grass pollen allergen extract tablet

Drug

One sublingual tablet daily during 4 months before pollen season and during pollen season

Other names: Sublingual immunotherapy tablet

Placebo Tablet

Drug

One sublingual tablet daily during 4 months before pollen season and during pollen season

Other names: Sublingual placebo tablet

Primary outcomes

Average Rhinoconjunctivitis Total Symptom Score

Time frame: Pollen period (average of 32 days in the ITT set)

Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment.

Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome.

Sponsors and collaborators

Lead sponsor

Stallergenes Greer

Industry

Registry information

Official study title

Randomised,Double-blind,Placebo-controlled,Multinational,Multi-centre,Phase IIb/III Study of the Efficacy and Safety of Three Doses of Sublingual Immunotherapy (SLIT) Administered as Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Aug 23, 2006
Registry last updated: May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed