A Randomised, Double-blind, Placebo Controlled Study With Oralgen Grass Pollen Rhinoconjunctivitis

A Randomised Double Blind Placebo-controlled, Long-term Phase III Study to Assess the Efficacy and Safety of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00812799

Enrollment

374

Registered

2008-12-22

Start date

2008-12-31

Completion date

2011-12-31

Last updated

2010-04-30

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

Conditions

Allergic Rhinoconjunctivitis

Keywords

randomised, double-blind, placebo-controlled, efficacy and safety, Oralgen® Grass Pollen, allergic rhinoconjunctivitis, allergy, rhinoconjunctivitis, immunotherapy, grass pollen extract

Brief summary

This study will be performed to determine the long-term efficacy of 19.000 BU Oralgen grass pollen administered daily in patients with grass pollen related allergic rhinoconjunctivitis.

Detailed description

Patients between 18 and 60 years will be randomized to receive either Oralgen grass pollen or placebo administered sublingually once a day. Treatment will start at least 16 weeks prior to the anticipated start of the pollen season 2009 and will last until the end of the pollen season 2011. Study medication will be titrated during the first period of treatment until maintenance dose has been reached.

Interventions

DRUGOralgen

19.000 BU daily

OTHERplacebo control

placebo control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* male or female * grass pollen related rhinoconjunctivitis symptoms for at least the last 2 pollen seasons * positive skin prick test RRTSS greater or equal to 12 during the 2008 season * signed informed consent

Exclusion criteria

* positive skin prick test for other environmental allergens and suffering from serious allergic symptoms * clinical history of significant symptomatic allergic rhinitis due to tree/weed pollen which potentially overlap the grass pollen season * clinical history of symptomatic perennial allergic rhinitis caused by an allergen to which the patient is regularly exposed * lacking of good health * abnormal spirometry * lower respiratory tract infection * asthma requiring treatment other than beta-2 agonists * oral steroids within 12 weeks before screening * regular contraindications for use of immunotherapy

Design outcomes

Primary

Measure	Time frame
Difference between active and placebo-group based on combined RTSS and RMS score	third season

Secondary

Measure	Time frame
Difference between active and placebo based on RTSS score	third season

Countries

Belgium, France, Germany, Netherlands, Poland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026