Trial | NCT00567346  Report issue

Title

Efficacy and Safety of Grass Pollen Sublingual Immunotherapy
A Randomised, DB, Plcb Controlled, Multicentre, Multinational Phase II/III Study to Assess the Efficacy and Safety of Three Different Dose Regimens of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    605
The study is assessing efficacy and safety of three different dosage regimens of grass pollen sublingual immunotherapy in adult patients suffering from grass pollen related rhinoconjunctivitis.
Patients with seasonal grass pollen related rhinoconjunctivitis will be randomized to one of four treatment groups at 41 centres in Europe. Each treatment group will consist of approximately 150 patients and 150 patients will be randomized to a placebo group. The study will consist of a screening phase, a treatment phase and a variable maintenance period.
Study Started
Dec 31
2006
Primary Completion
Oct 31
2007
Study Completion
Mar 31
2008
Last Update
May 05
2010
Estimate

Drug Oralgen

Patients will receive drops of grass pollen immunotherapy sublingually

  • Other names: grass pollen extract

Drug grass pollen extract

Patients will receive matching placebo sublingually

  • Other names: Placebo control

grass pollen extract twice weekly Active Comparator

Current standard dose regimen of grass pollen immunotherapy (9,500 BU), given twice weekly. Note: patients in twice weekly dosing regimen will also receive placebo on days no active treatment is given.

Grass pollen extract, daily Active Comparator

Grass pollen immunotherapy, 9,500 BU, given daily

Increased dose of grass pollen extract Active Comparator

Increased dose of grass pollen immunotherapy, 19,000 BU, given daily

Placebo control Placebo Comparator

Patients randomized to placebo will receive placebo daily.

Criteria 

Inclusion Criteria:

male or female aged 18-50
patients with grass pollen related allergic rhinoconjunctivitis for at least 2 pollen seasons
Positive skin prick test and IgE value of at least Class 2+
RTSS of greater or equal to 14 during pollen season prior tot the start of the study
Patients must be in general good health
Patients with normal spirometry
Informed consent given and willing to comply with the protocol
Female patients are eligible if they use an accepted contraceptive method
Negative urine pregnancy test if female

Exclusion Criteria:

Pregnancy, breast feeding
Asthma requiring treatment other than beta-2 inhaled agonists
patients who have taken oral steroids within 12 weeks before screening visit
patients who have received desensitisation treatment for grass pollen
treatment by immunotherapy with any other allergen within the previous 5 years
patients who have suffered a lower respiratory tract infection within 4 weeks or an upper respiratory tract infection within 2 weeks of the screening visit
patients at risk of non-compliance
participation in any other clinical study within the previous 3 months
patients with a past or current disease, which may affect participation in or outcome of this study.
patients treated with beta-blockers or under continuous corticotherapy
allergic sensitivity to epithelial allergens the patients is exposed to
positive skin prick test for environmental allergens and suffering from serious allergic symptoms due to exposure to these allergens during study period
intention to subject the patient to surgery of the nasal cavity during current study
Usual contraindications of immunotherapy
a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of, and potentially overlapping the grass pollen season
No Results Posted