Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

Artu Biologicals

Status and phase

Completed

Phase 3

Phase 2

Conditions

Allergic Rhinoconjunctivitis

Treatments

Drug: Oralgen

Drug: grass pollen extract

Study type

Interventional

Funder types

Industry

Identifiers

NCT00567346

2006-001548-30 (EudraCT Number)

AB0602

Details and patient eligibility

About

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.

Full description

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.

Enrollment

605 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

605 participants in 4 patient groups, including a placebo group

grass pollen extract twice weekly

Active Comparator group

Description:

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.

Treatment:

Drug: Oralgen

Grass pollen extract, daily

Active Comparator group

Description:

Grass pollen immunotherapy, 9,500 BU, given daily

Treatment:

Drug: Oralgen

Increased dose of grass pollen extract

Active Comparator group

Description:

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