Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Artu Biologicals

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