An interventional trial assessing the tolerability and safety of GRAZAX® in adults with grass pollen allergy

• Conditions: Grass pollen induced rhinoconjunctivitis; MedDRA version: 12.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitis

• Registration Number: EUCTR2009-014522-41-DE
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-21
• Last Update Posted: 26 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients who meet each of the following criteria are eligible for the trial:
1.Written informed consent obtained before entering the trial
2.Willing and able to comply with the trial protocol regimen
3.Participated in the GT-08 extension trial and received placebo treatment
4.Will be prescribed Grazax in line with approved SmPC.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who meet one or more of the following criteria are excluded from the trial:
1.History of allergy, hypersensitivity or intolerance to any of the excipients (except Phleum pratense)
2.Malignancy or systemic diseases affecting the immune system e.g. autoimmune diseases, immune complex diseases or immune deficiency diseases
3.Alcohol or drug abuse
4. Immunosuppressive treatment
5. Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis
6.Uncontrolled or severe asthma (FEV1 < 70% of predicted value after adequate pharmacologic treatment)
7.Pregnancy
8. Conditions or diseases which are contraindicated or otherwise not in line with the approved Grazax SmPC
9.Simultaneously participating in a different trial including a treatment intervention and/or an investigational medicinal product (IMP).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to investigate the safety and tolerability of Grazax;Secondary Objective: to evaluate the patients’ satisfaction with Grazax;Primary end point(s): To investigate the safety and tolerability of Grazax