SUBLIVAC FIX Phleum Pratense DT/DRF

Launched by HAL ALLERGY · Sep 7, 2012

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ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent
• • Age ≥ 18 ≤ 60 years
• • Allergic rhinitis/rhinoconjunctivitis related to grass pollen with or without concomitant mild to moderate persistent asthma
• • FEV1 \> 70% for patients with a history of asthma, FEV \> 70% or PEF \> 80% for patients without a history of asthma
• • A positive SPT (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for grass pollen assessed within 1 year before randomization.
• • Positive serum specific anti-grass IgE-test (\> 0.7 U/mL)
• • A positive TNPT for grass pollen at screening (Lebel score ≥ 6) at ≤10,000 AU/mL
• Exclusion Criteria:
• • Patients with (expected) clinically relevant symptoms during the course of the trial due to concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3mm) to allergens other than grass pollen
• • Patients sensitized to pets should not be included if they are regularly exposed to pets and are symptomatic upon exposure to pets
• • Completed immunotherapy (SCIT or SLIT) with grass pollen allergens within the past 5 years
• • Completed unsuccessful specific immunotherapy in the past
• • Vaccination within one week before start of therapy or during the initiation phase
• • Anti-IgE therapy within the 6 months prior to inclusion and during the study
• • Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
• • Active malignancies or any malignant disease during the previous 5 years
• • Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or haematological disorders
• • Active inflammation or infection of the target organs (nose, eyes or lower airways) at the start of the study
• • Moderate to severe nasal obstructive diseases that preclude a TNPT (septal deviation, nasal polyps, recent nasal surgery, etc.)
• • Diseases with a contraindication for the use of Adrenaline (e.g. hyperthyroidism, glaucoma)
• • Use of systemic steroids within 4 weeks before start of the study and during the study
• • Treatment with systemic and local β-blockers
• • Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study
• • Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age (adequate contraceptive measures will be the use of a contraceptive device or -pill)
• • Alcohol, drug or medication abuse within the past year
• • Any clinically significant abnormal laboratory parameter at screening
• • Lack of cooperation or compliance
• • Severe psychiatric, psychological, or neurological disorders
• • Patients who are employees of the institution or 1st grade relatives or partners of the investigator