EUCTR2013-005130-38-DE
Active, Not Recruiting
N/A
Evaluation of the efficacy and safety of AVANZ® Phleum pratense in grass pollen-induced allergic rhinitis during controlled exposure in an environmental challenge chamber
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Seasonal grass pollen induced allergic rhino-conjunctivitis with or without asthma.
- Sponsor
- ALK-Abello A/S
- Status
- Active, Not Recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A documented clinically relevant history of moderate\-to\-severe grass pollen induced rhinoconjunctivitis with or without asthma despite having received treatment with symptom relieving medication during the previous two grass pollen seasons
- •Positive SPT response (wheal diameter \= 3 mm) to Phleum pratense at screening
- •Positive specific IgE against Phleum pratense (\= IgE Class 2; \=0\.70 kU/L) at screening
- •Minimum level of rhinitis symptoms in an grass pollen challenge, defined as a TNSS of at least 6 (of 12\) within the 3\-hour grass pollen challenge at performed at the baseline ECC visit
- •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 130
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Rhinoconjunctivitis caused by ragweed, mugwort or Alternaria alternate, . Subjects sentised to ragweed, mugwort or Alternaria alternate are not eligible for the trial if they have symptoms induced by these allergens
- •Rhinoconjunctivitis caused by animal hair and dander to which the subject is regularly exposed. Subjects sensitised to perennial allergens such as house dust mites, and moulds are not eligible for the trial if they have symptoms induced by these allergens
- •Clinical history of uncontrolled asthma within 3 months prior to screening
- •Subjects with reduced lung function FEV1 \<70% of the predicted value after adequate pharmacologic treatment
- •Subjects with asthma requiring treatment with inhaled corticosteroids outside the grass pollen seasons
- •Previous treatment with immunotherapy to a grass pollen allergen or a cross\-reacting allergen within the past 5 years
Outcomes
Primary Outcomes
Not specified
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