Efficacy and Safety of Intraseasonal Specific Immunotherapy With Depiquick® Birch
NCT ID: NCT01902992
Last Updated: 2017-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
202 participants
INTERVENTIONAL
2012-03-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Depiquick® Birch
At the screening visit (Visit 1), patients will be instructed how to complete the eDiary. Eligible patients will return for visit 2 as soon as they experience significant allergic symptoms. Significant allergic symptoms are defined by a symptom score ≥ 2. If the patients' eligibility has been confirmed according to inclusion/exclusion criteria checklist, randomization to one of the 2 treatment arms will be conducted. Patients will receive two consecutive subcutaneous injections of study medication (0,2 and 0,3 ml) with a time lag of ≥ 30 minutes. Patients return to the study site in weekly intervals for visit 3, visit 4, visit 5, visit 6, and visit 7 to receive study medication injections (0,5 ml each). If treatment is completed before the end of the tree pollen season, patients will be followed-up by telephone calls every 4 weeks until the end of the tree pollen season. The study completion visit will take place 4 weeks after the end of the tree pollen season.
Depiquick Birch (DPG103)
Placebo
At the screening visit (Visit 1), patients will be instructed how to complete the eDiary. Eligible patients will return for visit 2 as soon as they experience significant allergic symptoms. Significant allergic symptoms are defined by a symptom score ≥ 2. If the patients' eligibility has been confirmed according to inclusion/exclusion criteria checklist, randomization to one of the 2 treatment arms will be conducted. Patients will receive two consecutive subcutaneous injections of study medication (0,2 and 0,3 ml) with a time lag of ≥ 30 minutes. Patients return to the study site in weekly intervals for visit 3, visit 4, visit 5, visit 6, and visit 7 to receive study medication injections (0,5 ml each). If treatment is completed before the end of the tree pollen season, patients will be followed-up by telephone calls every 4 weeks until the end of the tree pollen season. The study completion visit will take place 4 weeks after the end of the tree pollen season.
Placebo
Interventions
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Depiquick Birch (DPG103)
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Medical history of allergic rhinitis and/or rhinoconjunctivitis with clinically relevant sensitization to tree allergens
3. Specific IgE against birch allergens (CAP RAST ≥ 2)
Exclusion Criteria
2. FEV1 or PEF value ≤ 80 %
3. Persistent asthma (GINA ≥ 2)
12 Years
70 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Aachen, , Germany
Novartis Investigative Site
Aschaffenburg, , Germany
Novartis Investigative Site
Augsburg, , Germany
Novartis Investigative Site
Bad Wildbad, , Germany
Novartis Investigative Site
Bad Wörishofen, , Germany
Novartis Investigative Site
Bensheim, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Bochum, , Germany
Novartis Investigative Site
Bonn, , Germany
Novartis Investigative Site
Chemnitz, , Germany
Novartis Investigative Site
Delitzsch, , Germany
Novartis Investigative Site
Dresden, , Germany
Novartis Investigative Site
Duisburg, , Germany
Novartis Investigative Site
Dülmen, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Gera, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Lübeck, , Germany
Novartis Investigative Site
Münster, , Germany
Novartis Investigative Site
Münster, , Germany
Novartis Investigative Site
Neunkirchen, , Germany
Novartis Investigative Site
Nidderau, , Germany
Novartis Investigative Site
Oberhausen, , Germany
Novartis Investigative Site
Osnabrück, , Germany
Novartis Investigative Site
Rodgau, , Germany
Novartis Investigative Site
Wallenhorst, , Germany
Novartis Investigative Site
Wiesbaden, , Germany
Novartis Investigative Site
Wiesbaden, , Germany
Novartis Investigative Site
Witten, , Germany
Countries
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Other Identifiers
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2011-004185-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CDPG103ADE01
Identifier Type: -
Identifier Source: org_study_id
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