Clinical trial NCT01902992: Efficacy and Safety of Intraseasonal Specific Immunotherapy With Depiquick® Birch
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Intraseasonal Specific Short-term Immunotherapy With Depigmented Glutaraldehyde Polymerized Birch Pollen Allergenic Extract (Depiquick® Birch) in Patients With Allergic Rhinitis and/or Rhinoconjunctivitis With or Without Intermittent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinoconjunctivitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-07-19
Enrollment: 202
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess efficacy and safety of intraseasonal specific short-term immunotherapy with Depiquick® Birch in patients with allergic rhinitis and or rhinoconjunctivitis with or without intermittent asthma that have a clinical relevant IgE-mediated allergic sensitization against birch pollen. The term "intraseasonal" means that patients will start with immunotherapy treatment during the birch pollen season, i.e. when the already experience allergic symptoms.


Eligibility criteria: Inclusion criteria:

1. Patients must experience significant allergic symptoms on visit 2
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:

1. History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens
2. FEV1 or PEF value ≤ 80 %
3. Persistent asthma (GINA ≥ 2)

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Combined Symptom and Medication Score (SMS)
timeFrame: From the start of treatment until the end of the relevant pollen exposition time.
Secondary outcomes:
measure: Combined Symptom and Medication Score (SMS)
timeFrame: date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months
measure: Onset of action (patient's assessment)
timeFrame: date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months
measure: Rhinoconjunctivitis Quality of Life questionnaire (RQLQ)
timeFrame: Visits 2, 4, 6, and 7
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Aschaffenburg
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Bad Wildbad
country: Germany
facility: Novartis Investigative Site
city: Bad Woerishofen
country: Germany
facility: Novartis Investigative Site
city: Bensheim
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Delitzsch
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Duelmen
country: Germany
facility: Novartis Investigative Site
city: Duisburg
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Gera
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Luebeck
country: Germany
facility: Novartis Investigative Site
city: Lübeck
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Neunkirchen
country: Germany
facility: Novartis Investigative Site
city: Nidderau
country: Germany
facility: Novartis Investigative Site
city: Oberhausen
country: Germany
facility: Novartis Investigative Site
city: Osnabrück
country: Germany
facility: Novartis Investigative Site
city: Rodgau
country: Germany
facility: Novartis Investigative Site
city: Wallenhorst
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Witten
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: