Efficacy and Safety of Intraseasonal Specific Immunotherapy With Depiquick® Birch

Allergic Rhinoconjunctivitis Clinical Trial

— INSIDE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902992
• Other study ID #: CDPG103ADE01
• Secondary ID: 2011-004185-14
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2011
• Last updated: March 20, 2017
• Start date: March 2012
• Est. completion date: July 2012

Study information

• Verified date: March 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Depiquick Birch (DPG103)

• Placebo

Locations

Country	Name	City	State
Germany	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 Woerishofen
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	Duelmen
Germany	Novartis Investigative Site	Duisburg
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Gera
Germany	Novartis Investigative Site	Hannover
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	Luebeck
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Muenster
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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined Symptom and Medication Score (SMS)	The SMS represents the sum of the mean daily symptom severity score plus the mean daily rescue medication score. The symptom severity score is defined as the mean of the daily symptom severity scores during the pollen season. The rescue medication score is defined as the mean of the daily rescue medication scores during the pollen season. A lower score indicates an improvement in the allergic condition. Minimum score of the SMS is "0", maximum score is dependent on intake of rescue medication.	From the start of treatment until the end of the relevant pollen exposition time.
Secondary	Combined Symptom and Medication Score (SMS)	The SMS represents the sum of the mean daily symptom severity score plus the mean daily rescue medication score. The symptom severity score is defined as the mean of the daily symptom severity scores during the pollen season. The overall severity rhinitis/rhinoconjunctivitis (including nasal itching, sneezing, rhinorrhea, nasal obstruction, ocular itching/grittiness/redness, and ocular tearing) and asthma (including chest tightness, shortness of breath, cough, wheezing) will be evaluated by the patient daily	date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months
Secondary	Onset of action (patient's assessment)	Patients will document the point in time when they experience onset of action of the therapy by answering the question "Do you have the feeling that your allergy symptoms are better or less due to SIT today?" with "Yes" or "No".	date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months
Secondary	Rhinoconjunctivitis Quality of Life questionnaire (RQLQ)	The RQLQ is a 28-item disease specific questionnaire designed to measure functional impairments that are most important to patients with rhinitis/rhinoconjunctivitis (Juniper and Guyatt 1991). It consists of 7 domains (activities, sleep, common complaints, practical problems, nasal symptoms, ocular symptoms, and emotions).	Visits 2, 4, 6, and 7

External Links

•   Results for CDPG103ADE01 from Novartis Clinical Trial Results website