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Efficacy and Safety of Intraseasonal Specific Immunotherapy With Depiquick® Birch (INSIDE)

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ClinicalTrials.gov Identifier: NCT01902992
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

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.

Condition or disease Intervention/treatment Phase
Allergic Rhinoconjunctivitis Drug: Depiquick Birch (DPG103) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: 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.
Drug: Depiquick Birch (DPG103)
Placebo Comparator: 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.
Drug: Placebo



Primary Outcome Measures :
  1. Combined Symptom and Medication Score (SMS) [ Time Frame: From the start of treatment until the end of the relevant pollen exposition time. ]
    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.


Secondary Outcome Measures :
  1. Combined Symptom and Medication Score (SMS) [ Time Frame: date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months ]
    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

  2. Onset of action (patient's assessment) [ Time Frame: date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months ]
    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".

  3. Rhinoconjunctivitis Quality of Life questionnaire (RQLQ) [ Time Frame: Visits 2, 4, 6, and 7 ]
    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).



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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902992


Locations
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Germany
Novartis Investigative Site
Aachen, Germany, 52074
Novartis Investigative Site
Aschaffenburg, Germany, 63739
Novartis Investigative Site
Augsburg, Germany, 86179
Novartis Investigative Site
Bad Wildbad, Germany, 75323
Novartis Investigative Site
Bad Woerishofen, Germany, 86825
Novartis Investigative Site
Bensheim, Germany, 64625
Novartis Investigative Site
Berlin, Germany, 13057
Novartis Investigative Site
Berlin, Germany, 13187
Novartis Investigative Site
Berlin, Germany, 14050
Novartis Investigative Site
Bochum, Germany, 44803
Novartis Investigative Site
Bonn, Germany, 53105
Novartis Investigative Site
Chemnitz, Germany, 09130
Novartis Investigative Site
Delitzsch, Germany, 04509
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Duelmen, Germany, 48249
Novartis Investigative Site
Duisburg, Germany, 47051
Novartis Investigative Site
Frankfurt, Germany, 60389
Novartis Investigative Site
Gera, Germany, 07548
Novartis Investigative Site
Hannover, Germany, 30159
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Leipzig, Germany, 04275
Novartis Investigative Site
Leipzig, Germany, 04357
Novartis Investigative Site
Luebeck, Germany, 23538
Novartis Investigative Site
Lübeck, Germany, 23538
Novartis Investigative Site
Muenster, Germany, 48143
Novartis Investigative Site
Muenster, Germany, 48149
Novartis Investigative Site
Neunkirchen, Germany, 66538
Novartis Investigative Site
Nidderau, Germany, 61130
Novartis Investigative Site
Oberhausen, Germany, 46145
Novartis Investigative Site
Osnabrück, Germany, 49074
Novartis Investigative Site
Rodgau, Germany, 63110
Novartis Investigative Site
Wallenhorst, Germany, 49134
Novartis Investigative Site
Wiesbaden, Germany, 64191
Novartis Investigative Site
Wiesbaden, Germany, 65183
Novartis Investigative Site
Witten, Germany, 58452
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01902992     History of Changes
Other Study ID Numbers: CDPG103ADE01
2011-004185-14 ( EudraCT Number )
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases