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

Primary Purpose

Allergic Rhinoconjunctivitis

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Depiquick Birch (DPG103)
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinoconjunctivitis

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Depiquick® Birch

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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".
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).

Full Information

First Posted
October 28, 2011
Last Updated
March 20, 2017
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01902992
Brief Title
Efficacy and Safety of Intraseasonal Specific Immunotherapy With Depiquick® Birch
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinoconjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Depiquick® Birch
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Depiquick Birch (DPG103)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Combined Symptom and Medication Score (SMS)
Description
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.
Time Frame
From the start of treatment until the end of the relevant pollen exposition time.
Secondary Outcome Measure Information:
Title
Combined Symptom and Medication Score (SMS)
Description
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
Time Frame
date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months
Title
Onset of action (patient's assessment)
Description
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".
Time Frame
date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months
Title
Rhinoconjunctivitis Quality of Life questionnaire (RQLQ)
Description
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).
Time Frame
Visits 2, 4, 6, and 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients must experience significant allergic symptoms on visit 2 Medical history of allergic rhinitis and/or rhinoconjunctivitis with clinically relevant sensitization to tree allergens Specific IgE against birch allergens (CAP RAST ≥ 2) Exclusion criteria: History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens FEV1 or PEF value ≤ 80 % Persistent asthma (GINA ≥ 2) Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Novartis Investigative Site
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Novartis Investigative Site
City
Augsburg
ZIP/Postal Code
86179
Country
Germany
Facility Name
Novartis Investigative Site
City
Bad Wildbad
ZIP/Postal Code
75323
Country
Germany
Facility Name
Novartis Investigative Site
City
Bad Woerishofen
ZIP/Postal Code
86825
Country
Germany
Facility Name
Novartis Investigative Site
City
Bensheim
ZIP/Postal Code
64625
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13057
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13187
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Novartis Investigative Site
City
Bochum
ZIP/Postal Code
44803
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Novartis Investigative Site
City
Chemnitz
ZIP/Postal Code
09130
Country
Germany
Facility Name
Novartis Investigative Site
City
Delitzsch
ZIP/Postal Code
04509
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
City
Duelmen
ZIP/Postal Code
48249
Country
Germany
Facility Name
Novartis Investigative Site
City
Duisburg
ZIP/Postal Code
47051
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Novartis Investigative Site
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Novartis Investigative Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04275
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04357
Country
Germany
Facility Name
Novartis Investigative Site
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Novartis Investigative Site
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
ZIP/Postal Code
48143
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Novartis Investigative Site
City
Neunkirchen
ZIP/Postal Code
66538
Country
Germany
Facility Name
Novartis Investigative Site
City
Nidderau
ZIP/Postal Code
61130
Country
Germany
Facility Name
Novartis Investigative Site
City
Oberhausen
ZIP/Postal Code
46145
Country
Germany
Facility Name
Novartis Investigative Site
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
Facility Name
Novartis Investigative Site
City
Rodgau
ZIP/Postal Code
63110
Country
Germany
Facility Name
Novartis Investigative Site
City
Wallenhorst
ZIP/Postal Code
49134
Country
Germany
Facility Name
Novartis Investigative Site
City
Wiesbaden
ZIP/Postal Code
64191
Country
Germany
Facility Name
Novartis Investigative Site
City
Wiesbaden
ZIP/Postal Code
65183
Country
Germany
Facility Name
Novartis Investigative Site
City
Witten
ZIP/Postal Code
58452
Country
Germany

12. IPD Sharing Statement

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Efficacy and Safety of Intraseasonal Specific Immunotherapy With Depiquick® Birch

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