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A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts

Primary Purpose

Allergic Rhinitis, Allergic Conjunctivitis

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
modified allergen extract
Placebo
Sponsored by
Roxall Medizin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Positive history of allergen specific allergic rhinitis/rhinoconjunctivitis
  • Positive screening skin prick test (wheal diameter > 3 mm)
  • Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
  • Signed and dated patient´s Informed Consent,

Exclusion Criteria:

  • Previous immunotherapy within the last 3 years,
  • Simultaneous participation in other clinical trials,
  • Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
  • Auto-immune disorders,
  • Severe chronic inflammatory diseases,
  • Malignancy,
  • Alcohol abuse,
  • Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
  • Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

modified allergen extract

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Symptom and medication score

Secondary Outcome Measures

Safety of the treatment
Documentation of adverse events
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Clinical global improvement

Full Information

First Posted
November 11, 2009
Last Updated
November 2, 2015
Sponsor
Roxall Medizin
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1. Study Identification

Unique Protocol Identification Number
NCT01012752
Brief Title
A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts
Official Title
A Multicenter, Double-Blind, Placebo-Controlled Study With a Modified Allergen Extract for Specific Immunotherapy in Patients With Seasonal Allergic Rhinitis/Rhinoconjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roxall Medizin

4. Oversight

5. Study Description

Brief Summary
This trial is performed to evaluate the safety and clinical efficacy of subcutaneous specific immunotherapy in patients suffering from seasonal allergic rhinitis/rhinoconjunctivitis.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
modified allergen extract
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
modified allergen extract
Intervention Description
subcutaneous injections
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
subcutaneous injections
Primary Outcome Measure Information:
Title
Symptom and medication score
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Safety of the treatment
Time Frame
1 year
Title
Documentation of adverse events
Time Frame
1 year
Title
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time Frame
1 year
Title
Clinical global improvement
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Positive history of allergen specific allergic rhinitis/rhinoconjunctivitis Positive screening skin prick test (wheal diameter > 3 mm) Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication Signed and dated patient´s Informed Consent, Exclusion Criteria: Previous immunotherapy within the last 3 years, Simultaneous participation in other clinical trials, Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance), Auto-immune disorders, Severe chronic inflammatory diseases, Malignancy, Alcohol abuse, Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection, Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roxall Medizin
Phone
+49408972520
Facility Information:
City
Hamburg
Country
Germany

12. IPD Sharing Statement

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A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts

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