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

November 2, 2015 updated by: Roxall Medizin

A Multicenter, Double-Blind, Placebo-Controlled Study With a Modified Allergen Extract for Specific Immunotherapy in Patients With Seasonal Allergic Rhinitis/Rhinoconjunctivitis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: Placebo
subcutaneous injections
Active Comparator: modified allergen extract
Biological: modified allergen extract
subcutaneous injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptom and medication score
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety of the treatment
Time Frame: 1 year
1 year
Documentation of adverse events
Time Frame: 1 year
1 year
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Time Frame: 1 year
1 year
Clinical global improvement
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roxall Medizin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

November 11, 2009

First Submitted That Met QC Criteria

November 12, 2009

First Posted (Estimate)

November 13, 2009

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBC-2009-003B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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