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Evaluation of Efficacy and Safety of Specific Immunotherapy With Modified Allergen Extracts of House Dust Mites

Primary Purpose

Allergic Rhinitis

Status

Unknown status

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

modified allergen extract of house dust mites

placebo

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Positive history of perennial allergic rhinitis due to house dust mites
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 with mite extracts 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

Experimental

Placebo Comparator

Arm Label

modified allergen extract of house dust mites

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Symptom and medication score

Secondary Outcome Measures

Safety of the treatment

Documentation of adverse events

Clinical global improvement

Quality of Life Questionnaire

Full Information

NCT ID

NCT01013116

First Posted

November 11, 2009

Last Updated

November 2, 2015

Sponsor

Roxall Medizin

1. Study Identification

Unique Protocol Identification Number

NCT01013116

Brief Title

Evaluation of Efficacy and Safety of Specific Immunotherapy With Modified Allergen Extracts of House Dust Mites

Official Title

A Double-blind Placebo-controlled Trial to Evaluate Efficacy and Safety of Specific Subcutaneous Immunotherapy in Patients With Perennial Allergic Rhinitis Due to House Dust Mites

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

April 2016 (undefined)

Primary Completion Date

April 2017 (Anticipated)

Study Completion Date

April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Roxall Medizin

4. Oversight

5. Study Description

Brief Summary

The objective of this study is to evaluate the efficacy and safety of specific subcutaneous immunotherapy with modified allergen extracts.

6. Conditions and Keywords

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

Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

modified allergen extract of house dust mites

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

modified allergen extract of house dust mites

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

Clinical global improvement

Time Frame

1 year

Title

Quality of Life Questionnaire

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Positive history of perennial allergic rhinitis due to house dust mites 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 with mite extracts 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

Madrid

Country

Spain

12. IPD Sharing Statement

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Evaluation of Efficacy and Safety of Specific Immunotherapy With Modified Allergen Extracts of House Dust Mites

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