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Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy

Primary Purpose

Allergic Rhinitis

Status

Unknown status

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Allergen extract

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
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 allergen 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

Allergen extract

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Symptom and medication score

Secondary Outcome Measures

Safety of sublingual application

Protocol of adverse events

Quality of Life Questionnaire

Evaluation of patients' related clinical global improvement

Full Information

NCT ID

NCT01014325

First Posted

November 11, 2009

Last Updated

November 2, 2015

Sponsor

Roxall Medizin

1. Study Identification

Unique Protocol Identification Number

NCT01014325

Brief Title

Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy

Official Title

Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

September 2017 (Anticipated)

Study Completion Date

September 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 clinical trial is to assess the safety and efficacy of sublingual application of allergen extracts for specific immunotherapy in patients suffering from perennial allergic rhinitis due to house dust mites.

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

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Allergen extract

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

Allergen extract

Intervention Description

sublingual application

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

sublingual application

Primary Outcome Measure Information:

Title

Symptom and medication score

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Safety of sublingual application

Time Frame

1 year

Title

Protocol of adverse events

Time Frame

1 year

Title

Quality of Life Questionnaire

Time Frame

1 year

Title

Evaluation of patients' related clinical global improvement

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 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 allergen 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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Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy

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