Efficacy and Safety of Sublingual Immunotherapy (SLIT)

NCT ID: NCT01012882

Last Updated: 2015-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-11-30

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of specific sublingual immunotherapy (SLIT) with allergen extracts in patients suffering from seasonal allergic rhinitis .

Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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sublingual application of allergen extract

Group Type EXPERIMENTAL

sublingual immunotherapy with allergen extract

Intervention Type BIOLOGICAL

sublingual application

sublingual application of placebo

Group Type PLACEBO_COMPARATOR

sublingual immunotherapy with placebo

Intervention Type BIOLOGICAL

sublingual application

Interventions

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sublingual immunotherapy with allergen extract

sublingual application

Intervention Type BIOLOGICAL

sublingual immunotherapy with placebo

sublingual application

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Positive history of allergen specific seasonal 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 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roxall Medizin

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Roxall Medizin

Hamburg, , Germany

Site Status

Countries

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Germany

Central Contacts

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Roxall Medizin

Role: CONTACT

0049408972520

Other Identifiers

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SLG-2009-005B

Identifier Type: -

Identifier Source: org_study_id

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