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Efficacy and Safety of Sublingual Immunotherapy (SLIT)

This study is not yet open for participant recruitment.
Verified November 2015 by Roxall Medizin
Sponsor:
ClinicalTrials.gov Identifier:
NCT01012882
First Posted: November 13, 2009
Last Update Posted: November 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Roxall Medizin
  Purpose
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 .

Condition Intervention Phase
Allergic Rhinitis Biological: sublingual immunotherapy with allergen extract Biological: sublingual immunotherapy with placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized DBPC Trial to Evaluate Efficacy and Safety of Sublingual Immunotherapy (SLIT) With Allergen Extracts From Pollen in Patients With Seasonal Allergic Rhinitis

Further study details as provided by Roxall Medizin:

Primary Outcome Measures:
  • Symptom and medication score [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Safety of the treatment [ Time Frame: 1 year ]
  • Documentation of adverse events [ Time Frame: 1 year ]
  • Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: 1 year ]
  • Clinical global improvement [ Time Frame: 1 year ]

Estimated Enrollment: 120
Study Start Date: November 2016
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sublingual application of allergen extract Biological: sublingual immunotherapy with allergen extract
sublingual application
Placebo Comparator: sublingual application of placebo Biological: sublingual immunotherapy with placebo
sublingual application

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012882


Contacts
Contact: Roxall Medizin 0049408972520 info@roxall.de

Locations
Germany
Roxall Medizin Not yet recruiting
Hamburg, Germany
Sponsors and Collaborators
Roxall Medizin
  More Information

Responsible Party: Roxall Medizin
ClinicalTrials.gov Identifier: NCT01012882     History of Changes
Other Study ID Numbers: SLG-2009-005B
First Submitted: November 11, 2009
First Posted: November 13, 2009
Last Update Posted: November 3, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases


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