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Efficacy and Safety of Sublingual Immunotherapy (SLIT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Roxall Medizin.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Roxall Medizin
ClinicalTrials.gov Identifier:
NCT01012882
First received: November 11, 2009
Last updated: July 13, 2011
Last verified: November 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Further study details as provided by Roxall Medizin:

Primary Outcome Measures:
  • Symptom and medication score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: November 2012 (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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Roxall Medizin
ClinicalTrials.gov Identifier: NCT01012882     History of Changes
Other Study ID Numbers: SLG-2009-005B
Study First Received: November 11, 2009
Last Updated: July 13, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on June 18, 2013