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A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts

This study is not yet open for participant recruitment.
Verified June 2011 by Roxall Medizin
Sponsor:
Information provided by:
Roxall Medizin
ClinicalTrials.gov Identifier:
NCT01012752
First received: November 11, 2009
Last updated: June 9, 2011
Last verified: June 2011
History of Changes
  Purpose

This trial is performed to evaluate the safety and clinical efficacy of subcutaneous specific immunotherapy in patients suffering from seasonal allergic rhinitis/rhinoconjunctivitis.


Condition Intervention Phase
Allergic Rhinitis
Allergic Conjunctivitis
 Biological: modified allergen extract
Biological: 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, Double-Blind, Placebo-Controlled Study With a Modified Allergen Extract for Specific Immunotherapy in Patients With Seasonal Allergic Rhinitis/Rhinoconjunctivitis

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever Pinkeye
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: 150
Study Start Date: November 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: modified allergen extract Biological: modified allergen extract
subcutaneous injections
Placebo Comparator: Placebo Biological: Placebo
subcutaneous injections

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive history of allergen specific allergic rhinitis/rhinoconjunctivitis
  • 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: NCT01012752

Contacts
Contact: Roxall Medizin +49408972520

Locations
Germany
Hamburg, Germany
Sponsors and Collaborators
Roxall Medizin
  More Information

No publications provided

Responsible Party: Roxall Medizin
ClinicalTrials.gov Identifier: NCT01012752     History of Changes
Other Study ID Numbers: SBC-2009-003B
Study First Received: November 11, 2009
Last Updated: June 9, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on May 21, 2013