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Sublingual Immunotherapy In Alternaria-Induced Rhinitis

Primary Purpose

Allergic Rhinitis (w/w Asthma) Due to Alternaria Alternata

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
sublingual immunotherapy
placebo
Sponsored by
University of Genova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis (w/w Asthma) Due to Alternaria Alternata focused on measuring allergic rhinitis, alternaria alternata, symptom score

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Allergic rhinitis
  • Symptoms May-October
  • Specific IgE to alternaria (skin test/radioallergosorbent [RAST] test)
  • Age >14

Exclusion Criteria:

  • Sensitization to mites, parietaria, mugwort
  • Pregnancy-lactation
  • Malignancies
  • Chronic systemic steroids
  • Previous immunotherapy to alternaria

Sites / Locations

  • Rimini Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SLIT

placebo

Arm Description

sublingual immunotherapy biologically standardized

same preparation of SLIT without the allergen

Outcomes

Primary Outcome Measures

change in symptom score active versus placebo

Secondary Outcome Measures

change in rescue medication intake

Full Information

First Posted
May 19, 2010
Last Updated
June 4, 2010
Sponsor
University of Genova
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1. Study Identification

Unique Protocol Identification Number
NCT01127035
Brief Title
Sublingual Immunotherapy In Alternaria-Induced Rhinitis
Official Title
STUDIO IN DOPPIO CIECO DISODIOCROMOGLICATO + PLACEBO vs DISODIOCROMOGLICATO + IMMUNOTERAPIA SPECIFICA SUBLINGUALE PER ALTERNARIA IN PAZIENTI CON RINITE ALLERGICA DOVUTA A SENSIBILIZZAZIONE AD ALTERNARIA
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Genova

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Respiratory allergy due to Alternaria is a relevant clinical problem, and specific immunotherapy may represent a viable treatment option. Sublingual immunotherapy (SLIT) is safe and effective, but data for Alternaria are lacking. The study is aimed at assessing the efficacy of a standardized SLIT in patients sensitised to Alternaria, in a randomized, double blind, placebo controlled fashion. Patients with rhinitis with/without intermittent asthma, and ascertained allergy to Alternaria are enrolled. After a baseline season, SLIT or matched placebo are given for 10 months. Symptoms and rescue medication intake are recorded on diary cards from June to October. Skin prick test, specific IgE and IgG4 and precipitins are measured at baseline and at the end of the study. Alternaria spore count is also performed. Primary outcome is the change in symptom score in the active vs placebo group. Secondary outcomes: changes in rescue medication intake, alternaria specific IgE and IgG4, skin prick test reactivity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis (w/w Asthma) Due to Alternaria Alternata
Keywords
allergic rhinitis, alternaria alternata, symptom score

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SLIT
Arm Type
Experimental
Arm Description
sublingual immunotherapy biologically standardized
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
same preparation of SLIT without the allergen
Intervention Type
Biological
Intervention Name(s)
sublingual immunotherapy
Intervention Type
Biological
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
change in symptom score active versus placebo
Secondary Outcome Measure Information:
Title
change in rescue medication intake

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Allergic rhinitis Symptoms May-October Specific IgE to alternaria (skin test/radioallergosorbent [RAST] test) Age >14 Exclusion Criteria: Sensitization to mites, parietaria, mugwort Pregnancy-lactation Malignancies Chronic systemic steroids Previous immunotherapy to alternaria
Facility Information:
Facility Name
Rimini Hospital
City
Rimini
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17651380
Citation
Tabar AI, Lizaso MT, Garcia BE, Gomez B, Echechipia S, Aldunate MT, Madariaga B, Martinez A. Double-blind, placebo-controlled study of Alternaria alternata immunotherapy: clinical efficacy and safety. Pediatr Allergy Immunol. 2008 Feb;19(1):67-75. doi: 10.1111/j.1399-3038.2007.00589.x. Epub 2007 Jul 25.
Results Reference
background
PubMed Identifier
21055665
Citation
Cortellini G, Spadolini I, Patella V, Fabbri E, Santucci A, Severino M, Corvetta A, Canonica GW, Passalacqua G. Sublingual immunotherapy for Alternaria-induced allergic rhinitis: a randomized placebo-controlled trial. Ann Allergy Asthma Immunol. 2010 Nov;105(5):382-6. doi: 10.1016/j.anai.2010.08.007. Epub 2010 Sep 26.
Results Reference
derived

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Sublingual Immunotherapy In Alternaria-Induced Rhinitis

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