NCT01127035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2010

Completed
Last Updated

June 7, 2010

Status Verified

January 1, 2008

Enrollment Period

2.8 years

First QC Date

May 19, 2010

Last Update Submit

June 4, 2010

Conditions

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

Keywords

allergic rhinitisalternaria alternatasymptom score

Outcome Measures

Primary Outcomes (1)

  • change in symptom score active versus placebo

Secondary Outcomes (1)

  • change in rescue medication intake

Study Arms (2)

SLIT

EXPERIMENTAL

sublingual immunotherapy biologically standardized

Biological: sublingual immunotherapy

placebo

PLACEBO COMPARATOR

same preparation of SLIT without the allergen

Biological: placebo

Interventions

sublingual immunotherapyBIOLOGICAL
SLIT
placeboBIOLOGICAL
placebo

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rimini Hospital

Rimini, Italy

Location

Related Publications (2)

  • 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.

    PMID: 17651380BACKGROUND

  • 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.

    PMID: 21055665DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Sublingual Immunotherapy

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Desensitization, ImmunologicImmunosuppression TherapyImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2010

First Posted

May 20, 2010

Study Start

January 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

June 7, 2010

Record last verified: 2008-01

Locations

IT(1)