Allergic Rhinitis (w/w Asthma) Due to Alternaria Alternata Clinical Trial
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
| Verified date | January 2008 |
| Source | University of Genova |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 27 |
| Est. completion date | October 2008 |
| Est. primary completion date | October 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 14 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Rimini Hospital | Rimini |
| Lead Sponsor | Collaborator |
|---|---|
| University of Genova |
Italy,
Tabar AI, Lizaso MT, García BE, Gómez B, Echechipía S, Aldunate MT, Madariaga B, Martínez A. Double-blind, placebo-controlled study of Alternaria alternata immunotherapy: clinical efficacy and safety. Pediatr Allergy Immunol. 2008 Feb;19(1):67-75. Epub 2007 Jul 25. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change in symptom score active versus placebo | |||
| Secondary | change in rescue medication intake |