N/A
N=434
Evaluating Symptom Control in in Allergic Rhinitis at Three Years After Starting Immunotherapy
Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01777438 ↗Enrolled (actual)
434
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Current Medication Use Three Years After Diagnosis of AR — 61; 29 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Current Medication Use Three Years After Diagnosis of AR |
61; 29 | — |
| PRIMARY Degree of Symptom Control 3 Years After IT or 3 Years After Medical Treatment With VAS of Total Nasal Symptom < 5/10 Defined as a Controlled Situation. |
3.7; 2.5 | — |
| SECONDARY Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment |
63; 84 | — |
| SECONDARY Percentage of Patients That Met ARIA Criteria for Mild AR Symtoms at a Mean Interval of 3 Years After Diagnosis |
32; 78 | — |
Summary
Allergic rhinitis (AR) is defined as inflammation of the nasal mucosa after exposition to an allergen in sensitized patients. AR causes not only nasal symptoms such as sneezing, itchy nose, rhinorrhea and nasal obstruction, but also has a significant impact on quality of life. Symptom control and overall satisfaction in patients undergoing subcutaneous immunotherapy (SCIT) or sublingual immunotherapy (SLIT) on the long term has not yet been investigated so far.
Eligibility Criteria
Inclusion Criteria
- Patients with at least 2 AR symptoms and a positive skin prick test for the 20 most prevalent inhalant allergens (house dust mites, grass pollen, tree pollen, animal dander, Alternaria, Penicillium and Cladosporium) in Belgium.
- Moderate/severe and/or persistent AR according to ARIA guidelines
- Age > 18 and 60 years
- Patients with mild AR
- Patients not being able to give an informed consent
- Patients being enrolled in other clinical trials
- No knowledge of Dutch, French or English
Data sourced from ClinicalTrials.gov (NCT01777438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.