House Dust Mite Observational Study

Circassia Pharmaceuticals

Status: Completed

Conditions: Rhinoconjunctivitis

Study type: Observational

Funder types: Industry

Identifiers

NCT01949428

TH003

Details and patient eligibility

About

A Field Study to Observe Symptom Scores and Allergy Medication Usage in Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis

Full description

House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.

The proposed observational study is designed to gather information on subjects with HDM-related rhinoconjunctivitis.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, aged 18-65 years
• A history of moderate to severe rhinoconjunctivitis (sneezing, rhinorrhoea, itchy nose, nasal blockage, and/or itchy/watery/red/sore eyes) consistent with allergy to HDM for at least 1 year.
• Non-asthmatic, or asthma controlled by Step 1 or 2 treatment as defined by GINA for at least one month.
• Subjects must have a 7-day reflective TRSS (i.e., reflective over the previous 7 days) of ≥12 and must have a score of ≥2 in at least two of the individual symptom components.
• Subjects must have Der p or Der f specific IgE ≥0.35 kU/L as measured by ImmunoCAP®. A blood draw for HDM-specific IgE must be performed during the Screening period.
• Subjects must have Der p or Der f specific IgE ≥0.35 kU/L as measured by ImmunoCAP®. A blood draw for HDM-specific IgE must be performed during the Screening period.

Exclusion criteria

• Clinically significant confounding symptoms of allergy to relevant local seasonal allergens (e.g., ragweed, mugwort, tree, grass, mountain cedar, mould) and cannot complete the Screening and Observation period outside the respective allergy seasons.
• Previous immunotherapy treatment with any HDMA for more than 1 month within 5 years prior to screening

Trial design

100 participants in 1 patient group

HDM-Induced Rhinoconjunctivitis Subjects