House Dust Mite Observational Study

Completed

• Conditions: Rhinoconjunctivitis

• Registration Number: NCT01949428
• Lead Sponsor: Circassia Limited

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-20
• Study First Submitted QC: 2013-09-20
• Study First Posted: 2013-09-24
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-14
• Last Update Posted: 2014-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To Document the combined Total Rhinocnjunctivitis Systom Scores (TRSS) and Total allergy medication score	5 weeks

Trial Locations

Locations (1)

Pharm-Olam; 🇨🇦 Mississauga, Ontario, Canada