House Dust Mite Observational Study

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

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

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L4Z 3E7
      • Pharm-Olam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
HDM-Induced Rhinoconjunctivitis Subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To Document the combined Total Rhinocnjunctivitis Systom Scores (TRSS) and Total allergy medication score	5 weeks

Collaborators and Investigators

• Sponsor: Circassia Limited
• Collaborators: Pharm-Olam International

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: September 20, 2013
• First Submitted That Met QC Criteria: September 20, 2013
• First Posted (ESTIMATE): September 24, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 15, 2014
• Last Update Submitted That Met QC Criteria: May 14, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Rhinoconjunctivitis; HDM Allergy
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Conjunctivitis
• Other Study ID Numbers: TH003