House Dust Mite Observational Study

NCT01949428 | Completed

• 1 other identifier: TH003
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rhinoconjunctivitis

Keywords

HDM Allergy; Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• To Document the combined Total Rhinocnjunctivitis Systom Scores (TRSS) and Total allergy medication score

  5 weeks

Study Arms (1)

HDM-Induced Rhinoconjunctivitis Subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Circassia Limited: lead
• Pharm-Olam International: collaborator

Study Sites (1)

Pharm-Olam

Mississauga, Ontario, L4Z 3E7, Canada

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: September 24, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 15, 2014

Record last verified: 2014-05

Locations

CA (1)