House Dust Mite Observational Study

Rhinoconjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949428
• Other study ID #: TH003
• Status: Completed
• Phase: N/A
• First received: September 20, 2013
• Last updated: May 14, 2014
• Start date: September 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Conjunctivitis
• Rhinoconjunctivitis

Locations

Country	Name	City	State
Canada	Pharm-Olam	Mississauga	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Circassia Limited	Pharm-Olam International

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Document the combined Total Rhinocnjunctivitis Systom Scores (TRSS) and Total allergy medication score		5 weeks	No