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CompletedNCT01949428Updated May 15, 2014

House Dust Mite Observational Study

An observational study in Rhinoconjunctivitis, sponsored by Circassia Limited. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-05-15.

Sponsored by Circassia Limited · Observational

Study type
Observational
Model
Cohort
Enrollment
100
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Rhinoconjunctivitis

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Keywords

  • HDM Allergy
  • Rhinoconjunctivitis
03

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 100 is below the median of 152 across 47 observational studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

Circassia Limited is the lead sponsor of 35 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects with a History of House Dust Mite-Induced Rhinoconjunctivitis

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

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
05

Study design

Observational model
Cohort
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • HDM-Induced Rhinoconjunctivitis Subjects
06

What researchers measure

Primary outcomes

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

    Time frame: 5 weeks

07

Study locations

1 site
  • Pharm-Olam
    Mississauga, Ontario L4Z 3E7, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01949428
Lead sponsor
Circassia Limited
Collaborators
Pharm-Olam International
Responsible party
Sponsor
First posted
Sep 24, 2013
Start date
Sep 2013
Primary completion
Mar 2014
Completion
Mar 2014
Last update
May 15, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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