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ToleroMune House Dust Mite (HDM) Tolerability Study

Primary Purpose

Rhinoconjunctivitis

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
ToleroMune HDM
Placebo
Sponsored by
Circassia Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinoconjunctivitis focused on measuring HDM Allergy, Rhinoconjunctivitis, Immunotherapy, ToleroMune HDM

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, aged 18-65 years.
  • Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation.
  • Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation.
  • No change in asthma controller treatment (dose, frequency) in the four weeks prior to randomisation.
  • A reliable history consistent with rhinoconjunctivitis on exposure to HDM for at least 1 year that has required symptomatic treatment on at least one occasion during the year prior to randomisation
  • Positive skin prick test to Dermatophagoides pteronyssinus with an average wheal diameter at least 5 mm larger than that produced by the negative control.
  • ImmunoCAP® Dermatophagoides pteronyssinus-specific Immunoglobulin E ≥ 0.35 kU/L.

Exclusion Criteria:

  • History of life-threatening asthma
  • Asthma exacerbation in the 12 weeks prior to randomisation
  • Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) < 80 % of predicted, regardless of the cause.
  • Post-bronchodilator FEV1/Forced Vital Capacity ratio of < 0.7.
  • Concurrent respiratory disease that would confound study participation or affect subject safety.

  • Non-HDM allergy that may significantly interfere with the results of this study.

    7. Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening.

Sites / Locations

  • Topstone Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ToleroMune HDM

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Adverse Events

Secondary Outcome Measures

FEV1 and FVC
Peak Expiratory Flow Rate
VAS Breathlessness
Asthma Exacerbations
Systemic Allergic Reactions
Injection Site Examinations

Full Information

First Posted
September 20, 2013
Last Updated
June 10, 2014
Sponsor
Circassia Limited
Collaborators
Adiga Life Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01949441
Brief Title
ToleroMune House Dust Mite (HDM) Tolerability Study
Official Title
A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Tolerability of ToleroMune House Dust Mite in Subjects With Controlled Asthma and House Dust Mite-Induced Rhinoconjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Circassia Limited
Collaborators
Adiga Life Sciences, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
House Dust Mites (HDMs) 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. ToleroMune House Dust Mite (TM-HDM), a combination of seven Synthetic Peptide Immuno-Regulatory Epitopes, is being developed for the treatment of HDM allergy. This study to assess the tolerability of ToleroMune House Dust Mite in subjects with controlled asthma and house dust mite-induced rhinoconjunctivitis.
Detailed Description
A multi-centre, randomised, double-blind, placebo-controlled, parallel-group, multiple dose study to evaluate the tolerability of four intradermal doses of TM-HDM in subjects with controlled asthma and HDM-induced rhinoconjunctivitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinoconjunctivitis
Keywords
HDM Allergy, Rhinoconjunctivitis, Immunotherapy, ToleroMune HDM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ToleroMune HDM
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
ToleroMune HDM
Intervention Description
Intradermal injection 1 x 4 administrations 4 weeks apart
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Intradermal injection 1 x 4 administrations 4 weeks apart
Primary Outcome Measure Information:
Title
Adverse Events
Time Frame
Up to 19 Weeks
Secondary Outcome Measure Information:
Title
FEV1 and FVC
Time Frame
Up to 19 Weeks
Title
Peak Expiratory Flow Rate
Time Frame
Up to 19 Weeks
Title
VAS Breathlessness
Time Frame
Up to 19 weeks
Title
Asthma Exacerbations
Time Frame
Up to 19 weeks
Title
Systemic Allergic Reactions
Time Frame
Up to 19 Weeks
Title
Injection Site Examinations
Time Frame
Up to 19 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, aged 18-65 years. Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation. Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation. No change in asthma controller treatment (dose, frequency) in the four weeks prior to randomisation. A reliable history consistent with rhinoconjunctivitis on exposure to HDM for at least 1 year that has required symptomatic treatment on at least one occasion during the year prior to randomisation Positive skin prick test to Dermatophagoides pteronyssinus with an average wheal diameter at least 5 mm larger than that produced by the negative control. ImmunoCAP® Dermatophagoides pteronyssinus-specific Immunoglobulin E ≥ 0.35 kU/L. Exclusion Criteria: History of life-threatening asthma Asthma exacerbation in the 12 weeks prior to randomisation Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) < 80 % of predicted, regardless of the cause. Post-bronchodilator FEV1/Forced Vital Capacity ratio of < 0.7. Concurrent respiratory disease that would confound study participation or affect subject safety. Non-HDM allergy that may significantly interfere with the results of this study. 7. Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening.
Facility Information:
Facility Name
Topstone Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9C 4Z5
Country
Canada

12. IPD Sharing Statement

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ToleroMune House Dust Mite (HDM) Tolerability Study

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