Back to resultsPaediatric Safety Study in Cat-PAD
Primary Purpose
Rhinoconjunctivitis
Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Cat-PAD
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rhinoconjunctivitis focused on measuring Cat Allergy, Rhinoconjunctivitis
Eligibility Criteria
Inclusion Criteria
- Male or female, aged 5-12 years.
- Moderate to severe rhinoconjunctivitis on exposure to cats for at least 2 years.
- Subjects may optionally also have GINA Step 1 controlled asthma.
- Positive skin prick test to cat hair.
- Cat dander specific IgE ≥0.35 kU/L.
Exclusion Criteria
- Asthma falling under the GINA definitions "partly controlled" and "uncontrolled" or Steps 2 to 5.
- FEV1 <80% of predicted.
- Clinically relevant abnormalities detected on physical examination.
- History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Cat-PAD and Placebo
Outcomes
Primary Outcome Measures
Number of Subjects With AEs
To evaluate the safety and tolerability of Cat-PAD in paediatric subjects aged 5 to <12 years.
Secondary Outcome Measures
Full Information
NCT ID
NCT01921257
First Posted
July 17, 2013
Last Updated
May 11, 2018
Sponsor
Circassia Limited
Collaborators
inVentiv Health Clinical
1. Study Identification
Unique Protocol Identification Number
NCT01921257
Brief Title
Paediatric Safety Study in Cat-PAD
Official Title
A Multi-Centre, Single-Blind Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Circassia Limited
Collaborators
inVentiv Health Clinical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinoconjunctivitis
Keywords
Cat Allergy, Rhinoconjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Cat-PAD and Placebo
Intervention Type
Drug
Intervention Name(s)
Cat-PAD
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Subjects With AEs
Description
To evaluate the safety and tolerability of Cat-PAD in paediatric subjects aged 5 to <12 years.
Time Frame
up to 36 weeks after start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Male or female, aged 5-12 years.
Moderate to severe rhinoconjunctivitis on exposure to cats for at least 2 years.
Subjects may optionally also have GINA Step 1 controlled asthma.
Positive skin prick test to cat hair.
Cat dander specific IgE ≥0.35 kU/L.
Exclusion Criteria
Asthma falling under the GINA definitions "partly controlled" and "uncontrolled" or Steps 2 to 5.
FEV1 <80% of predicted.
Clinically relevant abnormalities detected on physical examination.
History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
Facility Information:
City
Lodz
Country
Poland
City
Tarnow
Country
Poland
City
Warsaw
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Paediatric Safety Study in Cat-PAD
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