Status:
COMPLETED
Paediatric Safety Study in Cat-PAD
Lead Sponsor:
Circassia Limited
Collaborating Sponsors:
inVentiv Health Clinical
Conditions:
Rhinoconjunctivitis
Eligibility:
All Genders
5-11 years
Phase:
PHASE2
Brief Summary
Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01921257
Start Date
August 1 2013
End Date
December 1 2015
Last Update
May 14 2018
Active Locations (3)
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1
Lodz, Poland
2
Tarnów, Poland
3
Warsaw, Poland