Paediatric Safety Study in Cat-PAD
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 5 - 11 |
| Updated: | 8/8/2015 |
| Start Date: | August 2013 |
| End Date: | December 2015 |
| Contact: | Irina Medvedeva |
| Email: | irina.medvedeva@inventivhealth.com |
A Multi-Centre, Single-Blind Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects
Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects
- 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.
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