Phase 2
Completed N=16
Paediatric Safety Study in Cat-PAD
Rhinoconjunctivitis
Source: ClinicalTrials.gov NCT01921257 ↗
Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Apr 2018
Primary outcomePrimary: Number of Subjects With AEs — 5; 12 participants
Summary
Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With AEs |
5; 12 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01921257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.