Paediatric Safety Study in Cat-PAD

Circassia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Rhinoconjunctivitis

Treatments: Drug: Placebo; Drug: Cat-PAD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01921257

CP009

Details and patient eligibility

About

Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects

Enrollment: 16 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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16 participants in 1 patient group

Treatment

Experimental group

Description:

Cat-PAD and Placebo

Treatment:

Drug: Placebo

Drug: Cat-PAD