Paediatric Safety Study in Cat-PAD

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Rhinoconjunctivitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Treatment

Cat-PAD and Placebo

Group Type EXPERIMENTAL

Cat-PAD

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Cat-PAD

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No