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Completed

NCT Number: NCT01921257

Paediatric Safety Study in Cat-PAD

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

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Key information

Conditions

Rhinoconjunctivitis

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lodz, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Cat-PAD

Drug

Placebo

Drug

Primary outcomes

  1. Number of Subjects With AEs

    Time frame: up to 36 weeks after start of treatment

    To evaluate the safety and tolerability of Cat-PAD in paediatric subjects aged 5 to <12 years.

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • inVentiv Health Clinical

Registry information

Official study title

A Multi-Centre, Single-Blind Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2013
Registry last updated
May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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