Paediatric Safety Study in Cat-PAD

Rhinoconjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921257
• Other study ID #: CP009
• Status: Completed
• Phase: Phase 2
• Start date: August 2013
• Est. completion date: December 2015

Study information

• Verified date: May 2018
• Source: Circassia Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Conjunctivitis
• Rhinoconjunctivitis

Intervention

Drug:
• Cat-PAD

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Circassia Limited	inVentiv Health Clinical

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With AEs	To evaluate the safety and tolerability of Cat-PAD in paediatric subjects aged 5 to <12 years.	up to 36 weeks after start of treatment