Paediatric Safety Study in Cat-PAD

May 11, 2018 updated by: Circassia Limited

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lodz, Poland
      • Tarnow, Poland
      • Warsaw, Poland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Cat-PAD and Placebo
Drug: Placebo
Drug: Cat-PAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 36 weeks after start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Circassia Limited

Collaborators

inVentiv Health Clinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 17, 2013

First Submitted That Met QC Criteria

August 9, 2013

First Posted (Estimate)

August 13, 2013

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 11, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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