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Paediatric Safety Study in Cat-PAD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01921257
Recruitment Status : Completed
First Posted : August 13, 2013
Results First Posted : April 17, 2018
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
inVentiv Health Clinical
Information provided by (Responsible Party):
Circassia Limited

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

Condition or disease Intervention/treatment Phase
Rhinoconjunctivitis Drug: Cat-PAD Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: A Multi-Centre, Single-Blind Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects
Study Start Date : August 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921257


Locations
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Poland
Lodz, Poland
Tarnow, Poland
Warsaw, Poland
Sponsors and Collaborators
Circassia Limited
inVentiv Health Clinical

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Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT01921257     History of Changes
Other Study ID Numbers: CP009
First Posted: August 13, 2013    Key Record Dates
Results First Posted: April 17, 2018
Last Update Posted: May 14, 2018
Last Verified: May 2018

Keywords provided by Circassia Limited:
Cat Allergy
Rhinoconjunctivitis

Additional relevant MeSH terms:
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Conjunctivitis
Conjunctival Diseases
Eye Diseases