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Completed

NCT Number: NCT01604018

An Optional Two Year Follow Up Study to Study CP005A

Cat allergy is an increasingly prevalent condition affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma.

The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who completed all dosing visits in study CP005 and all visits in study CP005A approximately two years after the start of treatment.

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Key information

Conditions

Cat Allergy Rhinoconjunctivitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cetero Research

Mississauga, Ontario, Canada

About this study

Subjects who completed all visits in studies CP005 and CP005A will be invited to attend the Screening Visit for CP005B. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit is a follow-up visit which will be performed 3-10 days later.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Previously randomised into study CP005 and completed all visits in the follow-on study CP005A

Exclusion criteria

  • "Partly controlled" and "uncontrolled" asthma
  • History of anaphylaxis to cat allergen
  • Subjects with an FEV1 < 70% of predicted
  • Subjects who cannot tolerate baseline challenge in the EEC
  • Treatment with beta-blockers, alpha-adrenoceptor blockers, tranquilizers, or psychoactive drugs
  • Symptoms of a clinically relevant illness, in the Investigator's opinion, within 6 weeks prior to Screening Visit

Treatment and study plan

Primary outcomes

  1. Total Rhinoconjunctivitis Symptom Score

    Time frame: 102-106 weeks after the start of treatment in CP005

Secondary outcomes

  1. Total Symptom scores for ocular and nasal symptoms

    Time frame: 102-106 weeks after the start of treatment in CP005

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • Adiga Life Sciences, Inc.
  • Cetero Research, Toronto

Registry information

Official study title

An Optional Two Year Follow Up Study to Evaluate the Continued Efficacy of Cat-PAD ToleroMune Peptide Immunotherapy in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 23, 2012
Registry last updated
May 24, 2012

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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