Skip to main content
OpenTrials
Completed

NCT Number: NCT01272323

Cat-PAD Follow on Study

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 approximately one year after the start of treatment.

Completed

Looking for future studies?

Notify Me

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 dosing visits and the post treatment challenge (PTC) in study CP005 will be invited to attend the Screening Visit for CP005A. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit a follow-up visit 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 in study CP005, completed all treatment visits and the Post Treatment Challenge (PTC).

Exclusion criteria

  • "Partly controlled" and "uncontrolled" asthma
  • History of anaphylaxis to cat allergen
  • FEV1 of less than 70% of predicted
  • Subjects who cannot tolerate baseline challenge in the EEC
  • Treatment with beta-blockers,Alpha-adrenoceptor blockers, Tranquillizers or psychoactive drugs
  • A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment)

Treatment and study plan

Placebo

Biological

No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.

Cat-PAD Dose 1

Biological

No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.

Cat-PAD Dose 2

Biological

No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.

Primary outcomes

  1. Total Rhinoconjunctivitis Symptom Score

    Time frame: 50-54 weeks after the start of treatment in CP005

Secondary outcomes

  1. Total Symptom scores for ocular and nasal symptoms

    Time frame: 50-54 weeks after the start of treatment in CP005

Sponsors and collaborators

Lead sponsor

Circassia Limited

Industry

Collaborators

  • Adiga Life Sciences, Inc.
  • Cetero Research, San Antonio

Registry information

Official study title

An Optional 1 Year Follow up Study to Evaluate the Continued Efficacy of Cat-PAD in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 7, 2011
Registry last updated
May 20, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.