NCT01604018

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
Last Updated

May 24, 2012

Status Verified

May 1, 2012

Enrollment Period

2 months

First QC Date

May 21, 2012

Last Update Submit

May 23, 2012

Conditions

Cat AllergyRhinoconjunctivitis

Keywords

Cat AllergyRhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Total Rhinoconjunctivitis Symptom Score

    102-106 weeks after the start of treatment in CP005

Secondary Outcomes (1)

  • Total Symptom scores for ocular and nasal symptoms

    102-106 weeks after the start of treatment in CP005

Study Arms (3)

Placebo

Subjects previously randomized to receive placebo in study CP005 and completed CP005A.

Cat-PAD Group 1

Subjects previously randomized to receive Cat-PAD dose 1 in study CP005 and completed CP005A.

Cat-Pad Group 2

Subjects previously randomized to receive Cat-PAD dose 2 in study CP005 and completed CP005A.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects previously randomised in study CP005 and completed all dosing and PTC in CP005 and all visits in CP005A.

You may qualify if:

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

You may not qualify if:

  • "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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cetero Research

Mississauga, Ontario, Canada

Location

Study Officials

  • Peter Couroux, MD

    Cetero Research, San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 23, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

May 24, 2012

Record last verified: 2012-05

Locations

CA(1)