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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01604018
Other study ID # CP005B
Secondary ID
Status Completed
Phase N/A
First received May 21, 2012
Last updated May 23, 2012
Start date February 2012
Est. completion date April 2012

Study information

Verified date May 2012
Source Circassia Limited
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Cetero Research Mississauga Ontario

Sponsors (3)

Lead Sponsor Collaborator
Circassia Limited Adiga Life Sciences, Inc., Cetero Research, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Rhinoconjunctivitis Symptom Score 102-106 weeks after the start of treatment in CP005 No
Secondary Total Symptom scores for ocular and nasal symptoms 102-106 weeks after the start of treatment in CP005 No
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