A Double-Blind, Randomised, Placebo-Controlled Study to Evaluate the Efficacy of Cat-PAD in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber

Study Identifier:
CP002
CT.gov Identifier:
NCT00729508
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Study Complete

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Study Summary

To investigate the efficacy of 4 treatment regimens of Cat-PAD in cat allergic subjects following challenge to cat allergen in an environmental exposure chamber (EEC).

To evaluate safety and relationship between dose, dosing regimen and symptom scores in cat allergic subjects with rhinoconjunctivitis 17-21weeks(wk) after starting treatment using a standardized allergen challenge in an Environmental Exposure Chamber (EEC).

Outcomes:

Clinical efficacy was assessed by measurement of changes in Total Rhinoconjunctivitis Symptom Score (TRSS) during EEC visits. Safety was assessed by observing subjects in the clinic for 1 hour on each dosing day and capturing adverse events (AE) by direct questioning of subjects at every visit.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Prostate
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    II
    Sex
    Female & Male
    Age
    18 - 65 Years
    Study Drug
  • Drug: 24 subjects will be randomised into each treatment arm. Each subject will undergo screening up to 4 weeks before treatment. Baseline challenge will consist of exposure to cat allergen for 3 hours in an EEC on 4 visits on successive days a week before the first administration of Cat-PAD or placebo. Treatment will be administered as intradermal injections into the flexor surface of alternate forearms.
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  • Drug: Number of arms
  • Drug: Post-treatment challenge (PTC) will consist of exposure to cat allergen for 3 hours in an EEC on 4 visits on successive days 18 weeks after the first administration of Cat-PAD.
  • Drug: During the study, patients will receive a controlled dose of cat allergen in an environmental exposure chamber both before and after treatment, and will then complete a questionnaire to score their allergic rhinitis symptoms. This will allow investigators to evaluate the impact of the different treatment regimes.
  • Drug: WAO 2012:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    Inclusion criteria
    • Ages Eligible for Study
    • 18 Years to 65 Years
    • Inclusion Criteria
    • * Minimum 1-year documented history of rhinoconjunctivitis (Nasal symptoms: sneezing, itching, rhinorrhoea, blockage; Ocular symptoms: itching, redness, soreness, watering) on exposure to cats. [Subjects may also have controlled asthma (GINA classification 1)].
    • * Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control.
    • * Subjects must achieve minimum qualifying symptom scores on at least one Symptom Diary Card during EEC exposure on the third and fourth day during the Baseline Challenge. Minimum qualifying symptom scores are defined as a TRSS of at least 10 out of a possible 24 and a TNSS of at least 6 out of a possible 12.
    Exclusion criteria
    • Exclusion Criteria
    • * Subjects with asthma falling under GINA classification 2 (partly controlled) and 3 (uncontrolled).
    • * A history of anaphylaxis to cat allergen.
    • * Subjects with a cat specific IgE >100 kU/L.
    • * Subjects with an FEV1 < 80% of predicted.
    • * Subjects with an acute phase skin response to cat allergen with a mean wheal diameter > 50mm.
    • * Subjects who suffer from seasonal allergic rhinoconjunctivitis, and cannot complete the clinical study outside the local pollen season or who have significant allergy to other animal dander that cannot be avoided during the study period.
    • * Subjects who cannot tolerate baseline challenge in the EEC.
    • * Allergen immunotherapy during the last 12 months or any history of Cat Dander immunotherapy.
    • * Subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
    • * Subjects being treated with beta-blockers.
    • * History of immunopathological diseases.
    • * Positive test for Hepatitis B, Hepatitis C or HIV at screening.
    • * Have a history of severe drug allergy or anaphylactic reaction to food.
    • * A known allergy to thioglycerol.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Robert Jansen
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Prostate