Effectiveness of Cat-PAD to Treat Cat Allergy in Cat Allergic Subjects

NCT00729508 | Completed Phase 2

• 1 other identifier: CP002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy. This study will 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).

Conditions

Cat Allergy

Keywords

Cat allergy; Immunotherapy; Cat-PAD; Environmental Exposure Chamber

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Total Rhinoconjunctivitis Symptom Score (TRSS) using all timepoints during PTC in Cat-PAD treatment groups compared to placebo.

  18 weeks

Secondary Outcomes (6)

• Change from baseline in TRSS in Cat-PAD treatment groups at last two timepoints on third and fourth challenge days compared to placebo.

  18 weeks

• Change from baseline in individual symptom scores for ocular and nasal symptoms at all timepoints during Exposure Chamber visit in Cat-PAD treatment groups compared to placebo.

  18 weeks

• Change from baseline in TRSS at all timepoints during Exposure Chamber visit in pooled data from Cat-PAD treatment groups compared to placebo.

  18 weeks

• Proportion of subjects prematurely leaving the EEC due to intolerable symptoms during Post-Treatment Challenge (PTC) in Cat-PAD treatment groups compared to placebo.

  18 weeks

• Change from baseline in EEC-Rhinoconjunctivitis Quality of Life Questionnaire (EEC-RQOL) at all timepoints during Exposure Chamber visit in Cat-PAD treatment groups compared to placebo.

  18 weeks

Study Arms (5)

1

EXPERIMENTAL

Biological: Cat-PAD

2

EXPERIMENTAL

Biological: Cat-PAD

3

EXPERIMENTAL

Biological: Cat-PAD

4

EXPERIMENTAL

Biological: Cat-PAD

5

PLACEBO COMPARATOR

Biological: Cat-PAD

Interventions

Cat-PAD BIOLOGICAL

Cat-PAD dose 2X 4 administrations 2 weeks apart

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Circassia Limited: lead

Study Sites (1)

Cetero Research

Toronto, Ontario, L4W 1N2, Canada

Location

Study Officials

• Deepen Patel, MD

  Allied Research International Inc-Cetero Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 4, 2008
• First Posted: August 7, 2008
• Study Start: August 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 8, 2009

Record last verified: 2009-07

Locations

CA (1)