Cat-PAD Exposure Chamber Study

NCT01033344 | Completed Phase 2

• 1 other identifier: CP005
• Study Type: interventional
• Target: 210
• 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 look at the efficacy, safety and tolerability of two doses of Cat-PAD in cat allergic subjects following challenge to cat allergen in an EEC.

Conditions

Cat Allergy

Keywords

Cat allergy; Rhinoconjunctivitis; Exposure chamber; Immunotherapy; Cat-PAD

Outcome Measures

Primary Outcomes (1)

• Total Rhinoconjunctivitis Symptom Score

  0 and 18-22 weeks after start of treatment

Secondary Outcomes (4)

• Symptom scores for ocular and nasal symptoms

  0 and 18-22 weeks after start of treatment

• Acoustic Rhinometry

  0 and 18-22 weeks after start of treatment

• Cat Specific IgE

  At 0 weeks and at follow up

• Adverse Events

  During study

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Solution resembling active solution but without peptides

Biological: Placebo

Group 1

EXPERIMENTAL

Cat-PAD dose group 1

Biological: Cat-PAD

Group 2

EXPERIMENTAL

Cat-PAD Dose group 2

Biological: Cat-PAD

Interventions

Placebo BIOLOGICAL

Intradermal injection 1x8 administrations 2 weeks apart

Placebo

Cat-PAD BIOLOGICAL

Intradermal injection 1x8 administrations 2 weeks apart

Group 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:

• Male or female, aged 18-65 years
• Minimum 1-year history of rhinoconjunctivitis on exposure to cats. (Subjects may also have controlled asthma)
• Positive skin prick test to cat allergen with a wheal diameter at least 3mm larger than that produced by the negative control
• Minimum qualifying rhinoconjunctivitis symptom scores

You may not qualify if:

• "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)

Sponsors & Collaborators

• Circassia Limited: lead
• Adiga Life Sciences, Inc.: collaborator
• Cetero Research, San Antonio: collaborator

Study Sites (1)

Cetero Research

Mississauga, Ontario, L4W 1N2, Canada

Location

Study Officials

• Deepen Patel, MD, CCF

  Cetero Research, San Antonio

  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: December 15, 2009
• First Posted: December 16, 2009
• Study Start: January 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 1, 2010

Record last verified: 2010-09

Locations

CA (1)