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Phase III Cat-PAD Study

This study has been completed.
Sponsor:
Collaborators:
inVentiv Health Clinical
Pharm-Olam International
Information provided by (Responsible Party):
Circassia Limited
ClinicalTrials.gov Identifier:
NCT01620762
First received: May 30, 2012
Last updated: July 26, 2017
Last verified: July 2017
  Purpose
The purpose of this study is to compare the treatment effect of two treatment regimens of Cat-PAD vs placebo and to evaluates the treatment effect of Cat-PAD on symptoms, rescue medication usage and Quality of Life.

Condition Intervention Phase
Rhinoconjunctivitis Drug: Cat-PAD Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomised, Placebo-Controlled Multi-Centre Field Study to Assess the Efficacy and Safety of Cat-PAD Peptide Immunotherapy in Cat Allergic Subjects

Further study details as provided by Circassia Limited:

Primary Outcome Measures:
  • Combined Score of symptoms and allergy medication [ Time Frame: up to 52 weeks after randomisation ]
    Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication


Secondary Outcome Measures:
  • Symptom Scores [ Time Frame: up to 52 weeks after randomisation ]
    Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects

  • Rescue Medication Use [ Time Frame: up to 52 weeks after randomisation ]
    Use of allergy medication to help allergy symptoms

  • Quality of Life [ Time Frame: up to 52 weeks after randomisation ]
  • Incidence and frequency of Adverse Events [ Time Frame: up to 52 weeks after randomisation ]

Enrollment: 1408
Study Start Date: October 2012
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cat-Pad Treatment 1
Cat-PAD Treatment 1
Drug: Cat-PAD
1 dose every 4 weeks
Experimental: Cat-PAD Treatment 2
Cat-PAD Treatment regimen 2
Drug: Cat-PAD
1 dose every 4 weeks
Drug: Placebo
1 dose every 4 weeks
Placebo Comparator: Placebo
Placebo
Drug: Placebo
1 dose every 4 weeks

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Male or female, aged 12-65 years.
  • Moderate to severe rhinoconjunctivitis on exposure to cats for at least 2 years.
  • Subjects may optionally also have GINA Step 1 controlled asthma.
  • Positive skin prick test to cat hair.
  • Cat dander specific IgE ≥0.35 kU/L.

Exclusion Criteria

  • Asthma falling under the GINA definitions "partly controlled" and "uncontrolled" or Steps 2 to 5.
  • FEV1 <80% of predicted.
  • Clinically significant confounding symptoms of allergy to seasonal allergens during the final evaluation period.
  • Skin prick test 5 mm greater than the negative control to perennial allergens or animal dander (other than cat) which cannot be avoided during the study.
  • Significant symptoms of another clinically relevant illness that is likely to affect scoring of rhinoconjunctivitis symptoms.
  • Clinically relevant abnormalities detected on physical examination.
  • History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620762

  Show 118 Study Locations
Sponsors and Collaborators
Circassia Limited
inVentiv Health Clinical
Pharm-Olam International
Investigators
Principal Investigator: Harold Nelson, MD Jewish National Health
  More Information

Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT01620762     History of Changes
Other Study ID Numbers: CP007
Study First Received: May 30, 2012
Last Updated: July 26, 2017

Keywords provided by Circassia Limited:
Cat allergy
Rhinoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 18, 2017