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Phase III Cat-PAD Study

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ClinicalTrials.gov Identifier: NCT01620762
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : July 28, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Rhinoconjunctivitis Drug: Cat-PAD Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1408 participants
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
Study Start Date : October 2012
Primary Completion Date : June 2016
Arms and Interventions

Arm Intervention/treatment
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
Drug: Placebo
1 dose every 4 weeks

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Symptom Scores [ Time Frame: up to 52 weeks after randomisation ]
    Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects

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

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

Eligibility Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620762

  Show 118 Study Locations
Sponsors and Collaborators
Circassia Limited
inVentiv Health Clinical
Pharm-Olam International
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
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Keywords provided by Circassia Limited:
Cat allergy

Additional relevant MeSH terms:
Conjunctival Diseases
Eye Diseases