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Phase III Cat-PAD Follow-on Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02040844
Recruitment Status : Completed
First Posted : January 20, 2014
Results First Posted : May 14, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Circassia Limited

Brief Summary:
The purpose of this study is to evaluate the continued effectiveness and safety of Cat-PAD in cat allergic subjects for up to five years after the start of administration of treatment. The study is an optional follow-up study to a phase III double-blind, placebo controlled, Cat-PAD study; no further investigational product is administered.

Condition or disease Intervention/treatment Phase
Cat Allergy Drug: Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762] Drug: Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762] Drug: Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762] Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Optional Prospective Follow-on Study to Evaluate the Continued Efficacy and Safety of Cat-PAD in Cat Allergic Subjects up to Five Years After the Administration of Treatment
Actual Study Start Date : February 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Cat-PAD Treatment 1
Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762].No further treatment received in CP007A
Drug: Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]
Cat-PAD Treatment 2
Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762].No further treatment received in CP007A.
Drug: Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]
Cat-PAD Treatment 3
Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]. No further treatment received in CP007A.
Drug: Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]



Primary Outcome Measures :
  1. Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS]) [ Time Frame: 1 year after completing CP007 ]

    The primary endpoint was the mean Combined Score (CS) in Cat-PAD treatment groups compared with the mean CS in the placebo group. This was assessed one year after completing the original study (CP007).

    CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Allergy Medication Score (AMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe) and the TRSS was divided by the number of symptoms to provide an average score per symptom of 0-3.

    AMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The AMS score was not additive, and therefore the maximum AMS was 3 and the maximum CS was 6.



Secondary Outcome Measures :
  1. Mean TRSS [ Time Frame: 1 year after completion of CP007 ]

    Mean Total Rhinoconjunctivitis Symptom Score (TRSS) in Cat-PAD treatment groups compared with placebo.

    Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome), therefore TRSS could range from 0 to 24. Higher TRSS reflected more severe symptom scores. Symptoms were scored daily for a period of approximately 3 weeks one year after completing the first study (CP007).


  2. Mean Component Scores of the TRSS (Nasal) [ Time Frame: 1 year after completion of CP007 ]

    TNSS (Total nasal symptom score) was the sum of all the nasal symptom scores (runny nose; sneezing; blocked nose; itchy nose) and could range from 0 to 12. Higher TNSS reflected more severe symptoms.

    Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks 1 year after completing the original CP007 study.


  3. Mean Component Scores of the TRSS (Ocular) [ Time Frame: 1 year after completion of CP007 ]

    Mean daily Total Ocular Symptom Score (TOSS) in Cat-PAD treatment groups compared to placebo groups

    Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. TOSS was the sum of all the ocular symptom scores (itchy eyes; watery eyes; red eyes; sore eyes) and could range from 0 to 12. Higher TOSS reflected more severe symptoms.

    Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks one year after completing the original CP007 study


  4. Mean Allergy Medication Score (AMS) [ Time Frame: 1 year after completion of CP007 ]

    Mean AMS (Allergy medication score) in Cat-PAD treatment groups compared with placebo groups.

    The use of rhinoconjunctivitis rescue medications was recorded by the subject for a period of 21 days, on a daily basis just before bedtime, approximately 1 year after completing the original CP007 study. Rescue medication use was scored based on a previously published system as follows: 0 = no allergy rescue medication used per day; 0.5 = at least one dose of antihistamine eye drops used per day; 1 = at least one dose of oral antihistamine used per day; 2 = at least one dose of intranasal corticosteroid used per day; 3 = at least one dose of systemic corticosteroid used per day. The score was according to the highest level of rescue medication used and was not additive.


  5. Mean RQLQ Score [ Time Frame: 1 year after completion of CP007 ]

    The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects one year after the completion of the previous study (CP007).

    The RQLQ is a validated method of assessing quality of life and has 28 questions in seven domains (activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems and emotional function). Subjects recalled how their rhinoconjunctivitis had been during the last week and responded to each question on a seven-point scale (0 = no impairment, 6 = maximum impairment). The questions were equally weighted, and the RQLQ score was the mean of the 28 questions and could range from zero to six.

    A higher score indicated greater impact on quality of life and thus a low score indicated a better outcome.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • previously completed clinical study CP007 [NCT01620762]

Exclusion Criteria:

  • started allergen therapy since completing CP007
  • Institutionalised due to a legal or regulatory order

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): NCT02040844


Sponsors and Collaborators
Circassia Limited
Investigators
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Principal Investigator: Jörg Kleine-Tebbe, MD Clinical Research Center for Dermatology, Allergy & Asthma
  Study Documents (Full-Text)

Documents provided by Circassia Limited:
Study Protocol  [PDF] December 8, 2014
Statistical Analysis Plan  [PDF] February 23, 2017

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Responsible Party: Circassia Limited
ClinicalTrials.gov Identifier: NCT02040844    
Other Study ID Numbers: CP007 A
First Posted: January 20, 2014    Key Record Dates
Results First Posted: May 14, 2018
Last Update Posted: June 15, 2018
Last Verified: May 2018