search
Back to results

Effect of Pollen Challenges on Dermal Symptoms in Patients With Atopic Dermatitis (Neurop)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Grass pollen : Dactylis glomerata
Challenge with clean air
Sponsored by
Fraunhofer-Institute of Toxicology and Experimental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female subjects, aged 18-65 years. Women will be considered for inclusion if they are: Not pregnant, as confirmed by pregnancy test (see flow chart) and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit). Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after the last pollen challenge -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
  • Positive IgE level for Dactylis glomerata of at least CAP FEIA class 3.
  • atopic dermatitis (AD) fulfilling the UK criteria of AD
  • SCORAD between 20 and 50 points.
  • forced Expiratory Volume in the first second (FEV1) ≥ 80% pred. at screening.
  • Smokers or non-smokers.
  • Body Mass Index ≥18 and ≤ 35.

Exclusion Criteria:

  • • Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease.
  • Asthma other than mild asthma which is treated with short acting beta-2-agonists only and which is controlled according to the current GINA guidelines
  • Clinically relevant abnormalities in haematology, blood chemistry, or urinalysis at screening.
  • Positive HIV-1/2Ab, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCV-Ab) test at screening.
  • Treatment with medication that might interfere with rescue medication for anaphylactic reactions (e.g. beta blocker).
  • Topical steroid treatment (wash out phase: 2 weeks)
  • Topical calcineurin inhibitor treatment (wash out phase 2 weeks)
  • UV radiation treatment (wash out phase 4 weeks)
  • Systemic immunosuppression treatment (steroids, cyclosporine, azathioprine, Mycophenolat Mofetil (MMF); wash out phase 4 weeks)
  • Treatment with antihistamines (wash out phase 1 week)
  • Unstable AD during Screening (SCORAD difference of >10 points from Visit 1 to Visit 2)
  • Diastolic blood pressure above 95 mmHg.
  • Febrile illness within 2 weeks prior to screening.
  • Alcohol or drug abuse within 12 month prior to screening.
  • Regular daily consumption of more than 1 liter of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form.
  • Participation in another clinical trial 30 days prior to enrolment.
  • There is a risk of non-compliance with study procedures.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Challenge with grass pollen

    Challenge with clean air

    Arm Description

    Outcomes

    Primary Outcome Measures

    SCORAD
    Change in SCORAD between Day 1/ baseline (assessed 60 minutes prior to challenge) and Day 3 (assessed post-challenge)

    Secondary Outcome Measures

    SCORAD Day 4 and 5
    Change in SCORAD between Day 1 (assessed 60 minutes prior to challenge) and the Scorad on Day 4 and Day 5 (assessed post challenge).

    Full Information

    First Posted
    November 4, 2011
    Last Updated
    April 4, 2012
    Sponsor
    Fraunhofer-Institute of Toxicology and Experimental Medicine
    Collaborators
    Hannover Medical School
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01475994
    Brief Title
    Effect of Pollen Challenges on Dermal Symptoms in Patients With Atopic Dermatitis
    Acronym
    Neurop
    Official Title
    Pilot Study to Assess the Effect of Pollen Challenges in an Environmental Challenge Chamber on Dermal Symptoms in Patients With Atopic Dermatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    April 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fraunhofer-Institute of Toxicology and Experimental Medicine
    Collaborators
    Hannover Medical School

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a mono-center, randomized, double-blind, placebo-controlled, parallel-group study to assess the effect of challenges with dactylis glomerata pollen in an environmental challenge chamber on dermal symptoms in patients suffering from atopic dermatitis. After each challenge session and on Day 3, Day 4, and Day 5 blood samples will be taken for biomarker assessments. The severity of atopic dermatitis will be rated with the "SCORing Atopic Dermatitis" (SCORAD), with the objective SCORAD and with the assessment of itch and sleeplessness referring to the past 24 hours by a blinded observer (trained dermatologist) on each day including baseline assessments.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atopic Dermatitis

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Challenge with grass pollen
    Arm Type
    Experimental
    Arm Title
    Challenge with clean air
    Arm Type
    Placebo Comparator
    Intervention Type
    Other
    Intervention Name(s)
    Grass pollen : Dactylis glomerata
    Intervention Description
    The subjects will be challenged for 4 hours on two consecutive days (Day 1 and Day 2) with either 4000 pollen grains/m3 of dactylis glomerata pollen.
    Intervention Type
    Other
    Intervention Name(s)
    Challenge with clean air
    Intervention Description
    The subjects will be challenged for 4 hours on two consecutive days (Day 1 and Day 2) with clean air.
    Primary Outcome Measure Information:
    Title
    SCORAD
    Description
    Change in SCORAD between Day 1/ baseline (assessed 60 minutes prior to challenge) and Day 3 (assessed post-challenge)
    Time Frame
    Day 1/Baseline vs. Day 3
    Secondary Outcome Measure Information:
    Title
    SCORAD Day 4 and 5
    Description
    Change in SCORAD between Day 1 (assessed 60 minutes prior to challenge) and the Scorad on Day 4 and Day 5 (assessed post challenge).
    Time Frame
    Day 1/Baseline vs. Day 4 and 5

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male and female subjects, aged 18-65 years. Women will be considered for inclusion if they are: Not pregnant, as confirmed by pregnancy test (see flow chart) and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit). Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after the last pollen challenge -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap). Positive IgE level for Dactylis glomerata of at least CAP FEIA class 3. atopic dermatitis (AD) fulfilling the UK criteria of AD SCORAD between 20 and 50 points. forced Expiratory Volume in the first second (FEV1) ≥ 80% pred. at screening. Smokers or non-smokers. Body Mass Index ≥18 and ≤ 35. Exclusion Criteria: • Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease. Asthma other than mild asthma which is treated with short acting beta-2-agonists only and which is controlled according to the current GINA guidelines Clinically relevant abnormalities in haematology, blood chemistry, or urinalysis at screening. Positive HIV-1/2Ab, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HCV-Ab) test at screening. Treatment with medication that might interfere with rescue medication for anaphylactic reactions (e.g. beta blocker). Topical steroid treatment (wash out phase: 2 weeks) Topical calcineurin inhibitor treatment (wash out phase 2 weeks) UV radiation treatment (wash out phase 4 weeks) Systemic immunosuppression treatment (steroids, cyclosporine, azathioprine, Mycophenolat Mofetil (MMF); wash out phase 4 weeks) Treatment with antihistamines (wash out phase 1 week) Unstable AD during Screening (SCORAD difference of >10 points from Visit 1 to Visit 2) Diastolic blood pressure above 95 mmHg. Febrile illness within 2 weeks prior to screening. Alcohol or drug abuse within 12 month prior to screening. Regular daily consumption of more than 1 liter of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form. Participation in another clinical trial 30 days prior to enrolment. There is a risk of non-compliance with study procedures.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jens Hohlfeld, MD, professor
    Organizational Affiliation
    Fraunhofer Gesellschaft
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Pollen Challenges on Dermal Symptoms in Patients With Atopic Dermatitis

    We'll reach out to this number within 24 hrs