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

This study has been completed.
Sponsor:
Collaborator:
Hannover Medical School
Information provided by (Responsible Party):
Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT01475994
First received: November 4, 2011
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Atopic Dermatitis
Other: Grass pollen : Dactylis glomerata
Other: Challenge with clean air

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Pilot Study to Assess the Effect of Pollen Challenges in an Environmental Challenge Chamber on Dermal Symptoms in Patients With Atopic Dermatitis

Further study details as provided by Fraunhofer-Institute of Toxicology and Experimental Medicine:

Primary Outcome Measures:
  • SCORAD [ Time Frame: Day 1/Baseline vs. Day 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1/Baseline vs. Day 4 and 5 ] [ Designated as safety issue: No ]
    Change in SCORAD between Day 1 (assessed 60 minutes prior to challenge) and the Scorad on Day 4 and Day 5 (assessed post challenge).


Enrollment: 18
Study Start Date: November 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Challenge with grass pollen Other: Grass pollen : Dactylis glomerata
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.
Placebo Comparator: Challenge with clean air Other: Challenge with clean air
The subjects will be challenged for 4 hours on two consecutive days (Day 1 and Day 2) with clean air.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01475994

Sponsors and Collaborators
Fraunhofer-Institute of Toxicology and Experimental Medicine
Hannover Medical School
Investigators
Principal Investigator: Jens Hohlfeld, MD, professor Fraunhofer Gesellschaft
  More Information

No publications provided

Responsible Party: Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier: NCT01475994     History of Changes
Other Study ID Numbers: 11-01 Neurop
Study First Received: November 4, 2011
Last Updated: April 4, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 27, 2014