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

NCT01475994 | Completed

• 1 other identifier: 11-01 Neurop
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• SCORAD

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

  Day 1/Baseline vs. Day 3

Secondary Outcomes (1)

• SCORAD Day 4 and 5

  Day 1/Baseline vs. Day 4 and 5

Study Arms (2)

Challenge with grass pollen

EXPERIMENTAL

Other: Grass pollen : Dactylis glomerata

Challenge with clean air

PLACEBO COMPARATOR

Other: Challenge with clean air

Interventions

Grass pollen : Dactylis glomerata OTHER

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.

Challenge with grass pollen

Challenge with clean air OTHER

The subjects will be challenged for 4 hours on two consecutive days (Day 1 and Day 2) with clean air.

Challenge with clean air

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fraunhofer-Institute of Toxicology and Experimental Medicine: lead
• Hannover Medical School: collaborator

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jens Hohlfeld, MD, professor

  The Fraunhofer-Gesellschaft

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: November 22, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 5, 2012

Record last verified: 2012-04