Study of Dust Mite Inhalation in Humans

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David B. Peden, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00448851
First received: March 15, 2007
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

The purpose of this research study is to learn more about the effect of inhaled dust mite allergen extract on airway responses in allergic individuals with mild asthma. Information learned from this study will be used to identify a safe dose range of D Farinae extract for use in inhalation challenge studies. This study will also help determine how inhalation of the allergen affects mucociliary clearance (MCC) which is a measure of how quickly mucus clears from the airway.


Condition Intervention Phase
Mild Asthma
Allergy
Biological: inhaled allergen challenge
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Phase 1 Study of Dermatophagoides Farinae Inhalation in Humans

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Effect of allergen challenge procedure on the following:changes in airway monocytes cell surface marker expression and changes in airway PMN and Eosinophil numbers [ Time Frame: 0-24 hours post challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in symptom scores [ Time Frame: day 0 through day 4 post challenge ] [ Designated as safety issue: Yes ]
  • changes lung function [ Time Frame: 0-24 hours post challenge ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: February 2007
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
inhaled allergen challenge
Biological: inhaled allergen challenge
Subjects will inhale gradually increasing concentrations of Dermatophagoides farinae until a 15% drop in FEV1 is noted
Other Name: dust mites

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A history of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma.
  2. Specific allergy to house dust mite Dermatophagoides farinae confirmed by positive immediate skin test response.
  3. Provocative concentration of methacholine of 10 mg/ml or less producing a 20% fall in FEV1 (PC20 methacholine) by the method used in a separate screening protocol (98-CEMLB-293) that is already approved by the UNC IRB.
  4. FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with mild episodic or mild persistent asthma.

Exclusion Criteria:

  1. Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease.
  2. Subjects with a history of immunologic disease, or undergoing therapeutic immune suppression for cancer or other diseases.
  3. Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
  4. Use of systemic steroid therapy within the preceding 12 months for asthma or the following asthma symptoms; cough, wheeze, shortness of breath.
  5. Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or Zafirlukast) within the past month (except for use of cromolyn exclusively prior to exercise).
  6. Use of daily theophylline within the past month.
  7. Use of medications that might alter the response to methacholine or antigen challenge including anti-inflammatory and anti-histamine agents within one week of challenge.
  8. Subjects using tricyclic antidepressants such as doxepin and MAO inhibitors.
  9. Subjects using beta-adrenergic blockers or any other medications known to interfere with the treatment of anaphylaxis.
  10. Inability to withhold inhaled or oral bronchodilating medications for 12 hours prior to allergen challenge.
  11. Pregnancy (positive urine pregnancy test at the baseline visit) or nursing a baby. Pregnant women are excluded due to the risk of fetal exposure to radiation.
  12. Women of child bearing potential who are not using dependable contraception (such as birth control pill, IUD, estrogen patches) or who are not completely abstinent.
  13. Cigarette smoking >0.5 packs per week within the past 12 months.
  14. Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
  15. Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
  16. Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise).
  17. Viral upper respiratory tract infection within 4 weeks of challenge.
  18. Any acute infection requiring antibiotics within 2 weeks of challenge (or 4 weeks in the case of azithromycin due to the prolonged half-life).
  19. Participating in any study utilizing an investigational agent within 4 weeks of this challenge.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448851

Locations
United States, North Carolina
UNC Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, United States, 27599-7310
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: David B Peden, MD, MS University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David B. Peden, MD, Professor of Pediatrics, Director of CEMALB, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00448851     History of Changes
Other Study ID Numbers: 06-0528, NHLBI-RO1 HL080337
Study First Received: March 15, 2007
Last Updated: December 9, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
asthma
allergy

ClinicalTrials.gov processed this record on September 18, 2014