Study of Dust Mite Inhalation in Humans

NCT00448851 | Completed Phase 1

• 2 other identifiers: 06-0528NHLBI-RO1 HL080337
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Asthma; Allergy

Keywords

asthma; allergy

Outcome Measures

Primary Outcomes (1)

• Effect of allergen challenge procedure on the following:changes in airway monocytes cell surface marker expression and changes in airway PMN and Eosinophil numbers

  0-24 hours post challenge

Secondary Outcomes (2)

• changes in symptom scores

  day 0 through day 4 post challenge

• changes lung function

  0-24 hours post challenge

Study Arms (1)

1

EXPERIMENTAL

inhaled allergen challenge

Biological: inhaled allergen challenge

Interventions

inhaled allergen challenge BIOLOGICAL

Subjects will inhale gradually increasing concentrations of Dermatophagoides farinae until a 15% drop in FEV1 is noted

Also known as: dust mites

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A history of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma.
• Specific allergy to house dust mite Dermatophagoides farinae confirmed by positive immediate skin test response.
• 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.
• 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.

You may not qualify if:

• 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.
• Subjects with a history of immunologic disease, or undergoing therapeutic immune suppression for cancer or other diseases.
• Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
• Use of systemic steroid therapy within the preceding 12 months for asthma or the following asthma symptoms; cough, wheeze, shortness of breath.
• Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or Zafirlukast) within the past month (except for use of cromolyn exclusively prior to exercise).
• Use of daily theophylline within the past month.
• 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.
• Subjects using tricyclic antidepressants such as doxepin and MAO inhibitors.
• Subjects using beta-adrenergic blockers or any other medications known to interfere with the treatment of anaphylaxis.
• Inability to withhold inhaled or oral bronchodilating medications for 12 hours prior to allergen challenge.
• 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.
• 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.
• Cigarette smoking \>0.5 packs per week within the past 12 months.
• 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.
• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599-7310, United States

Location

Related Publications (1)

• Bennett WD, Herbst M, Alexis NE, Zeman KL, Wu J, Hernandez ML, Peden DB. Effect of inhaled dust mite allergen on regional particle deposition and mucociliary clearance in allergic asthmatics. Clin Exp Allergy. 2011 Dec;41(12):1719-28. doi: 10.1111/j.1365-2222.2011.03814.x. Epub 2011 Jul 5.

  PMID: 21729182 DERIVED

MeSH Terms

Conditions

Hypersensitivity; Asthma

Interventions

Antigens, Dermatophagoides

Condition Hierarchy (Ancestors)

Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

Study Officials

• David B Peden, MD, MS

  University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Director of CEMALB

Study Record Dates

• First Submitted: March 15, 2007
• First Posted: March 19, 2007
• Study Start: February 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 10, 2013

Record last verified: 2013-12

Locations

US (1)