A Study of Inhalation of 20,000 EU CCRE in Normal Volunteers Compared to Allergic Asthmatic Individuals (Endomac)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00839124
First received: February 6, 2009
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

This will be a single center, open label study comparing baseline characteristics of recovered sputum cells (collected on screening day) to those of cells recovered 6 hours after inhalational challenge with 20,000 EU Clinical Center Reference Endotoxin (CCRE, a component of air pollution)) within each group as well as cross group comparisons between individuals with allergic asthma (AA's)and normal volunteers (NV's). The primary objective of this study is to test the hypothesis that persons with allergic asthma will have an increased neutrophil response to challenge with 20,000 EU CCRE compared to normal volunteers. Secondary objectives include post CCRE comparison between AA's and NV's with regard to changes in airway cells and blood as well as changes in mucociliary clearance (MCC) in response to inhalation of 20,000 EU CCRE.


Condition Intervention Phase
Asthma
Hypersensitivity
Biological: Clinical Center Reference Endotoxin (CCRE)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Study of Inhalation of 20,000 EU Clinical Center Reference Endotoxin in Normal Volunteers Compared to Allergic Asthmatic Individuals

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The primary objective of this study is to test the hypothesis that persons with allergic asthma will have an increased neutrophil response to challenge with 20,000 EU CCRE compared to normal volunteers [ Time Frame: 6 hours post challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary objectives include post CCRE comparison between AA's and NV's with regard to changes in airway cells and blood as well as changes in mucociliary clearance (MCC) in response to inhalation of 20,000 EU CCRE. [ Time Frame: 6-24 hours post challenge ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: January 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Allergic asthma
subjects with allergic asthma will undergo challenge with 20,000 EU CCRE
Biological: Clinical Center Reference Endotoxin (CCRE)
inhalation of 20,000 EU CCRE
Other Name: air pollution
Active Comparator: healthy control
Healthy volunteers will undergo challenge with 20,000 EU CCRE
Biological: Clinical Center Reference Endotoxin (CCRE)
inhalation challenge with 20,000 EU CCRE
Other Name: air pollution

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for healthy controls:

  • Normal lung function, defined as (Knudson 1976/1984 predicted set):

FVC of > 80 % of that predicted for gender, ethnicity, age and height FEV1 of > 80 % of that predicted for gender, ethnicity, age and height FEV1/FVC ratio of > .75

  • Oxygen saturation of > 94 % and normal blood pressure (Systolic between 150 - 90, Diastolic between 90-60 mm Hg)
  • Symptom Score no greater than 6 (out of a possible 24) for total symptom score with a value no greater than 2 for any one score.
  • Negative methacholine inhalation challenge as performed in the screening protocol. (Less than a 20% decrease in FEV1 at a maximum methacholine concentration of 10 mg/ml)

    --Negative pregnancy test for females

  • Negative allergy skin test (AST)

Inclusion criteria for allergic asthmatics also include:

  • History of episodic wheezing, chest tightness, or shortness of breath after age of 6 years consistent with asthma, or physician diagnosed asthma after age of 6 years.
  • Positive methacholine test.
  • FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of bronchodilating medications for 12 hours)
  • Allergic sensitization to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive AST.
  • Negative allergy skin test as performed in the screening protocol.

Exclusion Criteria:

  • 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.
  • Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
  • Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician.
  • Use of inhaled steroids, cromolyn or leukotriene inhibitors (montelukast or zafirlukast) except for use of cromolyn exclusively prior to exercise.
  • Use of daily theophylline within the past month.
  • Use of tricyclics and MAO inhibitors
  • Pregnancy or nursing a baby.
  • Cigarette smoking > 1 pack per month.
  • 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.
  • 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).
  • Viral upper respiratory tract infection within 2 weeks of challenge.
  • Any acute infection requiring antibiotics within 2 weeks of challenge
  • Receipt of LAIV (Live Attenuated Influenza Vaccine), also know as FluMist®, within the prior 14 days
  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: NCT00839124

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: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00839124     History of Changes
Other Study ID Numbers: 08-1750 (CTRC # 2776), 5 U19 AI077437-02
Study First Received: February 6, 2009
Last Updated: December 4, 2012
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:
normal volunteer
healthy control volunteer
healthy subjects
asthma
allergy
allergic asthma

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014