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Airway Temperature (RATE)

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ClinicalTrials.gov Identifier: NCT02401074
Recruitment Status : Not yet recruiting
First Posted : March 27, 2015
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Lu Yuan Lee, University of Kentucky

Brief Summary:
Airway irritation, cough and bronchial spasm are common symptoms in patients with airway inflammatory diseases such as asthma. The primary focus of this exploratory study is to determine if there is an increase in tissue temperature in airway mucosa during asthma exacerbation. The results of this study will bring a better understanding of the potential involvement of an increase in airway mucosa temperature in the pathogenesis of various symptoms in these patients. The finding should help to advance the development of new therapeutic strategies for these debilitating diseases.

Condition or disease Intervention/treatment Phase
Asthma Biological: Segmental Bronchoprovocation with Allergen (SBP-Ag) Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Role of Airway Tissue Temperature in Asthma Exacerbation
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Segmental bronchoprovocation with Allergen (SBP-Ag)
Following nasopharyngeal anesthesia, the fiberoptic bronchoscope will then be passed into a pulmonary segment or subsegment. During SBP-Ag challenge, 15% of the Ag-PD20 allergenic extract will be instilled into the segment.
Biological: Segmental Bronchoprovocation with Allergen (SBP-Ag)
Premedication will consist of intramuscular glycopyrolate (0.2 mg), and midazolam (0.5-2.0 mg). Subjects will also be given a short-acting beta agonist, albuterol (2 puffs, 180 mcg) prior to bronchoscopy. Following nasopharyngeal anesthesia (topical lidocaine), the fiberoptic bronchoscope will then be passed into a pulmonary segment or subsegment. During the SBP-Ag challenge, approximately 15% of the Ag-PD20 allergenic extract will be instilled into the segment (5)




Primary Outcome Measures :
  1. Airway tissue temperature [ Time Frame: Immediately during experimental procedure (up to 10 minutes) ]
    Direct measurements of the airway mucosal temperature will be performed before and at ten minutes after the SBP-Ag challenge. By maneuvering the control knob of the bronchoscope, the blunted tip of the probe will be gently pressed against the airway mucosa at 5-6 different positions in segmental and sub-segmental bronchi, each for five to ten seconds. The entire protocol of the temperature measurement will require no more than 5 minutes to complete.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-60 years of age
  • Diagnosis of well-controlled airway allergy with mild-intermittent asthma (a stable clinical condition with good asthma control) and demonstrating an allergen-specific airway response to inhaled allergen provocation.
  • Pre-albuterol forced expiratory volume in the first second (FEV1) of >70% of the predicted value.
  • Skin test positive to house dust mite, ragweed or cat hair.
  • At least a 20% decrease in FEV1 during the immediate response following inhaled antigen challenge.
  • Competent to understand and willing to grant written informed consent.

Exclusion Criteria:

  • Inability to perform pulmonary function testing.
  • History of any lung disease or disorder other than asthma.
  • Major health problems such as autoimmune disease, heart disease, coronary artery disease, type I or type II diabetes, or uncontrolled hypertension.
  • Pre-existing chronic infectious disease.
  • Medication that is taken for other than for asthma, allergies or contraception.
  • Inhaled corticosteroids or oral corticosteroids within 1 month of screening.
  • Upper and lower respiratory infection within 1 month of screening.
  • Unstable asthma as indicated by self report of increased symptoms or increased beta-agonist use over the 2 weeks preceding the screening visit.
  • Pregnant or lactating females.
  • History of smoking.
  • History of noncompliance with medical regiments or subjects who are considered unreliable.
  • Use of anti-platelet (i.e., aspirin, clopidogrel, etc) or anti-coagulant(coumadin, heparin, Xarelto®, etc) medication 5 days prior to bronchoscopy.

It is required that the subjects undergoing bronchoscopy are not on any anti-platelets (such as aspirin, clopidogrel, etc.) or anticoagulants (such as coumadin, heparin, Xarelto®, etc.) at least 5 days prior to the bronchoscopy. As such, subjects receiving any of these medications will be excluded from the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401074


Contacts
Contact: Dianne Richeson 859-323-2093 dmri223@uky.edu

Sponsors and Collaborators
Lu Yuan Lee
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Lu Yuan Lee, PhD University of Kentucky
Principal Investigator: Mehdi Khosravi, MD University of Kentucky

Responsible Party: Lu Yuan Lee, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT02401074     History of Changes
Other Study ID Numbers: IND 16362
U01AI123832 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases