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Airway Temperature

NCT02401074 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-12-09

No results posted yet for this study

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.

Conditions

  • Asthma

Interventions

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)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Lu Yuan Lee

    lead OTHER

Principal Investigators

  • Lu Yuan Lee, PhD · University of Kentucky

  • Mehdi Khosravi, MD · University of Kentucky

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-08
Primary Completion
2020-06-30
Completion
2020-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02401074 on ClinicalTrials.gov