Airway Temperature

NCT02401074 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: IND 16362U01AI123832
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Airway tissue temperature

  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.

  Immediately during experimental procedure (up to 10 minutes)

Study Arms (1)

Segmental bronchoprovocation with Allergen (SBP-Ag)

EXPERIMENTAL

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)

Interventions

Segmental Bronchoprovocation with Allergen (SBP-Ag) BIOLOGICAL

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)

Segmental bronchoprovocation with Allergen (SBP-Ag)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lu Yuan Lee: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Kentucky Medical Center, Center for Clinical and Translational Science

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Allergens

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

Study Officials

• Lu Yuan Lee, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Mehdi Khosravi, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: March 27, 2015
• Study Start: November 8, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)