Airway Temperature

Withdrawn before enrolling · Phase 1

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT02401074

Run by

Lu Yuan Lee

People needed

0

Starts

2018-11-08

Expected to finish

2020-06-01

Last updated by the study team

2020-12-09

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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.

Where it is running

• University of Kentucky Medical Center, Center for Clinical and Translational Science — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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