Eicosanoid Lipids by Airway Cells During Infection With Human Rhinoviruses

NCT01898767 | Completed DMC

• 2 other identifiers: 2013-09351R01HL115118-01A1
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The long-range goal of this protocol is to more completely understand the risks and the pathophysiology of asthma exacerbations, in order to develop prevention strategies and/or expedite a return to complete control of baseline asthma symptoms.

Conditions

Asthma

Keywords

mild; asthma; allergic

Outcome Measures

Primary Outcomes (3)

• Cox2 expression

  P2X7 agonist-induced fold stimulation (over the media control) of cox2 expression (assessed by densitometry) in alveolar macrophages primed with conditioned medium from minor group HRV-infected epithelial cells.

  One day

• BzATP-induced PGE2

  The amount of BzATP-induced PGE2 in the culture supernatants of alveolar macrophages primed with HRV-infected epithelial conditioned media

  One day

• LXA4 produced by BzATP

  The amount of LXA4 produced by BzATP co-treatment of HRV infected of epithelial-macrophage co-cultures.

  One day

Study Arms (1)

Mild asthma

Diagnosis of mild asthma as defined by pre-albuterol forced expiratory volume in the first second (FEV1) of \>70% predicted.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with mild asthma from Madison, WI region

You may qualify if:

• Age 18-55 years
• Diagnosis of mild asthma
• Pre-albuterol forced expiratory volume in the first second (FEV1) of \>70% predicted.
• Confirmation of asthma diagnosis by either an improvement in FEV1 after four puffs of albuterol by ≥ 12%, or a decline in FEV1 by ≥ 20% after a graded challenge with inhaled methacholine with a provocative concentration causing a 20% fall ≤ 8 mg/mL
• Documented negative Tuberculin skin test (PPD) within the last 12 months or a medical history that is consistent with a low probability of exposure to tuberculosis (i.e. the subject is not a health worker, has not traveled to endemic areas, and has no pre-existing medical or social risk factors for tuberculosis).
• Safety laboratory assessments within normal ranges (labs to include complete blood count with differential and platelet count, PT/INR, creatinine, ALT)
• Women of child-bearing potential (WCBP) must have a negative urine pregnancy test (urine HCG) within 48 hours of the methacholine challenge at Visit 2, within 48 hours of the bronchoscopy at Visit 3 and within 48 hrs of Visit 4. WCBP must agree to use a reliable method of birth control for the duration of the study (reliable methods of birth control can include abstinence, barrier methods, oral contraceptives, injection contraceptives or skin absorption contraceptives).
• In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements.

You may not qualify if:

• No pre-existing chronic infectious disease.
• Any condition for which, in the opinion of the investigator, transient oxyhemoglobin desaturation is inadvisable.
• Pregnant or lactating females or has a planned pregnancy during the course of the study.
• Asthma maintenance therapy other than inhaled short acting beta-agonists within 1 month of screening. This includes but is not limited to inhaled or oral corticosteroids, long acting beta-agonists and leukotriene receptor antagonists.
• Upper or 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.
• Current smokers (defined as smoked within the last year) or a former smoker with a history of \>10 pack years.
• Morbid obesity as defined by a Body Mass Index (BMI) \> 40.
• Use of an investigational drug within 30 days of entering the study
• History of noncompliance with medical regiments or subjects who are considered unreliable including those with a psychiatric history that, in the opinion of the investigator, may interfere with the conduct of study procedures.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UW Madison

Madison, Wisconsin, 53792, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma, DNA, RNA, bronchoalveolar lavage, bronchial brushings

MeSH Terms

Conditions

Asthma; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Study Officials

• Loren Denlinger, MD/PhD

  UW Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 12, 2013
• Study Start: December 17, 2013
• Primary Completion: August 29, 2017
• Study Completion: August 29, 2017
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)