A Prospective Observational Study of Biopredictors of Bronchial Thermoplasty Response in Patients With Severe Refractory Asthma (BTR Study)

NCT01185275 | Completed

• 1 other identifier: 10-0716- 201106118
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 8

Brief Summary

Clinical response, as defined by improvement in asthma quality of life, to bronchial thermoplasty in patients with severe refractory asthma can be predicted through the use of clinical, physiologic, biologic and imaging markers.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Baseline predictors of response to bronchial thermoplasty defined by improvement in asthma quality of life, in patients with severe refractory asthma.

  To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by improvement in asthma quality of life, in patients with severe refractory asthma.

  12 months following last bronchial thermoplasty treatment

Secondary Outcomes (4)

• Baseline predictors of severe exacerbations

  12 months following last bronchial thermoplasty treatment

• Baseline predictors of healthcare utilization

  12 months following last bronchial thermoplasty treatment

• Baseline predictors of safety of bronchial thermoplasty

  12 months following last bronchial thermoplasty treatment

• Predictive models of response to bronchial thermoplasty

  12 months following last bronchial thermoplasty treatment

Study Arms (1)

Severe Asthma Patients

Severe asthma patients symptomatic despite high dose inhaled corticosteroid and long acting beta-agonist

Device: Alair system

Interventions

Alair system DEVICE

Bronchial thermoplasty

Severe Asthma Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject Population - Severe Refractory Asthma

You may qualify if:

• Males or females age 18 or greater and less than 65
• Subject has asthma and is taking regular maintenance medication for past 12 months that includes:
• Inhaled corticosteroid (ICS) at a dosage greater than 1000μg beclomethasone per day or equivalent, AND long acting ß2-agonist (LABA) at a dosage of ≥100μg per day Salmeterol or equivalent.
• Other asthma medications such as leukotriene modifiers, or anti-IgE, are acceptable (Subjects on Xolair® must have been on Xolair for greater than 1 year).
• Asthma confirmed by: (a) b-agonist reversibility of FEV1 ≥ 12 % following 360mcg albuterol OR (b) methacholine FEV1 PC20 ≤ 8 mg/ml if not receiving an ICS or ≤ 16 mg/ml if receiving an ICS.
• FEV1 ≥ 50% predicted pre-bronchodilator.
• Asthma symptoms on at least two days or one night per week over the last 2 weeks.
• Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
• Ability to undergo bronchoscopy in the opinion of the investigator.
• Ability and willingness to provide informed consent.

You may not qualify if:

• Asthma exacerbation (ED visit, hospitalization, course of increased systemic steroids, or urgent health care visit for asthma) during the prior four weeks.
• Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year or 1 or more ICU admission for asthma in the previous year.
• Chronic oral steroid therapy greater than 30 mg per day
• Subject has other respiratory diseases including interstitial lung disease, emphysema, cystic fibrosis, vocal cord dysfunction, mechanical upper airway obstruction, untreated obstructive sleep apnea, Churg-Strauss syndrome, cardiac dysfunction, and allergic bronchopulmonary aspergillosis (total IgE of \>1000 Units/mL with positive specific IgE to aspergillus and evidence of central bronchiectasis) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation.
• Subject has segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray.
• Subject has clinically significant cardiovascular disease, including myocardial infarction, angina, cardiac dysrhythmia, conduction defect, cardiomyopathy, aortic aneurysm, or stroke.
• Subject has uncontrolled hypertension (\>200mm Hg systolic or \>100mm Hg diastolic pressure).
• Subject uses an internal or external pacemaker or cardiac defibrillator.
• Chronic diseases (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, or nervous system, or immunodeficiency
• History of cigarette smoking with \> 10 pack years total
• Use of investigative drugs or intervention trials in the 30 days prior to enrollment or during the duration of the study
• Any condition or compliance issue which in the opinion of the investigator might interfere with participation in the study

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Cleveland Clinic: collaborator
• National Jewish Health: collaborator
• University of Arizona: collaborator
• University of Chicago: collaborator
• Louisiana State University Health Sciences Center in New Orleans: collaborator
• University of Alabama at Birmingham: collaborator
• Creighton University: collaborator

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Location

University of Arizona

Tucson, Arizona, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Louisiana State University Health Sciences Center in New Orleans

New Orleans, Louisiana, 70112, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Creighton University

Omaha, Nebraska, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Samant M, Krings JG, Lew D, Goss CW, Koch T, McGregor MC, Boomer J, Hall CS, Schechtman KB, Sheshadri A, Peterson S, Erzurum S, DePew Z, Morrow LE, Hogarth DK, Tejedor R, Trevor J, Wechsler ME, Sam A, Shi X, Choi J, Castro M. Use of Quantitative CT Imaging to Identify Bronchial Thermoplasty Responders. Chest. 2024 Apr;165(4):775-784. doi: 10.1016/j.chest.2023.12.015. Epub 2023 Dec 18.

  PMID: 38123124 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA and RNA extraction, serum, plasma and sputum

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Mario Castro, MD, MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: August 19, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 27, 2020

Record last verified: 2020-11

Locations

US (8)