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

Asthma Clinical Trial

— BTR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185275
• Other study ID #: 10-0716- 201106118
• Status: Completed
• Start date: August 2010
• Est. completion date: October 1, 2019

Study information

• Verified date: November 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Primary Aim 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.

Secondary Aims

1. To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by reduction in severe exacerbations or healthcare utilization, in patients with severe refractory asthma.

2. To evaluate if baseline clinical, physiologic, biologic and imaging markers are related to safety of bronchial thermoplasty in patients with severe refractory asthma.

3. To evaluate and validate statistical models that predict response to bronchial thermoplasty in patients with severe refractory asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Males or females age 18 or greater and less than 65

2. 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).

3. 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.

4. FEV1 = 50% predicted pre-bronchodilator.

5. Asthma symptoms on at least two days or one night per week over the last 2 weeks.

6. Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).

7. Ability to undergo bronchoscopy in the opinion of the investigator.

8. Ability and willingness to provide informed consent.

Exclusion Criteria:

1. Asthma exacerbation (ED visit, hospitalization, course of increased systemic steroids, or urgent health care visit for asthma) during the prior four weeks.

2. 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.

3. Chronic oral steroid therapy greater than 30 mg per day

4. 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.

5. Subject has segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray.

6. Subject has clinically significant cardiovascular disease, including myocardial infarction, angina, cardiac dysrhythmia, conduction defect, cardiomyopathy, aortic aneurysm, or stroke.

7. Subject has uncontrolled hypertension (>200mm Hg systolic or >100mm Hg diastolic pressure).

8. Subject uses an internal or external pacemaker or cardiac defibrillator.

9. 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

10. History of cigarette smoking with > 10 pack years total

11. Use of investigative drugs or intervention trials in the 30 days prior to enrollment or during the duration of the study

12. Any condition or compliance issue which in the opinion of the investigator might interfere with participation in the study

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Alair system
Bronchial thermoplasty

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	National Jewish Health	Denver	Colorado
United States	Louisiana State University Health Sciences Center in New Orleans	New Orleans	Louisiana
United States	Creighton University	Omaha	Nebraska
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Arizona	Tucson	Arizona

Sponsors (8)

Lead Sponsor	Collaborator
Washington University School of Medicine	Creighton University, Louisiana State University Health Sciences Center in New Orleans, National Jewish Health, The Cleveland Clinic, University of Alabama at Birmingham, University of Arizona, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline predictors of severe exacerbations	To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by reduction in severe exacerbations, in patients with severe refractory asthma.	12 months following last bronchial thermoplasty treatment
Secondary	Baseline predictors of healthcare utilization	To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by reduction in healthcare utilization, in patients with severe refractory asthma.	12 months following last bronchial thermoplasty treatment
Secondary	Baseline predictors of safety of bronchial thermoplasty	To evaluate if baseline clinical, physiologic, biologic and imaging markers are related to safety of bronchial thermoplasty in patients with severe refractory asthma.	12 months following last bronchial thermoplasty treatment
Secondary	Predictive models of response to bronchial thermoplasty	To evaluate and validate statistical models that predict response to bronchial thermoplasty in patients with severe refractory asthma.	12 months following last bronchial thermoplasty treatment