Clinical trial NCT01185275: A Prospective Observational Study of Biopredictors of Bronchial Thermoplasty Response in Patients With Severe Refractory Asthma (BTR Study)
Official title: A Prospective Observational Study of Biopredictors of Bronchial Thermoplasty Response in Patients With Severe Refractory Asthma (BTR Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
name: National Jewish Health
name: University of Arizona
name: University of Chicago
name: Louisiana State University Health Sciences Center in New Orleans
name: University of Alabama at Birmingham
name: Creighton University
First posted: 2010-08-19
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject Population - Severe Refractory Asthma

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Baseline predictors of response to bronchial thermoplasty defined by improvement in asthma quality of life, in patients with severe refractory asthma.
timeFrame: 12 months following last bronchial thermoplasty treatment
Secondary outcomes:
measure: Baseline predictors of severe exacerbations
timeFrame: 12 months following last bronchial thermoplasty treatment
measure: Baseline predictors of healthcare utilization
timeFrame: 12 months following last bronchial thermoplasty treatment
measure: Baseline predictors of safety of bronchial thermoplasty
timeFrame: 12 months following last bronchial thermoplasty treatment
measure: Predictive models of response to bronchial thermoplasty
timeFrame: 12 months following last bronchial thermoplasty treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center in New Orleans
state: Louisiana
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Washington University School of Medicine
name: Mario Castro, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: