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Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma

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Trial Conditions
  • Severe Asthma
What is the purpose of this trial?

As Conditions of Approval of the PMA for the Alair System, the FDA requires Asthmatx to generate data to assess the durability of the BT treatment effect as well as safety data in the intended use population in the United States.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18  - 65 

Gender:
Both

Eligibility

Inclusion Criteria:

1. Subject is an adult between the ages of 18 to 65 years.

2. Subject is able to read, understand, and sign a written Informed Consent to
participate in the study and able to comply with the study protocol.

3. Subject has asthma and is taking regular maintenance medication that includes:

1. Inhaled corticosteroid (ICS) at a dosage greater than 1000μg beclomethasone per
day or equivalent, AND long acting β2-agonist (LABA) at a dosage of ≥100μg per
day Salmeterol or equivalent.

2. 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. Oral corticosteroids (OCS) at a dosage of up to, but not greater than 10mg per
day are acceptable.*

4. Subject has a pre-bronchodilator FEV1 of greater than or equal to 60% of predicted.

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

6. Subject is able to undergo outpatient (same day) bronchoscopy in the opinion of the
investigator or per hospital guidelines.

- NOTE: Subjects on a dosage regimen of 20mg OCS every other day may be included
as this is equivalent to an average daily dosage of 10mg.

Exclusion Criteria:

1. Subject is participating in another clinical trial within 6 weeks of the Baseline
Period involving respiratory intervention that could affect the outcome measures of
this Study.

2. Over the last 7 days of a 4 week medication stable period, subject requirement for
rescue medication use other than for prophylactic use for exercise exceeds an average
of:

1. 8 puffs per day of short-acting bronchodilator, or

2. 4 puffs per day of long-acting rescue bronchodilator, or

3. 2 nebulizer treatments per day. At the discretion of the Principal Investigator,
subjects considered as unstable on baseline medications may have medications
adjusted and re-evaluated after a 4 week medication stabilization period.

3. Subject has a post-bronchodilator FEV1 of less than 65%.

4. Subject has a history of life-threatening asthma, defined by past intubation for
asthma, or ICU admission for asthma within the prior 2 years.

5. Subject has 3 or more hospitalizations for exacerbations of asthma in the previous
year.

6. Subject has had 4 or more infections of lower respiratory tract (LRTI) requiring
antibiotics in the past 12 months.

7. Subject has had 4 or more pulses of systemic corticosteroids (tablets, suspension or
injection) for asthma symptoms in the past 12 months.

8. Subject has a known sensitivity to medications required to perform bronchoscopy (such
as lidocaine, atropine and benzodiazepines).

9. Subject has other respiratory diseases including emphysema, cystic fibrosis, vocal
cord dysfunction, mechanical upper airway obstruction, Churg-Strauss syndrome, and
allergic bronchopulmonary aspergillosis (asthma, immediate cutaneous reactivity to A.
fumigatus, total serum IgE of >1000ng/mL, elevated specific IgE and IgG to A.
fumigatus with or without evidence of central bronchiectasis).

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

11. Subject currently has clinically significant cardiovascular disease, including
myocardial infarction, angina, cardiac dysfunction, cardiac dysrhythmia, conduction
defect, cardiomyopathy, or stroke.

12. Subject has a known aortic aneurysm.

13. Subject has significant co-morbid illness such as cancer, renal failure, liver
disease, or cerebral vascular disease.

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

15. Subject has an implanted electrical stimulation device (e.g., a pacemaker, cardiac
defibrillator, or deep nerve or deep brain stimulator).

16. Subject has coagulopathy (INR > 1.5).

17. Subject has any other medical condition that would make them inappropriate for study
participation, in the Investigator's opinion.

Gender: Both
Trial Interventions
Device
  • Alair System
Other Information

Sponsor: Asthmatx, Inc.
Phase: Phase 4
Trial ID: NCT01350336
Volunteers:  Not Accepting Healthy Volunteers

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