Bronchial Thermoplasty in Severe Persistent Asthma (PAS2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01350336
Recruitment Status : Active, not recruiting
First Posted : May 9, 2011
Last Update Posted : June 29, 2018
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
As Conditions of Approval of the PMA for the Alair System, the FDA requires Boston Scientific 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.

Condition or disease Intervention/treatment Phase
Severe Asthma Device: Alair System Not Applicable

Detailed Description:
This is a multicenter, open-label, single arm study designed to demonstrate durability of the treatment effect and to evaluate the short-term and longer-term safety profile of the Alair System in the United States in the intended use population (patients 18 years and older with severe persistent asthma).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma
Study Start Date : April 2011
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Alair
Alair system
Device: Alair System
Treatment of airways with the Alair System

Primary Outcome Measures :
  1. Subjects experiencing severe exacerbations [ Time Frame: Year 1 vs. Year 2, 3, 4, 5 ]
    The primary endpoint will be the proportion of subjects experiencing severe exacerbations during the subsequent 12-month (for Years 2, 3, 4, and 5) compared to the first 12-month after the Alair treatment.

Secondary Outcome Measures :
  1. Rates of Severe exacerbations [ Time Frame: Year 1-5 ]
    (exacerbations / subject / year)

  2. Respiratory adverse events [ Time Frame: Year 1-5 ]
    A respiratory adverse event is defined as any sign, symptom, illness, clinically significant abnormal laboratory value, or other adverse medical event associated with the "Respiratory System" that appears or worsens in a subject during a clinical study, regardless of whether or not it is considered related to the procedure used as part of the protocol.

  3. Emergency room visits for respiratory symptoms rates [ Time Frame: Year 1-5 ]
    Emergency room visits for respiratory symptoms (rates of emergency room visits)

  4. Emergency room visits for respiratory symptoms proportions [ Time Frame: Year 1-5 ]
    Emergency room visits for respiratory symptoms (proportion of subjects with emergency room visits for respiratory symptoms)

  5. Hospitalizations for respiratory symptoms rates [ Time Frame: Year 1-5 ]
    (hospitalizations/ subject/ year)

  6. Hospitalizations for respiratory symptoms proportions [ Time Frame: Year 1-5 ]
    (the proportion of subjects with hospitalizations for respiratory symptoms)

  7. Respiratory Serious Adverse Events rates [ Time Frame: Year 1-5 ]
    The rate of subjects with serious adverse events

  8. Respiratory Serious Adverse Events proportions [ Time Frame: Year 1-5 ]
    The proportion of subjects with Serious Adverse Events

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 ≥80μg 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.
  7. Subject has at least 2 days of asthma symptoms in the last 4 weeks.
  8. Subject has an AQLQ score during the baseline period of 6.25 or less.

    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01350336

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Sponsors and Collaborators
Boston Scientific Corporation
Study Director: Thomas S Bowman, MD Boston Scientific Corporation

Additional Information:
Responsible Party: Boston Scientific Corporation Identifier: NCT01350336     History of Changes
Other Study ID Numbers: 10-02
First Posted: May 9, 2011    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases