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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.
 
ClinicalTrials.gov Identifier: NCT01350336
Recruitment Status : Completed
First Posted : May 9, 2011
Results First Posted : March 5, 2021
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE April 15, 2011
First Posted Date  ICMJE May 9, 2011
Results First Submitted Date  ICMJE January 25, 2021
Results First Posted Date  ICMJE March 5, 2021
Last Update Posted Date March 5, 2021
Actual Study Start Date  ICMJE April 7, 2011
Actual Primary Completion Date November 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2021)
Subjects Experiencing Severe Exacerbations (Rates) [ 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2011)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2021)
  • Rates of Severe Exacerbations [ Time Frame: Year 1-5 ]
    # Severe exacerbations / subject / year
  • Respiratory Adverse Event Rates [ 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.
  • Subjects With 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.
  • Emergency Room Visits for Respiratory Symptoms Rates [ Time Frame: Year 1-5 ]
    Emergency room visits for respiratory symptoms (rates of emergency room visits)
  • Subjects With Emergency Room Visits for Respiratory Symptoms [ Time Frame: Year 1-5 ]
    Subjects with Emergency room visits for respiratory symptoms
  • Hospitalizations for Respiratory Symptoms Rates [ Time Frame: Year 1-5 ]
    (# hospitalizations for respiratory symptoms / subject / year)
  • Subjects With Hospitalizations for Respiratory Symptoms [ Time Frame: Year 1-5 ]
    Subjects with hospitalizations for respiratory symptoms
  • Respiratory Serious Adverse Events Rates [ Time Frame: Year 1-5 ]
    The rate of subjects with respiratory serious adverse events (SAEs)
  • Subjects With Respiratory Serious Adverse Events [ Time Frame: Year 1-5 ]
    Subjects with Respiratory Serious Adverse Events
  • Pre-bronchodilator FEV1 [ Time Frame: Year 1-5 ]
    % Predicted Pre-bronchodilator FEV1
  • Post-bronchodilator FEV1 [ Time Frame: Year 1-5 ]
    % Predicted Post-bronchodilator FEV1
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2011)
  • Rates of Severe Exacerbations [ Time Frame: Year 1-5 ]
    (exacerbations / subject / year)
  • 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.
  • Emergency room visits for respiratory symptoms [ Time Frame: Year 1-5 ]
    Emergency room visits for respiratory symptoms (rates of emergency room visits)
  • Emergency room visits for respiratory symptoms [ Time Frame: Year 1-5 ]
    Emergency room visits for respiratory symptoms (proportion of subjects with emergency room visits for respiratory symptoms)
  • Hospitalizations for respiratory symptoms [ Time Frame: Year 1-5 ]
    (hospitalizations/ subject/ year)
  • Hospitalizations for respiratory symptoms [ Time Frame: Year 1-5 ]
    (the proportion of subjects with hospitalizations for respiratory symptoms)
  • Respiratory Serious Adverse Events [ Time Frame: Year 1-5 ]
    Pre-bronchodilator FEV1
  • Respiratory Serious Adverse Events [ Time Frame: Year 1-5 ]
    Post-bronchodilator FEV1
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bronchial Thermoplasty in Severe Persistent Asthma
Official Title  ICMJE Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Severe Asthma
Intervention  ICMJE Device: Alair System
Treatment of airways with the Alair System
Study Arms  ICMJE Experimental: Alair
Alair system
Intervention: Device: Alair System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2015)
284
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2011)
300
Actual Study Completion Date  ICMJE March 17, 2020
Actual Primary Completion Date November 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01350336
Other Study ID Numbers  ICMJE 10-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Following Last Patient Out, when Results are posted.
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Thomas S Bowman, MD Boston Scientific Corporation
PRS Account Boston Scientific Corporation
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP