Severe AsthmaPAS2NCT01350336

Bronchial Thermoplasty in Severe Persistent Asthma

A study testing Alair System in people with Severe Asthma, run by Boston Scientific Corporation at 27 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Severe Asthma
What is being tested?: Alair System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 284 participants
Where: 27 sitesin 2 countries
Study dates: 7 Apr 2011to 17 Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is an adult between the ages of 18 to 65 years.
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.
Subject has asthma and is taking regular maintenance medication that includes:
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.
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).
Oral corticosteroids (OCS) at a dosage of up to, but not greater than 10mg per day are acceptable.*

Show all 12Show fewer

Subject has a pre-bronchodilator FEV1 of greater than or equal to 60% of predicted.
Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
Subject is able to undergo outpatient (same day) bronchoscopy in the opinion of the investigator or per hospital guidelines.
Subject has at least 2 days of asthma symptoms in the last 4 weeks.
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.

Who cannot join

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.
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:
8 puffs per day of short-acting bronchodilator, or
4 puffs per day of long-acting rescue bronchodilator, or
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.
Subject has a post-bronchodilator FEV1 of less than 65%.

Show all 20Show fewer

Subject has a history of life-threatening asthma, defined by past intubation for asthma, or ICU admission for asthma within the prior 2 years.
Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year.
Subject has had 4 or more infections of lower respiratory tract (LRTI) requiring antibiotics in the past 12 months.
Subject has had 4 or more pulses of systemic corticosteroids (tablets, suspension or injection) for asthma symptoms in the past 12 months.
Subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
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).
Subject has segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray.
Subject currently has clinically significant cardiovascular disease, including myocardial infarction, angina, cardiac dysfunction, cardiac dysrhythmia, conduction defect, cardiomyopathy, or stroke.
Subject has a known aortic aneurysm.
Subject has significant co-morbid illness such as cancer, renal failure, liver disease, or cerebral vascular disease.
Subject has uncontrolled hypertension (>200mm Hg systolic or >100mm Hg diastolic pressure).
Subject has an implanted electrical stimulation device (e.g., a pacemaker, cardiac defibrillator, or deep nerve or deep brain stimulator).
Subject has coagulopathy (INR > 1.5).
Subject has any other medical condition that would make them inappropriate for study participation, in the Investigator's opinion.

Trial locations and contacts

27 sites in 2 countries.

Country

City, postcode or hospital

27 sites in 2 countries

United States23 sites

University of Alabama at Birmingham Lung Health Center
Birmingham, Alabama, 35294
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lahey Clinic
Burlington, Massachusetts, 01805
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia Medical Center
Charlottesville, Virginia, 22908
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Henry Ford Hospital
Detroit, Michigan, 48202
DuBois Regional Medical Center
DuBois, Pennsylvania, 15801
Duke University
Durham, North Carolina, 27710
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503
Pennsylvania State Hershey
Hershey, Pennsylvania, 17033
University of Iowa
Iowa City, Iowa, 52242
University of Wisconsin
Madison, Wisconsin, 53792
Yale University Center for Asthma and Airway Disease
New Haven, Connecticut, 06520
LSU Health Sciences
New Orleans, Louisiana, 70112
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pulmonary Associates of Richmond
Richmond, Virginia, 23225
HealthPartners Specialty Center, Lung and Sleep Health
Saint Paul, Minnesota, 55103
Washington University School of Medicine
St Louis, Missouri, 63110
Franciscan Research Center (St. Joseph Medical Center)
Tacoma, Washington, 98405
MultiCare Pulmonary Specialists
Tacoma, Washington, 98405

Other trials in United States

Canada4 sites

Montreal Chest Institute
Montreal, Quebec, H2X 2P4
Hospital Laval Centre de Pneumologie
Sainte-Foy, Quebec, G1V 4G5
Surrey Memorial Hospital
Surrey, British Columbia, V3T 0G9
Vancouver General Hospital, University of British Columbia
Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

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

Read the 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).

Conditions: Severe Asthma
Being tested: Alair System
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Alair SystemDevice
Treatment of airways with the Alair System

Study groups in NCT01350336
Study group	Role	What they receive
Alair	Experimental	Alair system Receives: Device: Alair System

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjects Experiencing Severe Exacerbations (Rates)
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.
Measured: Year 1 vs. Year 2, 3, 4, 5

Secondary outcomes (11)

Rates of Severe Exacerbations
# Severe exacerbations / subject / year
Measured: Year 1-5
Respiratory Adverse Event Rates
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.
Measured: Year 1-5
Subjects With Respiratory Adverse Events
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.
Measured: Year 1-5
Emergency Room Visits for Respiratory Symptoms Rates
Emergency room visits for respiratory symptoms (rates of emergency room visits)
Measured: Year 1-5
Subjects With Emergency Room Visits for Respiratory Symptoms
Subjects with Emergency room visits for respiratory symptoms
Measured: Year 1-5
Hospitalizations for Respiratory Symptoms Rates
(# hospitalizations for respiratory symptoms / subject / year)
Measured: Year 1-5
Subjects With Hospitalizations for Respiratory Symptoms
Subjects with hospitalizations for respiratory symptoms
Measured: Year 1-5
Respiratory Serious Adverse Events Rates
The rate of subjects with respiratory serious adverse events (SAEs)
Measured: Year 1-5
Subjects With Respiratory Serious Adverse Events
Subjects with Respiratory Serious Adverse Events
Measured: Year 1-5
Pre-bronchodilator FEV1
% Predicted Pre-bronchodilator FEV1
Measured: Year 1-5
Post-bronchodilator FEV1
% Predicted Post-bronchodilator FEV1
Measured: Year 1-5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Apr 201117 Mar 2020

First posted9 May 2011 (estimated)
Study start7 Apr 2011
Primary completion12 Nov 2019
Study completion17 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Severe AsthmaStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 284 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01350336
Sponsor's protocol ID: 10-02
Acronym: PAS2
Status last verified: Feb 2021
First submitted: 15 Apr 2011
Last updated: 5 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes

Publications

Chupp G, Kline JN, Khatri SB, McEvoy C, Silvestri GA, Shifren A, Castro M, Bansal S, McClelland M, Dransfield M, Trevor J, Kahlstrom N, Simoff M, Wahidi MM, Lamb CR, Ferguson JS, Haas A, Hogarth DK, Tejedor R, Toth J, Hey J, Majid A, LaCamera P, Fitzgerald JM, Enfield K, Grubb GM, McMullen EA, Olson JL, Laviolette M. Bronchial Thermoplasty in Patients With Severe Asthma at 5 Years: The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma Study. Chest. 2022 Mar;161(3):614-628. doi: 10.1016/j.chest.2021.10.044. Epub 2021 Nov 10.
PubMed 34774528

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Severe Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma
ClinicalTrials.gov ID: NCT01350336
Acronym / sponsor ID: PAS2 / 10-02
Conditions: Severe Asthma
Study type: Interventional
Recruitment status: Completed
Enrolment: 284 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 7 Apr 2011 (actual)
Primary completion: 12 Nov 2019 (actual)
Study completion: 17 Mar 2020 (actual)
First posted: 9 May 2011 (estimated)
Results: Posted 5 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Alair	Experimental	Device: Alair SystemAlair system

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Subject is an adult between the ages of 18 to 65 years.
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.
Subject has asthma and is taking regular maintenance medication that includes:
Subject has a pre-bronchodilator FEV1 of greater than or equal to 60% of predicted.
Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).

Key exclusion criteria (20 listed)

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.
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:
Subject has a post-bronchodilator FEV1 of less than 65%.
Subject has a history of life-threatening asthma, defined by past intubation for asthma, or ICU admission for asthma within the prior 2 years.
Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Alair SystemTreatment of airways with the Alair System	Device	Alair

Primary outcome

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.

11 secondary outcomes

Rates of Severe Exacerbations
Time frame: Year 1-5
Respiratory Adverse Event Rates
Time frame: Year 1-5
Subjects With Respiratory Adverse Events
Time frame: Year 1-5
Emergency Room Visits for Respiratory Symptoms Rates
Time frame: Year 1-5
Subjects With Emergency Room Visits for Respiratory Symptoms
Time frame: Year 1-5
Hospitalizations for Respiratory Symptoms Rates
Time frame: Year 1-5
Subjects With Hospitalizations for Respiratory Symptoms
Time frame: Year 1-5
Respiratory Serious Adverse Events Rates
Time frame: Year 1-5
Subjects With Respiratory Serious Adverse Events
Time frame: Year 1-5
Pre-bronchodilator FEV1
Time frame: Year 1-5
Post-bronchodilator FEV1
Time frame: Year 1-5

Results and safety

Results posted to the registry on 5 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alair	284	227

Primary outcome: Subjects Experiencing Severe Exacerbations (Rates)

Time frame: Year 1 vs. Year 2, 3, 4, 5. Count of participants. Unit: Participants

Measure	Year 1 n = 262	Year 2 n = 252	Year 3 n = 247	Year 4 n = 240	Year 5 n = 227
Value	132	118	118	106	97

Year 1 vs Year 2: Difference of proportions: -0.0380 (95% CI -0.1251 to 0.0497)
Year 1 vs Year 3: Difference of proportions: -0.0325 (95% CI -0.1197 to 0.0565)
Year 1 vs Year 4: Difference of proportions: -0.0566 (95% CI -0.1444 to 0.0329)

Population analysed: Primary Endpoint - 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.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 Years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alair	130 of 279 (46.6%)	268 of 279 (96.1%)	4 of 279

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34774528Chupp G, Kline JN, Khatri SB, McEvoy C, Silvestri GA, Shifren A, Castro M, Bansal S, McClelland M, Dransfield M, Trevor J, Kahlstrom N, Simoff M, Wahidi MM, Lamb CR, Ferguson JS, Haas A, Hogarth DK, Tejedor R, Toth J, Hey J, Majid A, LaCamera P, Fitzgerald JM, Enfield K, Grubb GM, McMullen EA, Olson JL, Laviolette M. Bronchial Thermoplasty in Patients With Severe Asthma at 5 Years: The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma Study. Chest. 2022 Mar;161(3):614-628. doi: 10.1016/j.chest.2021.10.044. Epub 2021 Nov 10.
Bronchial ThermoplastyLink provided by the sponsor.
Individual participant dataSharing planned: Yes

Related trials for Severe Asthma

RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
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Recruiting
Characterization of Natural Killer Cells in Severe Asthma Patients in Comparison With Control Subjects
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Active, not recruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas S Bowman, MD study director

Boston Scientific Corporation

27 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Alair System in people with Severe Asthma, run by Boston Scientific Corporation at 27 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjects Experiencing Severe Exacerbations (Rates) (time frame: Year 1 vs. Year 2, 3, 4, 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01350336, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.