An observational study in Asthma, sponsored by Boston Scientific Corporation. Completed at 8 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by Boston Scientific Corporation · Observational
The primary purpose of this study is to gather additional safety data for the subjects treated with the Alair System (hereinafter, "Alair-Treated Subjects") who previously completed the one-year study entitled: "Multicenter Randomized Clinical Trial of Bronchial Thermoplasty with the Alair System for the Treatment of Severe Asthma" (Protocol #0903-27) sponsored by Asthmatx, Inc. Subjects who elect to participate in this safety study will be followed for an additional four (4) year period beyond the PREDECESSOR STUDY'S one-year endpoint (clinicaltrials.gov number NCT00214539).
This will be a multicenter study conducted only at the clinical sites that participated in the PREDECESSOR STUDY (NCT00214539).
Enrollment will be limited to only those subjects who were treated with the Alair System in the PREDECESSOR STUDY.
Written, informed consent will be obtained from all subjects prior to performing any study procedures.
The present study will extend the follow-up evaluation of Alair-Treated Subjects from the PREDECESSOR STUDY to 5 years post-treatment with the Alair System. These evaluations will consist of four study visits corresponding to the two-year, three-year, four-year and five-year time points following completion of Alair treatments in the PREDECESSOR STUDY. For consistency with the PREDECESSOR STUDY, ideally the subject's drug therapy should continue to be consistent with GINA (Global Initiative for Asthma) Guidelines for the severity of the subject's asthma. Any changes in maintenance levels of asthma medications will be documented.
The goal of this follow-on study is to enroll all Alair-Treated Subjects who completed the PREDECESSOR STUDY. Inclusion of subjects from the treatment arm will allow for better assessment of the long-term safety of the Alair procedure.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 14 is below the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with severe asthma, previously treated with the Alair System in the PREDECESSOR STUDY (NCT00214539).
Exclusion Criteria:
Alair Treated subjects from PREDECESSOR STUDY (NCT00214539).
Device: Bronchial thermoplasty with the Alair System
Treatment of airways with the Alair System in PREDECESSOR STUDY (NCT00214539).
Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments
The respiratory-related adverse event profile for the Alair group was analyzed on an annual basis in order to highlight trends in adverse occurrence.
Time frame: 2-year, 3-year, 4-year and 5-year follow up post procedure
Respiratory Adverse Events
Pull down menu does not have a rate unit. Numbers reported represents Rate of Respiratory Adverse (number of Events/number of Subject/year).
Time frame: 2-year, 3-year, 4-year and 5-year follow up post procedure
Hospitalizations for Respiratory Symptoms
Pull down menu does not have a rate unit. Rate of Hospitalizations for Respiratory Symptoms (number of Events/number of Subject/year)
Time frame: 2-year, 3-year, 4-year and 5-year follow up post procedure
Emergency Room Visits for Respiratory Symptoms
Pull down menu does not have a rate unit. Rate of Emergency Room Visits for Respiratory Symptoms (number of Events/number of Subjects/year)
Time frame: 2-year, 3-year, 4-year and 5-year follow up post procedure
| Milestone | Alair Group |
|---|---|
| Started | 14 |
| Completed | 12 |
| Not completed | 2 |
The respiratory-related adverse event profile for the Alair group was analyzed on an annual basis in order to highlight trends in adverse occurrence.
| percentage subjects with respiratory AEs | Alair Group |
|---|---|
| Year 2, n=14 | 78.6 |
| Year 3, n=14 | 85.7 |
| Year 4, n=12 | 83.3 |
| Year 5, n=12 | 100 |
Pull down menu does not have a rate unit. Numbers reported represents Rate of Respiratory Adverse (number of Events/number of Subject/year).
| Number of events/number of subject/Year | Alair Group |
|---|---|
| Year 2, n=14 | 1.4 |
| Year 3, n=14 | 2.4 |
| Year 4, n=12 | 1.7 |
| Year 5, n=12 | 2.4 |
Pull down menu does not have a rate unit. Rate of Hospitalizations for Respiratory Symptoms (number of Events/number of Subject/year)
| Number of events/number of subject/Year | Alair Group |
|---|---|
| Year 2, n=14 | 0.4 |
| Year 3, n=14 | 0.2 |
| Year 4, n=12 | 0.1 |
| Year 5, n=12 | 0.1 |
Pull down menu does not have a rate unit. Rate of Emergency Room Visits for Respiratory Symptoms (number of Events/number of Subjects/year)
| Number of events/number of subject/Year | Alair Group |
|---|---|
| Year 2, n=14 | 0.3 |
| Year 3, n=14 | 0 |
| Year 4, n=12 | 0 |
| Year 5, n=12 | 0.1 |
Collected over Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Year 2 | — | 5/14 (35.7%) | 11/14 (78.6%) |
| Year 3 | — | 4/14 (28.6%) | 12/14 (85.7%) |
| Year 4 | — | 3/12 (25%) | 11/12 (91.7%) |
| Year 5 | — | 3/12 (25%) | 12/12 (100%) |
| Event | Year 2 | Year 3 | Year 4 | Year 5 |
|---|---|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 3/14 | 1/14 | 0/12 | 1/12 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/14 | 0/14 | 2/12 | 0/12 |
| Tibia fractureInjury, poisoning and procedural complications | 0/14 | 0/14 | 0/12 | 1/12 |
| Chest painRespiratory, thoracic and mediastinal disorders | 0/14 | 0/14 | 0/12 | 1/12 |
| Asthma exacerbation prophylaxisSurgical and medical procedures | 0/14 | 1/14 | 1/12 | 0/12 |
| Sinus tachycardiaCardiac disorders | 0/14 | 1/14 | 0/12 | 0/12 |
| VomitingGastrointestinal disorders | 0/14 | 1/14 | 0/12 | 0/12 |
| Sudden DeathInjury, poisoning and procedural complications | 0/14 | 1/14 | 0/12 | 0/12 |
| Renal colicRenal and urinary disorders | 1/14 | 0/14 | 0/12 | 0/12 |
| Lower respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 1/14 | 0/14 | 0/12 | 0/12 |
| Event | Year 2 | Year 3 | Year 4 | Year 5 |
|---|---|---|---|---|
| Lower respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 5/14 | 4/14 | 5/12 | 7/12 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 5/14 | 7/14 | 2/12 | 4/12 |
| BronchitisRespiratory, thoracic and mediastinal disorders | 2/14 | 3/14 | 1/12 | 1/12 |
| Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 0/14 | 2/14 | 2/12 | 2/12 |
| ArthritisMusculoskeletal and connective tissue disorders | 0/14 | 0/14 | 2/12 | 0/12 |
| Chest painRespiratory, thoracic and mediastinal disorders | 0/14 | 2/14 | 1/12 | 1/12 |
| WheezingRespiratory, thoracic and mediastinal disorders | 1/14 | 2/14 | 0/12 | 1/12 |
| Chest discomfortRespiratory, thoracic and mediastinal disorders | 0/14 | 0/14 | 0/12 | 1/12 |
| Chronic obstructive airways disease exacerbatedRespiratory, thoracic and mediastinal disorders | 0/14 | 0/14 | 0/12 | 1/12 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/14 | 0/14 | 1/12 | 0/12 |
| Age, Categorical(Participants) | Alair Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 14 |
| >=65 years | 0 |
| Age, Continuous(years) | Alair Group |
|---|---|
| Mean | 38.64 ± 13.31 |
| Sex: Female, Male(Participants) | Alair Group |
|---|---|
| Female | 8 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | Alair Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Alair Group |
|---|---|
| Canada | 4 |
| United Kingdom | 10 |
| amPEF (Peak Expiratory Flow)(L/min (liters per minute)) | Alair Group |
|---|---|
| Mean | 369.95 ± 82.04 |
| Pre-Bronchodilator FEV1 (Forced Expiratory Volume in 1 second)(% predicted) | Alair Group |
|---|---|
| Mean | 63.46 ± 12.49 |
| Post-Bronchodilator FEV1(% predicted) | Alair Group |
|---|---|
| Mean | 75.19 ± 11.91 |
11 further baseline measures are reported on the registry.
Plan to share: Undecided
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Boston Scientific Corporation