Asthma
Conditions
Keywords
Refractory Asthma, Bronchial Thermoplasty, Alair System, RISA (Research in Severe Asthma)
Brief summary
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).
Detailed description
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.
Interventions
Treatment of airways with the Alair System in PREDECESSOR STUDY (NCT00214539).
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject who participated in the PREDECESSOR STUDY entitled Multicenter Randomized Clinical Trial of Bronchial Thermoplasty with the Alair™ System for the Treatment of Severe Asthma (Protocol # 0903-27). * Subject was treated with the Alair System (Alair Group) in the PREDECESSOR STUDY. * Subject who is able to read, understand, and provide written Informed Consent. * Subject who is able to comply with the study protocol, including requirements for taking and abstaining from medications, and complete all study required visits.
Exclusion criteria
* Subject participating in another clinical trial involving respiratory intervention that could affect the outcome measures of this study, either within 6 weeks of study enrollment, or during the study period. * Subject with a newly diagnosed (since exiting from the PREDECESSOR STUDY) psychiatric disorder which in the judgment of the investigator could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments | 2-year, 3-year, 4-year and 5-year follow up post procedure | The respiratory-related adverse event profile for the Alair group was analyzed on an annual basis in order to highlight trends in adverse occurrence. |
| Respiratory Adverse Events | 2-year, 3-year, 4-year and 5-year follow up post procedure | Pull down menu does not have a rate unit. Numbers reported represents Rate of Respiratory Adverse (number of Events/number of Subject/year). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalizations for Respiratory Symptoms | 2-year, 3-year, 4-year and 5-year follow up post procedure | Pull down menu does not have a rate unit. Rate of Hospitalizations for Respiratory Symptoms (number of Events/number of Subject/year) |
| Emergency Room Visits for Respiratory Symptoms | 2-year, 3-year, 4-year and 5-year follow up post procedure | Pull down menu does not have a rate unit. Rate of Emergency Room Visits for Respiratory Symptoms (number of Events/number of Subjects/year) |
Countries
Brazil, Canada, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alair Group Baseline Demographics are based on data collected at the time of entry into the PREDECESSOR STUDY (NCT00214539). | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Alair Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 38.64 years STANDARD_DEVIATION 13.31 |
| amPEF (Peak Expiratory Flow) | 369.95 L/min (liters per minute) STANDARD_DEVIATION 82.04 |
| Asthma Control Questionnaire (ACQ) Score | 2.76 scores on a scale STANDARD_DEVIATION 1.02 |
| Asthma Quality of Life Questionnaire (AQLQ) Score | 4.11 scores on a scale STANDARD_DEVIATION 1.27 |
| Emergency Room Visits | 4 Number of events |
| Hospitalizations | 10 Number of events |
| ICS Dose (Inhaled Corticosteroid dose) | 1179 µg/day (microgram/day) STANDARD_DEVIATION 421 |
| LABA Dose (Long-acting Beta Agonists) | 127 µg/day (microgram/day) STANDARD_DEVIATION 62 |
| OCS Dose (Oral corticosteroids) | 13.6 mg/day (milligrams/day) STANDARD_DEVIATION 6.3 |
| Post-Bronchodilator FEV1 | 75.19 % predicted STANDARD_DEVIATION 11.91 |
| Pre-Bronchodilator FEV1 (Forced Expiratory Volume in 1 second) | 63.46 % predicted STANDARD_DEVIATION 12.49 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment Canada | 4 participants |
| Region of Enrollment United Kingdom | 10 participants |
| Rescue Medication Use | 60.9 Puffs/7 days STANDARD_DEVIATION 60.9 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 6 Participants |
| Symptom-Free Days | 5.61 percentage of days STANDARD_DEVIATION 14.06 |
| Total Symptom Score | 5.35 scores on a scale STANDARD_DEVIATION 2.92 |
| Unscheduled Physician Office Visits | 8 Number of events |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 14 | 12 / 14 | 11 / 12 | 12 / 12 |
| serious Total, serious adverse events | 5 / 14 | 4 / 14 | 3 / 12 | 3 / 12 |
Outcome results
Primary
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
Population: A total of 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) provided consent and participated in the RISA Extension Study evaluating the longer-term safety of the Alair treatment. All 14 subjects completed their Year 3 visit and 12 subjects have completed their Year 4 and 5 visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alair Group | Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments | Year 2, n=14 | 78.6 percentage subjects with respiratory AEs |
| Alair Group | Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments | Year 3, n=14 | 85.7 percentage subjects with respiratory AEs |
| Alair Group | Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments | Year 4, n=12 | 83.3 percentage subjects with respiratory AEs |
| Alair Group | Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments | Year 5, n=12 | 100 percentage subjects with respiratory AEs |
Primary
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
Population: Subject attrition at years 4 \& 5
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alair Group | Respiratory Adverse Events | Year 2, n=14 | 1.4 Number of events/number of subject/Year |
| Alair Group | Respiratory Adverse Events | Year 3, n=14 | 2.4 Number of events/number of subject/Year |
| Alair Group | Respiratory Adverse Events | Year 4, n=12 | 1.7 Number of events/number of subject/Year |
| Alair Group | Respiratory Adverse Events | Year 5, n=12 | 2.4 Number of events/number of subject/Year |
Secondary
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
Population: Subject attrition at years 4 \& 5
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alair Group | Emergency Room Visits for Respiratory Symptoms | Year 2, n=14 | 0.3 Number of events/number of subject/Year |
| Alair Group | Emergency Room Visits for Respiratory Symptoms | Year 3, n=14 | 0 Number of events/number of subject/Year |
| Alair Group | Emergency Room Visits for Respiratory Symptoms | Year 4, n=12 | 0 Number of events/number of subject/Year |
| Alair Group | Emergency Room Visits for Respiratory Symptoms | Year 5, n=12 | 0.1 Number of events/number of subject/Year |
Secondary
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
Population: Subject attrition at years 4 \& 5
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alair Group | Hospitalizations for Respiratory Symptoms | Year 2, n=14 | 0.4 Number of events/number of subject/Year |
| Alair Group | Hospitalizations for Respiratory Symptoms | Year 3, n=14 | 0.2 Number of events/number of subject/Year |
| Alair Group | Hospitalizations for Respiratory Symptoms | Year 4, n=12 | 0.1 Number of events/number of subject/Year |
| Alair Group | Hospitalizations for Respiratory Symptoms | Year 5, n=12 | 0.1 Number of events/number of subject/Year |