Asthma
Conditions
Keywords
Alair System, Bronchial Thermoplasty, Long-term Safety
Brief summary
The primary purpose of this study is to gather additional safety data for subjects who previously completed the one-year study entitled: Multicenter Randomized Clinical Trial of the Alair System for the Bronchial Thermoplasty Treatment of Asthma (Protocol #0602-20, NCT00214526) sponsored by Asthmatx, Inc. Study Subjects who were assigned to the Control Group who elect to participate in this extension study will be followed for an additional two (2) - year period beyond the PREDECESSOR STUDY'S one-year endpoint. Subjects treated with the Alair System who elect to participate in this extension study will be followed for an additional four (4)- year period beyond the PREDECESSOR STUDY'S one-year endpoint. All treatments with the Alair System were completed in the PREDECESSOR STUDY (NCT00214526). The current study is designed solely to collect longer-term follow-up data on the effects of the treatments. The data will be of the same type that was collected in the PREDECESSOR STUDY (NCT00214526), including spirometry, physical examinations, review of symptoms, use of maintenance and rescue medications, and response to Methacholine challenge.
Detailed description
This will be a multicenter study conducted only at the clinical sites that participated in the PREDECESSOR STUDY (NCT00214526). Written, informed consent will be obtained prior to performing any study procedures. Enrollment will be limited to only those subjects who were in either the Control or Treatment groups of the PREDECESSOR STUDY (NCT00214526). The present study will extend the follow-up evaluation of subjects from the PREDECESSOR STUDY (NCT00214526) to 3 years post-treatment for the Control Subjects and 5 years post-treatment for Alair-Treated Subjects. These evaluations will consist of two (Control Group) to four (Alair Group) additional study visits corresponding to the two-year, three-year, four-year and five-year time points following completion of Alair treatments (or similar time point for control subjects) in the PREDECESSOR STUDY (NCT00214526). For consistency with the PREDECESSOR STUDY (NCT00214526), ideally the subject's drug therapy should continue to be consistent with the Global Initiative for Asthma (GINA) Guidelines for the severity of the subject's asthma. Any changes in maintenance levels of asthma medications should be documented. The goal of this follow-up study is to enroll all subjects who participated in the PREDECESSOR STUDY (NCT00214526). Inclusion of subjects from the treatment arm will allow for the assessment of long-term safety of the Alair procedure for up to 5 years post treatment with the Alair System. Inclusion of subjects from the Control arm will allow for appropriate analysis of long-term effectiveness data for up to 3 years post treatment.
Interventions
Treatment of airways with the Alair System (Bronchial Thermoplasty) in the PREDECESSOR STUDY (NCT00214526).
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Subject who participated in the PREDECESSOR STUDY entitled Multicenter Randomized Clinical Trial of the Alair System for the Bronchial Thermoplasty Treatment of Asthma(Protocol # 0602-20, NCT00214526). 2. Subject who is able to read, understand, and provide written Informed Consent. 3. 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
1. 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. 2. 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 Any Respiratory Adverse Event | 12 Month periods out to 5 years | There is not one specific primary outcome measure. The primary objective of this study is to gather additional, longer-term safety data in subjects who participated in the AIR Trial (Protocol #0602-20), called the AIR PREDECESSOR STUDY in the AIR Extension Report (NCT00214526). The 'Percentage of Subjects with any Respiratory Adverse Event' was chosen to be the primary outcome measure because it is the first described in the final study report. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health Care Usage | 12 Month periods out to 5 years | — |
| Number of Respiratory Adverse Events | 12 Month periods out to 5 years | Number of respiratory adverse events per subject |
| Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | 12 Month periods out to 5 years | — |
Countries
Brazil, Canada, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alair Treatment Alair treated subjects from PREDECESSOR STUDY (NCT00214526).
Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY. | 45 |
| Control Control group subjects from PREDECESSOR STUDY (NCT00214526). | 24 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Year 2 | Missed visit but remained in study | 4 | 1 |
| Year 3 | Lost to Follow-up | 1 | 0 |
| Year 3 | Missed visit but remained in study | 2 | 0 |
| Year 3 | Withdrawal by Subject | 1 | 3 |
| Year 5 | Missed visit but remained in study | 1 | 0 |
Baseline characteristics
| Characteristic | Alair Treatment | Control | Total |
|---|---|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 11.21 | 40.88 years STANDARD_DEVIATION 12.13 | 40.30 years STANDARD_DEVIATION 11.46 |
| Asthma Control Questionnaire (ACQ) Overall Score LABA Stable | 1.39 Scores on a scale STANDARD_DEVIATION 0.68 | 1.29 Scores on a scale STANDARD_DEVIATION 0.7 | 1.36 Scores on a scale STANDARD_DEVIATION 0.89 |
| Asthma Control Questionnaire (ACQ) Overall Score LABA Withdrawal | 2.50 Scores on a scale STANDARD_DEVIATION 0.97 | 2.08 Scores on a scale STANDARD_DEVIATION 0.9 | 2.35 Scores on a scale STANDARD_DEVIATION 0.96 |
| Asthma Quality of Life Questionnaire (AQLQ) Score LABA Stable | 5.65 Scores on a scale STANDARD_DEVIATION 0.99 | 5.62 Scores on a scale STANDARD_DEVIATION 0.92 | 5.64 Scores on a scale STANDARD_DEVIATION 0.96 |
| Asthma Quality of Life Questionnaire (AQLQ) Score LABA Withdrawal | 4.88 Scores on a scale STANDARD_DEVIATION 1.3 | 4.84 Scores on a scale STANDARD_DEVIATION 1.4 | 4.86 Scores on a scale STANDARD_DEVIATION 1.33 |
| Height (cm) | 166.17 cm STANDARD_DEVIATION 9.64 | 164.83 cm STANDARD_DEVIATION 7.72 | 165.70 cm STANDARD_DEVIATION 8.99 |
| Inhaled Corticosteroid Dose | 1291.11 mcg (micrograms) STANDARD_DEVIATION 862.1 | 1135.42 mcg (micrograms) STANDARD_DEVIATION 1030.46 | 1236.96 mcg (micrograms) STANDARD_DEVIATION 919.58 |
| Long-acting Beta Agonists (LABA) Dose | 108.89 mcg (micrograms) STANDARD_DEVIATION 33.78 | 100.00 mcg (micrograms) STANDARD_DEVIATION 14.74 | 105.80 mcg (micrograms) STANDARD_DEVIATION 28.81 |
| Methacholine PC20 | 0.25 mg/ml | 0.28 mg/ml | 0.26 mg/ml |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Black | 3 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized Hispanic | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 41 participants | 22 participants | 63 participants |
| Sex: Female, Male Female | 26 Participants | 15 Participants | 41 Participants |
| Sex: Female, Male Male | 19 Participants | 9 Participants | 28 Participants |
| Weight (kg) | 76.37 kg STANDARD_DEVIATION 23.31 | 77.71 kg STANDARD_DEVIATION 16.95 | 76.84 kg STANDARD_DEVIATION 21.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 | 0 / 43 | 0 / 43 | 0 / 42 | 0 / 24 | 0 / 23 | 0 / 21 |
| other Total, other adverse events | 42 / 45 | 23 / 45 | 23 / 43 | 22 / 43 | 22 / 42 | 19 / 24 | 12 / 23 | 11 / 21 |
| serious Total, serious adverse events | 4 / 45 | 4 / 45 | 3 / 43 | 3 / 43 | 3 / 42 | 2 / 24 | 0 / 23 | 1 / 21 |
Outcome results
Primary
Percentage of Subjects With Any Respiratory Adverse Event
There is not one specific primary outcome measure. The primary objective of this study is to gather additional, longer-term safety data in subjects who participated in the AIR Trial (Protocol #0602-20), called the AIR PREDECESSOR STUDY in the AIR Extension Report (NCT00214526). The 'Percentage of Subjects with any Respiratory Adverse Event' was chosen to be the primary outcome measure because it is the first described in the final study report.
Time frame: 12 Month periods out to 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alair Year 1 | Percentage of Subjects With Any Respiratory Adverse Event | 38 Participants |
| Alair Year 2 | Percentage of Subjects With Any Respiratory Adverse Event | 24 Participants |
| Alair Year 3 | Percentage of Subjects With Any Respiratory Adverse Event | 24 Participants |
| Alair Year 4 | Percentage of Subjects With Any Respiratory Adverse Event | 23 Participants |
| Alair Year 5 | Percentage of Subjects With Any Respiratory Adverse Event | 22 Participants |
| Control Year 1 | Percentage of Subjects With Any Respiratory Adverse Event | 18 Participants |
| Control Year 2 | Percentage of Subjects With Any Respiratory Adverse Event | 13 Participants |
| Control Year 3 | Percentage of Subjects With Any Respiratory Adverse Event | 12 Participants |
Other Pre-specified
Forced Expiratory Volume in 1 Second (FEV1) - % Predicted
Time frame: 12 Month periods out to 5 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alair Year 1 | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Pre-Bronchodilator Off-LABA | 76.0 percentage predicted | Standard Deviation 14 |
| Alair Year 1 | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Post-Bronchodilator Off-LABA | 84.5 percentage predicted | Standard Deviation 13.3 |
| Alair Year 2 | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Pre-Bronchodilator Off-LABA | 73.5 percentage predicted | Standard Deviation 15 |
| Alair Year 2 | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Post-Bronchodilator Off-LABA | 85.0 percentage predicted | Standard Deviation 13.1 |
| Alair Year 3 | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Pre-Bronchodilator Off-LABA | 73.9 percentage predicted | Standard Deviation 12.6 |
| Alair Year 3 | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Post-Bronchodilator Off-LABA | 85.1 percentage predicted | Standard Deviation 11.6 |
| Alair Year 4 | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Pre-Bronchodilator Off-LABA | 74.3 percentage predicted | Standard Deviation 15 |
| Alair Year 4 | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Post-Bronchodilator Off-LABA | 84.6 percentage predicted | Standard Deviation 14.2 |
| Alair Year 5 | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Pre-Bronchodilator Off-LABA | 70.6 percentage predicted | Standard Deviation 14.6 |
| Alair Year 5 | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Post-Bronchodilator Off-LABA | 83.5 percentage predicted | Standard Deviation 13.5 |
| Control Year 1 | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Pre-Bronchodilator Off-LABA | 71.6 percentage predicted | Standard Deviation 11.6 |
| Control Year 1 | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Post-Bronchodilator Off-LABA | 82.2 percentage predicted | Standard Deviation 8.5 |
| Control Year 2 | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Post-Bronchodilator Off-LABA | 86.3 percentage predicted | Standard Deviation 9.7 |
| Control Year 2 | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Pre-Bronchodilator Off-LABA | 74.8 percentage predicted | Standard Deviation 10.6 |
| Control Year 3 | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Pre-Bronchodilator Off-LABA | 70.1 percentage predicted | Standard Deviation 16.9 |
| Control Year 3 | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Post-Bronchodilator Off-LABA | 80.7 percentage predicted | Standard Deviation 19.8 |
Other Pre-specified
Health Care Usage
Time frame: 12 Month periods out to 5 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alair Year 1 | Health Care Usage | Hospitalizations for Respiratory Symptoms | 0.07 Number events per subject | Standard Deviation 0.25 |
| Alair Year 1 | Health Care Usage | Unscheduled Physician Office Visits for Respiratory Symptoms | 0.42 Number events per subject | Standard Deviation 0.72 |
| Alair Year 1 | Health Care Usage | Emergency Room (ER) Visits for Respiratory Symptoms | 0.04 Number events per subject | Standard Deviation 0.21 |
| Alair Year 2 | Health Care Usage | Unscheduled Physician Office Visits for Respiratory Symptoms | 0.18 Number events per subject | Standard Deviation 0.44 |
| Alair Year 2 | Health Care Usage | Emergency Room (ER) Visits for Respiratory Symptoms | 0.07 Number events per subject | Standard Deviation 0.25 |
| Alair Year 2 | Health Care Usage | Hospitalizations for Respiratory Symptoms | 0.07 Number events per subject | Standard Deviation 0.25 |
| Alair Year 3 | Health Care Usage | Unscheduled Physician Office Visits for Respiratory Symptoms | 0.44 Number events per subject | Standard Deviation 0.7 |
| Alair Year 3 | Health Care Usage | Hospitalizations for Respiratory Symptoms | 0.07 Number events per subject | Standard Deviation 0.46 |
| Alair Year 3 | Health Care Usage | Emergency Room (ER) Visits for Respiratory Symptoms | 0.07 Number events per subject | Standard Deviation 0.34 |
| Alair Year 4 | Health Care Usage | Hospitalizations for Respiratory Symptoms | 0.02 Number events per subject | Standard Deviation 0.15 |
| Alair Year 4 | Health Care Usage | Emergency Room (ER) Visits for Respiratory Symptoms | 0.14 Number events per subject | Standard Deviation 0.47 |
| Alair Year 4 | Health Care Usage | Unscheduled Physician Office Visits for Respiratory Symptoms | 0.70 Number events per subject | Standard Deviation 1.21 |
| Alair Year 5 | Health Care Usage | Emergency Room (ER) Visits for Respiratory Symptoms | 0.05 Number events per subject | Standard Deviation 0.22 |
| Alair Year 5 | Health Care Usage | Hospitalizations for Respiratory Symptoms | 0.02 Number events per subject | Standard Deviation 0.15 |
| Alair Year 5 | Health Care Usage | Unscheduled Physician Office Visits for Respiratory Symptoms | 0.48 Number events per subject | Standard Deviation 0.94 |
| Control Year 1 | Health Care Usage | Emergency Room (ER) Visits for Respiratory Symptoms | 0.00 Number events per subject | Standard Deviation 0 |
| Control Year 1 | Health Care Usage | Hospitalizations for Respiratory Symptoms | 0.00 Number events per subject | Standard Deviation 0 |
| Control Year 1 | Health Care Usage | Unscheduled Physician Office Visits for Respiratory Symptoms | 0.42 Number events per subject | Standard Deviation 0.72 |
| Control Year 2 | Health Care Usage | Emergency Room (ER) Visits for Respiratory Symptoms | 0.13 Number events per subject | Standard Deviation 0.34 |
| Control Year 2 | Health Care Usage | Hospitalizations for Respiratory Symptoms | 0.00 Number events per subject | Standard Deviation 0 |
| Control Year 2 | Health Care Usage | Unscheduled Physician Office Visits for Respiratory Symptoms | 0.25 Number events per subject | Standard Deviation 0.74 |
| Control Year 3 | Health Care Usage | Hospitalizations for Respiratory Symptoms | 0.05 Number events per subject | Standard Deviation 0.22 |
| Control Year 3 | Health Care Usage | Emergency Room (ER) Visits for Respiratory Symptoms | 0.14 Number events per subject | Standard Deviation 0.85 |
| Control Year 3 | Health Care Usage | Unscheduled Physician Office Visits for Respiratory Symptoms | 0.29 Number events per subject | Standard Deviation 0.64 |
Other Pre-specified
Number of Respiratory Adverse Events
Number of respiratory adverse events per subject
Time frame: 12 Month periods out to 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alair Year 1 | Number of Respiratory Adverse Events | 4.5 Number events per subject | Standard Deviation 4.2 |
| Alair Year 2 | Number of Respiratory Adverse Events | 1.2 Number events per subject | Standard Deviation 1.6 |
| Alair Year 3 | Number of Respiratory Adverse Events | 1.3 Number events per subject | Standard Deviation 1.9 |
| Alair Year 4 | Number of Respiratory Adverse Events | 1.2 Number events per subject | Standard Deviation 1.6 |
| Alair Year 5 | Number of Respiratory Adverse Events | 1.1 Number events per subject | Standard Deviation 2.2 |
| Control Year 1 | Number of Respiratory Adverse Events | 3.1 Number events per subject | Standard Deviation 3.7 |
| Control Year 2 | Number of Respiratory Adverse Events | 1.2 Number events per subject | Standard Deviation 1.1 |
| Control Year 3 | Number of Respiratory Adverse Events | 1.3 Number events per subject | Standard Deviation 1.6 |