An observational study in Asthma, sponsored by Boston Scientific Corporation. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-09-26.
Sponsored by Boston Scientific Corporation · Observational
The objective of this study is to evaluate durability of effectiveness (beyond one year) of the Alair System in patients with severe persistent asthma. The study will consist of Alair-group subjects who are currently in the follow-up phase (out to 5 years) of the AIR2 Trial (Protocol #04-02, clinicaltrials.gov number NCT00231114).
Durability of the treatment effect will be evaluated by comparing the proportion of subjects who experience severe exacerbations during the first year after Alair treatment with the proportion of subjects who experience severe exacerbations during subsequent 12 month periods out to 5 years.
All Alair group subjects in the AIR2 Trial are being followed out to 5 years as per the AIR2 Trial protocol. The data that are to be used to determine durability of effectiveness as described in the present protocol (Protocol #10-01) are being collected under the existing AIR2 Trial protocol (Protocol # 04-02).
Study Hypothesis: An empirical demonstration of the durability of the treatment effect will be used to show that the proportion of subjects experiencing severe exacerbations for the first year compared with the proportions of subjects experiencing severe exacerbations in subsequent years do not get substantially worse.
The primary statistical objective is to demonstrate that the proportion of subjects who experience severe exacerbations in the subsequent 12-month follow-up (for Year 2, Year 3, Year 4 and Year 5 [in 12-month periods]) is not statistically worse when compared with the proportion of first 12-months, which begins 6-weeks after the last Alair treatment. This objective will be met if the upper 95% confidence limit of the difference in proportions (i.e., the subsequent 12-month proportion minus the first 12-month proportion) is less than 20%.
This will be an open-label, single arm study designed to demonstrate the durability of effectiveness (beyond one year) of the Alair System in patients with severe persistent asthma.
Durability of treatment effect will be evaluated by comparison of the proportion of subjects experiencing severe exacerbations during the first year after the Alair treatment to subsequent 12-month periods out to 5 years.
The 12-month periods will begin 6 weeks post-last Alair bronchoscopy.
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.
All Alair group subjects who have participated in the AIR2 Trial (NCT00231114) and were not lost to follow-up at the end of the 12 month premarket visit, and those who are willing to comply with the study protocol and routine visits for the duration of the study will be included in the post-approval study.
Exclusion Criteria:
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02, NCT00231114)
Device: Bronchial Thermoplasty with the Alair System
Bronchial Thermoplasty with the Alair System
Severe Exacerbations
The primary endpoint will be the proportion of subjects experiencing severe exacerbations during the first year after the Alair treatment compared to subsequent 12-month periods out to 5 years. This objective will be met if the upper 95% confidence limit of the difference in proportions (i.e., the subsequent 12-month proportion minus the first 12-month proportion) is less than 20%. Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02).
Time frame: 12 month periods out to 5 Years
Severe Exacerbations
Number of severe exacerbations per subject per year. Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02).
Time frame: 12 Month periods out to 5 years
Respiratory Adverse Events
Number of respiratory adverse events per subject per year. 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.
Time frame: 12 Month periods out to 5 years
Respiratory Adverse Events
Proportion of subjects experiencing one or more respiratory adverse event in each of the years 1 through 5 following the Alair treatment. 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.
Time frame: 12 Month periods out to 5 years
Emergency Room Visits for Respiratory Symptoms
Proportion of Subjects with Emergency Room Visits for Respiratory Symptoms
Time frame: 12 Month periods out to 5 years
Emergency Room (ER) Visits for Respiratory Symptoms
Number of Emergency Room Visits for Respiratory Symptoms per subject per year.
Time frame: 12 Month periods out to 5 years
Hospitalizations for Respiratory Symptoms
Proportion of subjects with hospitalizations for respiratory symptoms.
Time frame: 12 Month periods out to 5 Years
Hospitalizations for Respiratory Symptoms
Number of Hospitalizations for Respiratory Symptoms per subject per year.
Time frame: 12 Month periods out to 5 years
Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Pre-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.
Time frame: 12 Month periods out to 5 years
Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Post-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.
Time frame: 12 Month periods out to 5 years
| Milestone | Alair Group |
|---|---|
| Started | 181 |
| Year 2 | 165 |
| Year 3 | 162 |
| Year 4 | 159 |
| Year 5 | 162 |
| Completed | 162 |
| Not completed | 19 |
| Withdrew: Lost to follow-up | 13 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Physician decision | 2 |
The primary endpoint will be the proportion of subjects experiencing severe exacerbations during the first year after the Alair treatment compared to subsequent 12-month periods out to 5 years. This objective will be met if the upper 95% confidence limit of the difference in proportions (i.e., the subsequent 12-month proportion minus the first 12-month proportion) is less than 20%. Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02).
| Percentage subjects severe exacerbations | Alair Group |
|---|---|
| Year 1 | 30.9 (24.2 to 37.7) |
| Year 2 | 23.6 (17.2 to 30.1) |
| Year 3 | 34 (26.7 to 41.2) |
| Year 4 | 36.5 (29 to 44) |
| Year 5 | 21.6 (15.3 to 27.9) |
Number of severe exacerbations per subject per year. Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02).
| Number of events/Number of subjects/Year | Alair Group |
|---|---|
| Year 1 | 0.486 (0.385 to 0.614) |
| Year 2 | 0.406 (0.311 to 0.531) |
| Year 3 | 0.549 (0.435 to 0.693) |
| Year 4 | 0.560 (0.444 to 0.706) |
| Year 5 | 0.309 (0.226 to 0.421) |
Number of respiratory adverse events per subject per year. 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.
| Number of events/number of subject/Year | Alair Group |
|---|---|
| Year 1 | 2.022 (1.764 to 2.318) |
| Year 2 | 1.218 (1.013 to 1.465) |
| Year 3 | 1.247 (1.037 to 1.499) |
| Year 4 | 1.176 (0.971 to 1.424) |
| Year 5 | 0.778 (0.616 to 0.982) |
Proportion of subjects experiencing one or more respiratory adverse event in each of the years 1 through 5 following the Alair treatment. 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.
| Percentage subjects with respiratory AE | Alair Group |
|---|---|
| Year 1 | 72.9 (66.5 to 79.4) |
| Year 2 | 58.8 (51.3 to 66.3) |
| Year 3 | 58 (50.4 to 65.6) |
| Year 4 | 54.7 (47 to 62.5) |
| Year 5 | 47.5 (39.8 to 55.2) |
Proportion of Subjects with Emergency Room Visits for Respiratory Symptoms
| Percentage subjects ER respir. symptoms | Alair Group |
|---|---|
| Year 1 | 5 (1.8 to 8.1) |
| Year 2 | 6.7 (2.9 to 10.5) |
| Year 3 | 8 (3.8 to 12.2) |
| Year 4 | 6.9 (3 to 10.9) |
| Year 5 | 5.6 (2 to 9.1) |
Number of Emergency Room Visits for Respiratory Symptoms per subject per year.
| Number of events/subject/year | Alair Group |
|---|---|
| Year 1 | 0.072 (0.048 to 0.107) |
| Year 2 | 0.085 (0.058 to 0.124) |
| Year 3 | 0.136 (0.100 to 0.184) |
| Year 4 | 0.094 (0.065 to 0.136) |
| Year 5 | 0.068 (0.044 to 0.104) |
Proportion of subjects with hospitalizations for respiratory symptoms.
| Percentage of subjects hospitalized | Alair Group |
|---|---|
| Year 1 | 3.3 (0.7 to 5.9) |
| Year 2 | 4.2 (1.2 to 7.3) |
| Year 3 | 6.2 (2.5 to 9.9) |
| Year 4 | 5.7 (2.1 to 9.3) |
| Year 5 | 1.9 (0.0 to 3.9) |
Number of Hospitalizations for Respiratory Symptoms per subject per year.
| Number of events/subjects/year | Alair Group |
|---|---|
| Year 1 | 0.039 (0.025 to 0.060) |
| Year 2 | 0.061 (0.042 to 0.087) |
| Year 3 | 0.068 (0.048 to 0.096) |
| Year 4 | 0.075 (0.054 to 0.105) |
| Year 5 | 0.025 (0.014 to 0.044) |
Pre-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.
| Percentage of change from Baseline | Alair Group |
|---|---|
| Year 1 | -1.4 ± 14.82 |
| Year 2 | -4.6 ± 15.36 |
| Year 3 | -2.7 ± 15.33 |
| Year 4 | -1.2 ± 14.60 |
| Year 5 | -1.2 ± 16.33 |
Post-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.
| Percentage of change from Baseline | Alair Group |
|---|---|
| Year 1 | -2.8 ± 10.67 |
| Year 2 | -5.4 ± 11.51 |
| Year 3 | -4 ± 12.88 |
| Year 4 | -3.7 ± 11.65 |
| Year 5 | -3.8 ± 11.95 |
Collected over 12 months out to 5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Year 1 | — | 5/187 (2.7%) | 112/187 (59.9%) |
| Year 2 | — | 8/168 (4.8%) | 89/168 (53%) |
| Year 3 | — | 10/163 (6.1%) | 81/163 (49.7%) |
| Year 4 | — | 9/163 (5.5%) | 77/163 (47.2%) |
| Year 5 | — | 3/162 (1.9%) | 61/162 (37.7%) |
| Event | Year 1 | Year 2 | Year 3 | Year 4 | Year 5 |
|---|---|---|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 4/187 | 6/168 | 7/163 | 6/163 | 2/162 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 2/187 | 0/168 | 3/163 | 0/163 | 0/162 |
| CholelithiasisHepatobiliary disorders | 0/187 | 0/168 | 2/163 | 0/163 | 1/162 |
| Angina unstableCardiac disorders | 0/187 | 0/168 | 0/163 | 0/163 | 1/162 |
| Abscess limbInfections and infestations | 0/187 | 0/168 | 0/163 | 0/163 | 1/162 |
| Road traffic accidentInjury, poisoning and procedural complications | 1/187 | 0/168 | 0/163 | 0/163 | 1/162 |
| BronchitisRespiratory, thoracic and mediastinal disorders | 0/187 | 0/168 | 0/163 | 0/163 | 1/162 |
| Angina pectorisCardiac disorders | 0/187 | 0/168 | 0/163 | 1/163 | 0/162 |
| Supraventricular tachycardiaCardiac disorders | 0/187 | 0/168 | 0/163 | 1/163 | 0/162 |
| Addison's diseaseEndocrine disorders | 0/187 | 0/168 | 0/163 | 1/163 | 0/162 |
| Event | Year 1 | Year 2 | Year 3 | Year 4 | Year 5 |
|---|---|---|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 52/187 | 47/168 | 48/163 | 51/163 | 40/162 |
| Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 57/187 | 24/168 | 24/163 | 23/163 | 18/162 |
| NasopharyngitisRespiratory, thoracic and mediastinal disorders | 21/187 | 9/168 | 6/163 | 6/163 | 1/162 |
| SinusitisRespiratory, thoracic and mediastinal disorders | 12/187 | 16/168 | 11/163 | 9/163 | 6/162 |
| Lower respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 7/187 | 9/168 | 11/163 | 15/163 | 6/162 |
| BronchitisRespiratory, thoracic and mediastinal disorders | 14/187 | 12/168 | 8/163 | 6/163 | 5/162 |
| Viral upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 11/187 | 6/168 | 1/163 | 1/163 | 3/162 |
AIR2 Extension Subjects Completing Follow-up at Year 1
| Age, Continuous(years) | Alair Group |
|---|---|
| Mean | 40.8 ± 11.81 |
| Sex: Female, Male(Participants) | Alair Group |
|---|---|
| Female | 102 |
| Male | 79 |
| Region of Enrollment(participants) | Alair Group |
|---|---|
| Brazil | 54 |
| Canada | 34 |
| United States | 54 |
| Australia | 7 |
| United Kingdom | 27 |
| Netherlands | 5 |
| Height (cm)(cm) | Alair Group |
|---|---|
| Mean | 166.8 ± 8.94 |
| Weight (kg)(kg) | Alair Group |
|---|---|
| Mean | 81.9 ± 17.95 |
| ICS Dose (Inhaled Corticosteroid dose)(mcg/day (micrograms/day)) | Alair Group |
|---|---|
| Mean | 1943.9 ± 722.39 |
| LABA Dose (Long-acting Beta Agonists)(mcg/day) | Alair Group |
|---|---|
| Mean | 119.2 ± 45.64 |
| OCS Dose (Oral corticosteroids)(mg/day) | Alair Group |
|---|---|
| Mean | 6.4 ± 1.97 |
4 further baseline measures are reported on the registry.
No study locations are listed for this record.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Boston Scientific Corporation