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Bronchial Thermoplasty in Severe Persistent Asthma
NA trial testing Alair System in Severe Asthma in 284 participants. Completed in 17 March 2020.
| Lead sponsor | Boston Scientific Corporation |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 284 |
| Start date | 7 April 2011 |
| Primary completion | 12 November 2019 |
| Estimated completion | 17 March 2020 |
| Sites | 27 locations across Canada, United States |
Boston Scientific Corporation — full company profile →
Adults 18 to 65, any sex, with Severe Asthma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Year 1 | 132 | |
| Year 2 | 118 | |
| Year 3 | 118 | |
| Year 4 | 106 | |
| Year 5 | 97 |
\# Severe exacerbations / subject / year
| Group | Value | 95% CI |
|---|---|---|
| Year 1 | 0.93 | ± 1.35 |
| Year 2 | .92 | ± 1.21 |
| Year 3 | .77 | ± 1.01 |
| Year 4 | .84 | ± 1.23 |
| Year 5 | .72 | ± 1.13 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Year 1 | 1.70 | ± 1.95 |
| Year 2 | 1.52 | ± 1.66 |
| Year 3 | 1.28 | ± 1.42 |
| Year 4 | 1.35 | ± 1.63 |
| Year 5 | 1.22 | ± 1.92 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Year 1 | 184 | |
| Year 2 | 165 | |
| Year 3 | 155 | |
| Year 4 | 141 | |
| Year 5 | 133 |
Emergency room visits for respiratory symptoms (rates of emergency room visits)
| Group | Value | 95% CI |
|---|---|---|
| Year 1 | .31 | ± .87 |
| Year 2 | .24 | ± .80 |
| Year 3 | .21 | ± .65 |
| Year 4 | .17 | ± .56 |
| Year 5 | .13 | ± 0.49 |
Subjects with Emergency room visits for respiratory symptoms
| Group | Value | 95% CI |
|---|---|---|
| Year 1 | 48 | |
| Year 2 | 37 | |
| Year 3 | 32 | |
| Year 4 | 28 | |
| Year 5 | 18 |
(# hospitalizations for respiratory symptoms / subject / year)
| Group | Value | 95% CI |
|---|---|---|
| Year 1 | 0.13 | ± 0.50 |
| Year 2 | 0.11 | ± 0.47 |
| Year 3 | 0.11 | ± 0.47 |
| Year 4 | 0.05 | ± 0.28 |
| Year 5 | 0.06 | ± 0.31 |
Subjects with hospitalizations for respiratory symptoms
| Group | Value | 95% CI |
|---|---|---|
| Year 1 | 21 | |
| Year 2 | 19 | |
| Year 3 | 18 | |
| Year 4 | 8 | |
| Year 5 | 11 |
The rate of subjects with respiratory serious adverse events (SAEs)
| Group | Value | 95% CI |
|---|---|---|
| Year 1 | 0.14 | ± 0.50 |
| Year 2 | 0.11 | ± 0.37 |
| Year 3 | 0.10 | ± 0.41 |
| Year 4 | 0.06 | ± 0.33 |
| Year 5 | 0.06 | ± 0.28 |
Subjects with Respiratory Serious Adverse Events
| Group | Value | 95% CI |
|---|---|---|
| Year 1 | 26 | |
| Year 2 | 25 | |
| Year 3 | 17 | |
| Year 4 | 10 | |
| Year 5 | 11 |
% Predicted Pre-bronchodilator FEV1
| Group | Value | 95% CI |
|---|---|---|
| Year 1 | 89.6 | ± 14.5 |
| Year 2 | 89.3 | ± 14.6 |
| Year 3 | 87.7 | ± 14.9 |
| Year 4 | 88.5 | ± 13.8 |
| Year 5 | 87.4 | ± 14.6 |
% Predicted Post-bronchodilator FEV1
| Group | Value | 95% CI |
|---|---|---|
| Year 1 | 93.1 | ± 13.9 |
| Year 2 | 92.3 | ± 14.1 |
| Year 3 | 91.8 | ± 14.2 |
| Year 4 | 91.1 | ± 14.4 |
| Year 5 | 91.0 | ± 14.3 |
Time frame: 5 Years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Alair |
|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | — |
| Pneumonia | Infections and infestations | — |
| Procedural pain | Injury, poisoning and procedural complications | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Bronchitis | Infections and infestations | — |
| Influenza | Infections and infestations | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — |
| Non-cardiac chest pain | General disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Chest pain | General disorders | — |
| Hiatus hernia | Gastrointestinal disorders | — |
| Diverticulitis | Infections and infestations | — |
| Vocal cord disorder | Respiratory, thoracic and mediastinal disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Angina unstable | Cardiac disorders | — |
| Delivery | Pregnancy, puerperium and perinatal conditions | — |
| Pyelonephritis | Infections and infestations | — |
| Laceration | Injury, poisoning and procedural complications | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| Cellulitis | Infections and infestations | — |
| Myocardial infarction | Cardiac disorders | — |
| Gastrointestinal viral infection | Infections and infestations | — |
| Depression | Psychiatric disorders | — |
| Arthritis | Musculoskeletal and connective tissue disorders | — |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Alair |
|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Bronchitis | Infections and infestations | — |
| Sinusitis | Infections and infestations | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Acute sinusitis | Infections and infestations | — |
| Oral candidiasis | Infections and infestations | — |
| Wheezing | Respiratory, thoracic and mediastinal disorders | — |
| Influenza | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Chest pain | General disorders | — |
| Nasopharyngitis | Infections and infestations | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Headache | Nervous system disorders | — |
| Lower respiratory tract infection | Infections and infestations | — |
| Nausea | Gastrointestinal disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — |
| Hypertension | Vascular disorders | — |
| Hypersensitivity | Immune system disorders | — |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | — |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | — |
| Chest discomfort | General disorders | — |
Most-reported serious reactions: Asthma, Pneumonia, Procedural pain, Arthralgia, Bronchitis, Influenza, Pulmonary embolism, Non-cardiac chest pain.
Data from ClinicalTrials.gov NCT01350336 adverse events section.
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.
5 peer-reviewed publications reference this trial (live from Europe PMC):
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