Trial Outcomes & Findings for Bronchial Thermoplasty in Severe Persistent Asthma (NCT NCT01350336)
NCT ID: NCT01350336
Last Updated: 2021-03-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
284 participants
Primary outcome timeframe
Year 1 vs. Year 2, 3, 4, 5
Results posted on
2021-03-05
Participant Flow
Unit of analysis: Procedure
Participant milestones
| Measure |
Alair
Participants consented for treatment with Alair
|
|---|---|
|
Overall Study
STARTED
|
284 279
|
|
Overall Study
COMPLETED
|
227 227
|
|
Overall Study
NOT COMPLETED
|
57 52
|
Reasons for withdrawal
| Measure |
Alair
Participants consented for treatment with Alair
|
|---|---|
|
Overall Study
Lost to Follow-up
|
31
|
|
Overall Study
Withdrawal by Subject
|
14
|
|
Overall Study
Physician Decision
|
8
|
|
Overall Study
Death
|
4
|
Baseline Characteristics
Bronchial Thermoplasty in Severe Persistent Asthma
Baseline characteristics by cohort
| Measure |
Alair
n=279 Participants
Alair system
Alair System: Treatment of airways with the Alair System
|
|---|---|
|
Age, Continuous
|
45.71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
180 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, of African Heritage
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
234 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
|
Height
|
167.4 cm
n=5 Participants
|
|
Weight
|
90.3 kg
n=5 Participants
|
|
BMI
|
32.2 kg/m2
n=5 Participants
|
|
AQLQ
|
4.03 AQLQ Score
STANDARD_DEVIATION 1.28 • n=5 Participants
|
|
FEV1 - % Predicted
Pre-bronchodilator FEV1
|
80.4 % Predicted
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
FEV1 - % Predicted
Post-bronchodilator FEV1
|
85.8 % Predicted
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Prior 12 months - % Subjects
Severe Exacerbations
|
217 Participants
n=5 Participants
|
|
Prior 12 months - % Subjects
Hospitalization for asthma
|
45 Participants
n=5 Participants
|
|
Prior 12 months - % Subjects
ER visits for asthma
|
82 Participants
n=5 Participants
|
|
Prior 12 months - Event rates
Severe Exacerbations
|
1.61 # events / subject
STANDARD_DEVIATION 1.12 • n=5 Participants
|
|
Prior 12 months - Event rates
Hospitalizations for asthma
|
0.22 # events / subject
STANDARD_DEVIATION 0.53 • n=5 Participants
|
|
Prior 12 months - Event rates
ER visits for asthma
|
0.54 # events / subject
STANDARD_DEVIATION 1.20 • n=5 Participants
|
PRIMARY outcome
Timeframe: Year 1 vs. Year 2, 3, 4, 5Population: Primary Endpoint - 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.
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.
Outcome measures
| Measure |
Year 1
n=262 Participants
Proportion of Severe Exacerbations at Year 1
|
Year 2
n=252 Participants
Proportion of Severe Exacerbations at Year 2
|
Year 3
n=247 Participants
Proportion of Severe Exacerbations at Year 3
|
Year 4
n=240 Participants
Proportion of Severe Exacerbations at Year 4
|
Year 5
n=227 Participants
Proportion of Severe Exacerbations at Year 5
|
|---|---|---|---|---|---|
|
Subjects Experiencing Severe Exacerbations (Rates)
|
132 Participants
|
118 Participants
|
118 Participants
|
106 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: Year 1-5\# Severe exacerbations / subject / year
Outcome measures
| Measure |
Year 1
n=262 Participants
Proportion of Severe Exacerbations at Year 1
|
Year 2
n=252 Participants
Proportion of Severe Exacerbations at Year 2
|
Year 3
n=247 Participants
Proportion of Severe Exacerbations at Year 3
|
Year 4
n=240 Participants
Proportion of Severe Exacerbations at Year 4
|
Year 5
n=227 Participants
Proportion of Severe Exacerbations at Year 5
|
|---|---|---|---|---|---|
|
Rates of Severe Exacerbations
|
0.93 # Severe Exacerbations / subject / year
Standard Deviation 1.35
|
.92 # Severe Exacerbations / subject / year
Standard Deviation 1.21
|
.77 # Severe Exacerbations / subject / year
Standard Deviation 1.01
|
.84 # Severe Exacerbations / subject / year
Standard Deviation 1.23
|
.72 # Severe Exacerbations / subject / year
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Year 1-5A 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.
Outcome measures
| Measure |
Year 1
n=276 Participants
Proportion of Severe Exacerbations at Year 1
|
Year 2
n=262 Participants
Proportion of Severe Exacerbations at Year 2
|
Year 3
n=250 Participants
Proportion of Severe Exacerbations at Year 3
|
Year 4
n=240 Participants
Proportion of Severe Exacerbations at Year 4
|
Year 5
n=235 Participants
Proportion of Severe Exacerbations at Year 5
|
|---|---|---|---|---|---|
|
Respiratory Adverse Event Rates
|
1.70 # Resp. AE / subject / year
Standard Deviation 1.95
|
1.52 # Resp. AE / subject / year
Standard Deviation 1.66
|
1.28 # Resp. AE / subject / year
Standard Deviation 1.42
|
1.35 # Resp. AE / subject / year
Standard Deviation 1.63
|
1.22 # Resp. AE / subject / year
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: Year 1-5A 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.
Outcome measures
| Measure |
Year 1
n=276 Participants
Proportion of Severe Exacerbations at Year 1
|
Year 2
n=262 Participants
Proportion of Severe Exacerbations at Year 2
|
Year 3
n=250 Participants
Proportion of Severe Exacerbations at Year 3
|
Year 4
n=240 Participants
Proportion of Severe Exacerbations at Year 4
|
Year 5
n=235 Participants
Proportion of Severe Exacerbations at Year 5
|
|---|---|---|---|---|---|
|
Subjects With Respiratory Adverse Events
|
184 Participants
|
165 Participants
|
155 Participants
|
141 Participants
|
133 Participants
|
SECONDARY outcome
Timeframe: Year 1-5Emergency room visits for respiratory symptoms (rates of emergency room visits)
Outcome measures
| Measure |
Year 1
n=262 Participants
Proportion of Severe Exacerbations at Year 1
|
Year 2
n=252 Participants
Proportion of Severe Exacerbations at Year 2
|
Year 3
n=247 Participants
Proportion of Severe Exacerbations at Year 3
|
Year 4
n=240 Participants
Proportion of Severe Exacerbations at Year 4
|
Year 5
n=227 Participants
Proportion of Severe Exacerbations at Year 5
|
|---|---|---|---|---|---|
|
Emergency Room Visits for Respiratory Symptoms Rates
|
.31 # ER Visit / subject / year
Standard Deviation .87
|
.24 # ER Visit / subject / year
Standard Deviation .80
|
.21 # ER Visit / subject / year
Standard Deviation .65
|
.17 # ER Visit / subject / year
Standard Deviation .56
|
.13 # ER Visit / subject / year
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Year 1-5Subjects with Emergency room visits for respiratory symptoms
Outcome measures
| Measure |
Year 1
n=262 Participants
Proportion of Severe Exacerbations at Year 1
|
Year 2
n=252 Participants
Proportion of Severe Exacerbations at Year 2
|
Year 3
n=247 Participants
Proportion of Severe Exacerbations at Year 3
|
Year 4
n=240 Participants
Proportion of Severe Exacerbations at Year 4
|
Year 5
n=227 Participants
Proportion of Severe Exacerbations at Year 5
|
|---|---|---|---|---|---|
|
Subjects With Emergency Room Visits for Respiratory Symptoms
|
48 Participants
|
37 Participants
|
32 Participants
|
28 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Year 1-5(# hospitalizations for respiratory symptoms / subject / year)
Outcome measures
| Measure |
Year 1
n=262 Participants
Proportion of Severe Exacerbations at Year 1
|
Year 2
n=252 Participants
Proportion of Severe Exacerbations at Year 2
|
Year 3
n=247 Participants
Proportion of Severe Exacerbations at Year 3
|
Year 4
n=240 Participants
Proportion of Severe Exacerbations at Year 4
|
Year 5
n=227 Participants
Proportion of Severe Exacerbations at Year 5
|
|---|---|---|---|---|---|
|
Hospitalizations for Respiratory Symptoms Rates
|
0.13 # Hospitalizations / subject / year
Standard Deviation 0.50
|
0.11 # Hospitalizations / subject / year
Standard Deviation 0.47
|
0.11 # Hospitalizations / subject / year
Standard Deviation 0.47
|
0.05 # Hospitalizations / subject / year
Standard Deviation 0.28
|
0.06 # Hospitalizations / subject / year
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Year 1-5Subjects with hospitalizations for respiratory symptoms
Outcome measures
| Measure |
Year 1
n=262 Participants
Proportion of Severe Exacerbations at Year 1
|
Year 2
n=252 Participants
Proportion of Severe Exacerbations at Year 2
|
Year 3
n=247 Participants
Proportion of Severe Exacerbations at Year 3
|
Year 4
n=240 Participants
Proportion of Severe Exacerbations at Year 4
|
Year 5
n=227 Participants
Proportion of Severe Exacerbations at Year 5
|
|---|---|---|---|---|---|
|
Subjects With Hospitalizations for Respiratory Symptoms
|
21 Participants
|
19 Participants
|
18 Participants
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Year 1-5The rate of subjects with respiratory serious adverse events (SAEs)
Outcome measures
| Measure |
Year 1
n=276 Participants
Proportion of Severe Exacerbations at Year 1
|
Year 2
n=262 Participants
Proportion of Severe Exacerbations at Year 2
|
Year 3
n=250 Participants
Proportion of Severe Exacerbations at Year 3
|
Year 4
n=240 Participants
Proportion of Severe Exacerbations at Year 4
|
Year 5
n=235 Participants
Proportion of Severe Exacerbations at Year 5
|
|---|---|---|---|---|---|
|
Respiratory Serious Adverse Events Rates
|
0.14 # Respiratory SAEs / subect / year
Standard Deviation 0.50
|
0.11 # Respiratory SAEs / subect / year
Standard Deviation 0.37
|
0.10 # Respiratory SAEs / subect / year
Standard Deviation 0.41
|
0.06 # Respiratory SAEs / subect / year
Standard Deviation 0.33
|
0.06 # Respiratory SAEs / subect / year
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Year 1-5Subjects with Respiratory Serious Adverse Events
Outcome measures
| Measure |
Year 1
n=276 Participants
Proportion of Severe Exacerbations at Year 1
|
Year 2
n=262 Participants
Proportion of Severe Exacerbations at Year 2
|
Year 3
n=250 Participants
Proportion of Severe Exacerbations at Year 3
|
Year 4
n=240 Participants
Proportion of Severe Exacerbations at Year 4
|
Year 5
n=235 Participants
Proportion of Severe Exacerbations at Year 5
|
|---|---|---|---|---|---|
|
Subjects With Respiratory Serious Adverse Events
|
26 Participants
|
25 Participants
|
17 Participants
|
10 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Year 1-5% Predicted Pre-bronchodilator FEV1
Outcome measures
| Measure |
Year 1
n=258 Participants
Proportion of Severe Exacerbations at Year 1
|
Year 2
n=235 Participants
Proportion of Severe Exacerbations at Year 2
|
Year 3
n=235 Participants
Proportion of Severe Exacerbations at Year 3
|
Year 4
n=212 Participants
Proportion of Severe Exacerbations at Year 4
|
Year 5
n=217 Participants
Proportion of Severe Exacerbations at Year 5
|
|---|---|---|---|---|---|
|
Pre-bronchodilator FEV1
|
89.6 % Predicted
Standard Deviation 14.5
|
89.3 % Predicted
Standard Deviation 14.6
|
87.7 % Predicted
Standard Deviation 14.9
|
88.5 % Predicted
Standard Deviation 13.8
|
87.4 % Predicted
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: Year 1-5% Predicted Post-bronchodilator FEV1
Outcome measures
| Measure |
Year 1
n=257 Participants
Proportion of Severe Exacerbations at Year 1
|
Year 2
n=233 Participants
Proportion of Severe Exacerbations at Year 2
|
Year 3
n=229 Participants
Proportion of Severe Exacerbations at Year 3
|
Year 4
n=212 Participants
Proportion of Severe Exacerbations at Year 4
|
Year 5
n=213 Participants
Proportion of Severe Exacerbations at Year 5
|
|---|---|---|---|---|---|
|
Post-bronchodilator FEV1
|
93.1 % Predicted
Standard Deviation 13.9
|
92.3 % Predicted
Standard Deviation 14.1
|
91.8 % Predicted
Standard Deviation 14.2
|
91.1 % Predicted
Standard Deviation 14.4
|
91.0 % Predicted
Standard Deviation 14.3
|
Adverse Events
Alair
Serious events: 130 serious events
Other events: 268 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Alair
n=279 participants at risk
Alair system
Alair System: Treatment of airways with the Alair System
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
20.8%
58/279 • Number of events 135 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Pneumonia
|
3.6%
10/279 • Number of events 12 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
6/279 • Number of events 7 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.5%
7/279 • Number of events 7 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Influenza
|
1.8%
5/279 • Number of events 7 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Bronchitis
|
2.2%
6/279 • Number of events 6 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
4/279 • Number of events 5 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
General disorders
Non-cardiac chest pain
|
1.4%
4/279 • Number of events 4 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
3/279 • Number of events 4 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
General disorders
Chest pain
|
1.1%
3/279 • Number of events 3 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.1%
3/279 • Number of events 3 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Diverticulitis
|
1.1%
3/279 • Number of events 3 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
1.1%
3/279 • Number of events 3 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.72%
2/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Cardiac disorders
Angina unstable
|
0.72%
2/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Pregnancy, puerperium and perinatal conditions
Delivery
|
0.72%
2/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Pyelonephritis
|
0.72%
2/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.72%
2/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.36%
1/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.36%
1/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.36%
1/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.72%
2/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Cellulitis
|
0.72%
2/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Cardiac disorders
Myocardial infarction
|
0.72%
2/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.72%
2/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Psychiatric disorders
Depression
|
0.72%
2/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.72%
2/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.72%
2/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.36%
1/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Lung abscess
|
0.72%
2/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Vascular disorders
Deep vein thrombosis
|
0.72%
2/279 • Number of events 2 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
General disorders
Adverse drug reaction
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Tooth malformation
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Tinea pedis
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Surgical and medical procedures
Hysterectomy
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Surgical and medical procedures
Abdominal hernia repair
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Skin and subcutaneous tissue disorders
Excessive skin
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Osteomyelitis
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Surgical and medical procedures
Cardiac ablation
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Pneumonia viral
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Cardiac disorders
Cardiac failure
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Endocrine disorders
Goitre
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Nausea
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Urosepsis
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Volvulus
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Localised infection
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Kidney infection
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Herpes simplex
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Reproductive system and breast disorders
Cystocele
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Gastroenteritis viral
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Psychiatric disorders
Anxiety
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Pregnancy, puerperium and perinatal conditions
Blighted ovum
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Nervous system disorders
Sciatica
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Nervous system disorders
Paraparesis
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Nervous system disorders
Loss of consciousness
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Nervous system disorders
Migraine
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Nervous system disorders
Headache
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Nervous system disorders
Convulsion
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Cardiac disorders
Cardiac arrest
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Aspergilloma
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Cardiac disorders
Tachycardia
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Cardiac disorders
Coronary artery disease
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Immune system disorders
Hypersensitivity
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Immune system disorders
Anaphylactic reaction
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
General disorders
Pyrexia
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Surgical and medical procedures
Caesarean section
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Investigations
Blood immunoglobulin G decreased
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Cardiac disorders
Cardiomyopathy
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
General disorders
Death
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.36%
1/279 • Number of events 1 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
Other adverse events
| Measure |
Alair
n=279 participants at risk
Alair system
Alair System: Treatment of airways with the Alair System
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
83.9%
234/279 • Number of events 1258 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Upper respiratory tract infection
|
42.3%
118/279 • Number of events 205 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Bronchitis
|
31.9%
89/279 • Number of events 152 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Sinusitis
|
22.9%
64/279 • Number of events 140 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
54/279 • Number of events 78 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Acute sinusitis
|
17.2%
48/279 • Number of events 80 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Oral candidiasis
|
14.3%
40/279 • Number of events 71 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
14.3%
40/279 • Number of events 63 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Influenza
|
13.6%
38/279 • Number of events 48 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Pneumonia
|
13.3%
37/279 • Number of events 49 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
General disorders
Chest pain
|
11.8%
33/279 • Number of events 40 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
28/279 • Number of events 42 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.6%
24/279 • Number of events 29 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Urinary tract infection
|
8.2%
23/279 • Number of events 41 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Nervous system disorders
Headache
|
7.9%
22/279 • Number of events 28 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Infections and infestations
Lower respiratory tract infection
|
6.8%
19/279 • Number of events 26 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Nausea
|
6.5%
18/279 • Number of events 25 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
18/279 • Number of events 23 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.1%
17/279 • Number of events 21 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Vascular disorders
Hypertension
|
5.7%
16/279 • Number of events 19 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Immune system disorders
Hypersensitivity
|
5.7%
16/279 • Number of events 17 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.4%
15/279 • Number of events 17 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.4%
15/279 • Number of events 18 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
|
General disorders
Chest discomfort
|
5.0%
14/279 • Number of events 17 • 5 Years
Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place