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Bronchial Thermoplasty in Severe Persistent Asthma (PAS2)

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ClinicalTrials.gov Identifier: NCT01350336
Recruitment Status : Completed
First Posted : May 9, 2011
Results First Posted : March 5, 2021
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Severe Asthma
Intervention Device: Alair System
Enrollment 284
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Alair
Hide Arm/Group Description Participants consented for treatment with Alair
Period Title: Overall Study
Number of participants Number of units (Procedure)
Started 284 279
Completed 227 227
Not Completed 57 52
Reason Not Completed
Lost to Follow-up             31            
Withdrawal by Subject             14            
Physician Decision             8            
Death             4            
Arm/Group Title Alair
Hide Arm/Group Description

Alair system

Alair System: Treatment of airways with the Alair System

Overall Number of Baseline Participants 279
Hide Baseline Analysis Population Description
Subjects with at least 1 BT procedure.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 279 participants
45.71
(18 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 279 participants
Female
180
  64.5%
Male
99
  35.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 279 participants
American Indian or Alaska native
3
   1.1%
Asian
4
   1.4%
Black, of African Heritage
25
   9.0%
Caucasian
234
  83.9%
Hispanic or Latino
8
   2.9%
Other
5
   1.8%
Height  
Mean (Full Range)
Unit of measure:  Cm
Number Analyzed 279 participants
167.4
(133 to 195)
Weight  
Mean (Full Range)
Unit of measure:  Kg
Number Analyzed 279 participants
90.3
(49 to 185.5)
BMI  
Mean (Full Range)
Unit of measure:  Kg/m2
Number Analyzed 279 participants
32.2
(18.2 to 61.3)
AQLQ   [1] 
Mean (Standard Deviation)
Unit of measure:  AQLQ Score
Number Analyzed 279 participants
4.03  (1.28)
[1]
Measure Description: There are 32 questions in the Asthma Quality of Life Questionnaire (AQLQ) and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains.
FEV1 - % Predicted  
Mean (Standard Deviation)
Unit of measure:  % Predicted
Number Analyzed 279 participants
Pre-bronchodilator FEV1 80.4  (13.7)
Post-bronchodilator FEV1 85.8  (13.6)
Prior 12 months - % Subjects  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 279 participants
Severe Exacerbations
217
  77.8%
Hospitalization for asthma
45
  16.1%
ER visits for asthma
82
  29.4%
Prior 12 months - Event rates  
Mean (Standard Deviation)
Unit of measure:  # events / subject
Number Analyzed 279 participants
Severe Exacerbations 1.61  (1.12)
Hospitalizations for asthma 0.22  (0.53)
ER visits for asthma 0.54  (1.20)
1.Primary Outcome
Title Subjects Experiencing Severe Exacerbations (Rates)
Hide Description 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.
Time Frame Year 1 vs. Year 2, 3, 4, 5
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Year 1 Year 2 Year 3 Year 4 Year 5
Hide Arm/Group Description:
Proportion of Severe Exacerbations at Year 1
Proportion of Severe Exacerbations at Year 2
Proportion of Severe Exacerbations at Year 3
Proportion of Severe Exacerbations at Year 4
Proportion of Severe Exacerbations at Year 5
Overall Number of Participants Analyzed 262 252 247 240 227
Measure Type: Count of Participants
Unit of Measure: Participants
132
  50.4%
118
  46.8%
118
  47.8%
106
  44.2%
97
  42.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Year 1, Year 2
Comments Comparison of Years 1 and 2
Type of Statistical Test Non-Inferiority
Comments An upper 95% confidence limit of the difference between Year 2 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.
Method of Estimation Estimation Parameter Difference of proportions
Estimated Value -0.0380
Confidence Interval (2-Sided) 95%
-0.1251 to 0.0497
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Year 1, Year 3
Comments Comparison of Years 1 and 3
Type of Statistical Test Non-Inferiority
Comments An upper 95% confidence limit of the difference between Year 3 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.
Method of Estimation Estimation Parameter Difference of proportions
Estimated Value -0.0325
Confidence Interval (2-Sided) 95%
-0.1197 to 0.0565
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Year 1, Year 4
Comments Comparison of Years 1 and 4
Type of Statistical Test Non-Inferiority
Comments An upper 95% confidence limit of the difference between Year 4 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.
Method of Estimation Estimation Parameter Difference of proportions
Estimated Value -0.0566
Confidence Interval (2-Sided) 95%
-0.1444 to 0.0329
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Year 1, Year 5
Comments Comparison of Years 1 and 5
Type of Statistical Test Non-Inferiority
Comments An upper 95% confidence limit of the difference between Year 5 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.
Method of Estimation Estimation Parameter Difference of proportions
Estimated Value -0.0765
Confidence Interval (2-Sided) 95%
-0.1661 to 0.0130
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Rates of Severe Exacerbations
Hide Description # Severe exacerbations / subject / year
Time Frame Year 1-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Year 1 Year 2 Year 3 Year 4 Year 5
Hide Arm/Group Description:
Rates of Severe Exacerbations at Year 1
Rates of Severe Exacerbations at Year 2
Rates of Severe Exacerbations at Year 3
Rates of Severe Exacerbations at Year 4
Rates of Severe Exacerbations at Year 5
Overall Number of Participants Analyzed 262 252 247 240 227
Mean (Standard Deviation)
Unit of Measure: # Severe Exacerbations / subject / year
0.93  (1.35) .92  (1.21) .77  (1.01) .84  (1.23) .72  (1.13)
3.Secondary Outcome
Title Respiratory Adverse Event Rates
Hide Description 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 Year 1-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Year 1 Year 2 Year 3 Year 4 Year 5
Hide Arm/Group Description:
Respiratory adverse events at Year 1
Respiratory adverse events at Year 2
Respiratory adverse events at Year 3
Respiratory adverse events at Year 4
Respiratory adverse events at Year
Overall Number of Participants Analyzed 276 262 250 240 235
Mean (Standard Deviation)
Unit of Measure: # Resp. AE / subject / year
1.70  (1.95) 1.52  (1.66) 1.28  (1.42) 1.35  (1.63) 1.22  (1.92)
4.Secondary Outcome
Title Subjects With Respiratory Adverse Events
Hide Description 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 Year 1-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Year 1 Year 2 Year 3 Year 4 Year 5
Hide Arm/Group Description:
Respiratory adverse events at Year 1
Respiratory adverse events at Year 2
Respiratory adverse events at Year 3
Respiratory adverse events at Year 4
Respiratory adverse events at Year 5
Overall Number of Participants Analyzed 276 262 250 240 235
Measure Type: Count of Participants
Unit of Measure: Participants
184
  66.7%
165
  63.0%
155
  62.0%
141
  58.8%
133
  56.6%
5.Secondary Outcome
Title Emergency Room Visits for Respiratory Symptoms Rates
Hide Description Emergency room visits for respiratory symptoms (rates of emergency room visits)
Time Frame Year 1-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Year 1 Year 2 Year 3 Year 4 Year 5
Hide Arm/Group Description:
Emergency room visits for respiratory symptoms rates at Year 1
Emergency room visits for respiratory symptoms rates at Year 2
Emergency room visits for respiratory symptoms rates at Year 3
Emergency room visits for respiratory symptoms rates at Year 4
Emergency room visits for respiratory symptoms rates at Year 5
Overall Number of Participants Analyzed 262 252 247 240 227
Mean (Standard Deviation)
Unit of Measure: # ER Visit / subject / year
.31  (.87) .24  (.80) .21  (.65) .17  (.56) .13  (0.49)
6.Secondary Outcome
Title Subjects With Emergency Room Visits for Respiratory Symptoms
Hide Description Subjects with Emergency room visits for respiratory symptoms
Time Frame Year 1-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Year 1 Year 2 Year 3 Year 4 Year 5
Hide Arm/Group Description:
Emergency room visits for respiratory symptoms proportions at Year 1
Emergency room visits for respiratory symptoms proportions at Year 2
Emergency room visits for respiratory symptoms proportions at Year 3
Emergency room visits for respiratory symptoms proportions at Year 4
Emergency room visits for respiratory symptoms proportions at Year 5
Overall Number of Participants Analyzed 262 252 247 240 227
Measure Type: Count of Participants
Unit of Measure: Participants
48
  18.3%
37
  14.7%
32
  13.0%
28
  11.7%
18
   7.9%
7.Secondary Outcome
Title Hospitalizations for Respiratory Symptoms Rates
Hide Description (# hospitalizations for respiratory symptoms / subject / year)
Time Frame Year 1-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Year 1 Year 2 Year 3 Year 4 Year 5
Hide Arm/Group Description:
Hospitalizations for respiratory symptoms rates at Year 1
Hospitalizations for respiratory symptoms rates at Year 2
Hospitalizations for respiratory symptoms rates at Year 3
Hospitalizations for respiratory symptoms rates at Year 4
Hospitalizations for respiratory symptoms rates at Year 5
Overall Number of Participants Analyzed 262 252 247 240 227
Mean (Standard Deviation)
Unit of Measure: # Hospitalizations / subject / year
0.13  (0.50) 0.11  (0.47) 0.11  (0.47) 0.05  (0.28) 0.06  (0.31)
8.Secondary Outcome
Title Subjects With Hospitalizations for Respiratory Symptoms
Hide Description Subjects with hospitalizations for respiratory symptoms
Time Frame Year 1-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Year 1 Year 2 Year 3 Year 4 Year 5
Hide Arm/Group Description:
Hospitalizations for respiratory symptoms proportions at Year 1
Hospitalizations for respiratory symptoms proportions at Year 2
Hospitalizations for respiratory symptoms proportions at Year 3
Hospitalizations for respiratory symptoms proportions at Year 4
Hospitalizations for respiratory symptoms proportions at Year 5
Overall Number of Participants Analyzed 262 252 247 240 227
Measure Type: Count of Participants
Unit of Measure: Participants
21
   8.0%
19
   7.5%
18
   7.3%
8
   3.3%
11
   4.8%
9.Secondary Outcome
Title Respiratory Serious Adverse Events Rates
Hide Description The rate of subjects with respiratory serious adverse events (SAEs)
Time Frame Year 1-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Year 1 Year 2 Year 3 Year 4 Year 5
Hide Arm/Group Description:
Respiratory Serious Adverse Events rates at Year 1
Respiratory Serious Adverse Events rates at Year 2
Respiratory Serious Adverse Events rates at Year 3
Respiratory Serious Adverse Events rates at Year 4
Respiratory Serious Adverse Events rates at Year 5
Overall Number of Participants Analyzed 276 262 250 240 235
Mean (Standard Deviation)
Unit of Measure: # Respiratory SAEs / subect / year
0.14  (0.50) 0.11  (0.37) 0.10  (0.41) 0.06  (0.33) 0.06  (0.28)
10.Secondary Outcome
Title Subjects With Respiratory Serious Adverse Events
Hide Description Subjects with Respiratory Serious Adverse Events
Time Frame Year 1-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Year 1 Year 2 Year 3 Year 4 Year 5
Hide Arm/Group Description:
Respiratory Serious Adverse Events proportions at Year 1
Respiratory Serious Adverse Events proportions at Year 2
Respiratory Serious Adverse Events proportions at Year 3
Respiratory Serious Adverse Events proportions at Year 4
Respiratory Serious Adverse Events proportions at Year 5
Overall Number of Participants Analyzed 276 262 250 240 235
Measure Type: Count of Participants
Unit of Measure: Participants
26
   9.4%
25
   9.5%
17
   6.8%
10
   4.2%
11
   4.7%
11.Secondary Outcome
Title Pre-bronchodilator FEV1
Hide Description % Predicted Pre-bronchodilator FEV1
Time Frame Year 1-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Year 1 Year 2 Year 3 Year 4 Year 5
Hide Arm/Group Description:
Respiratory Serious Adverse Events proportions at Year 1
Respiratory Serious Adverse Events proportions at Year 2
Respiratory Serious Adverse Events proportions at Year 3
Respiratory Serious Adverse Events proportions at Year 4
Respiratory Serious Adverse Events proportions at Year 5
Overall Number of Participants Analyzed 258 235 235 212 217
Mean (Standard Deviation)
Unit of Measure: % Predicted
89.6  (14.5) 89.3  (14.6) 87.7  (14.9) 88.5  (13.8) 87.4  (14.6)
12.Secondary Outcome
Title Post-bronchodilator FEV1
Hide Description % Predicted Post-bronchodilator FEV1
Time Frame Year 1-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Year 1 Year 2 Year 3 Year 4 Year 5
Hide Arm/Group Description:
Respiratory Serious Adverse Events proportions at Year 1
Respiratory Serious Adverse Events proportions at Year 2
Respiratory Serious Adverse Events proportions at Year 3
Respiratory Serious Adverse Events proportions at Year 4
Respiratory Serious Adverse Events proportions at Year 5
Overall Number of Participants Analyzed 257 233 229 212 213
Mean (Standard Deviation)
Unit of Measure: % Predicted
93.1  (13.9) 92.3  (14.1) 91.8  (14.2) 91.1  (14.4) 91.0  (14.3)
Time Frame 5 Years
Adverse Event Reporting Description Adverse events were collected from the time of first BT procedure through the 5-year follow-up.
 
Arm/Group Title Alair
Hide Arm/Group Description

Alair system

Alair System: Treatment of airways with the Alair System

All-Cause Mortality
Alair
Affected / at Risk (%)
Total   4/279 (1.43%)    
Hide Serious Adverse Events
Alair
Affected / at Risk (%) # Events
Total   130/279 (46.59%)    
Cardiac disorders   
Atrial fibrillation * 1  3/279 (1.08%)  4
Angina unstable * 1  2/279 (0.72%)  2
Myocardial infarction * 1  2/279 (0.72%)  2
Cardiac failure * 1  1/279 (0.36%)  1
Cardio-respiratory arrest * 1  1/279 (0.36%)  1
Cardiac arrest * 1  1/279 (0.36%)  1
Tachycardia * 1  1/279 (0.36%)  1
Coronary artery disease * 1  1/279 (0.36%)  1
Acute myocardial infarction * 1  1/279 (0.36%)  1
Cardiomyopathy * 1  1/279 (0.36%)  1
Endocrine disorders   
Hyperparathyroidism * 1  1/279 (0.36%)  1
Goitre * 1  1/279 (0.36%)  1
Gastrointestinal disorders   
Hiatus hernia * 1  3/279 (1.08%)  3
Large intestine perforation * 1  1/279 (0.36%)  2
Abdominal hernia * 1  1/279 (0.36%)  1
Tooth malformation * 1  1/279 (0.36%)  1
Oesophageal food impaction * 1  1/279 (0.36%)  1
Nausea * 1  1/279 (0.36%)  1
Pancreatitis * 1  1/279 (0.36%)  1
Volvulus * 1  1/279 (0.36%)  1
Abdominal pain * 1  1/279 (0.36%)  1
Intestinal obstruction * 1  1/279 (0.36%)  1
Gastrooesophageal reflux disease * 1  1/279 (0.36%)  1
Inguinal hernia * 1  1/279 (0.36%)  1
Colitis ulcerative * 1  1/279 (0.36%)  1
Colitis ischaemic * 1  1/279 (0.36%)  1
Oesophageal achalasia * 1  1/279 (0.36%)  1
Abdominal wall haematoma * 1  1/279 (0.36%)  1
General disorders   
Non-cardiac chest pain * 1  4/279 (1.43%)  4
Chest pain * 1  3/279 (1.08%)  3
Adverse drug reaction * 1  1/279 (0.36%)  1
Pyrexia * 1  1/279 (0.36%)  1
Death * 1  1/279 (0.36%)  1
Immune system disorders   
Hypersensitivity * 1  1/279 (0.36%)  1
Anaphylactic reaction * 1  1/279 (0.36%)  1
Infections and infestations   
Pneumonia * 1  10/279 (3.58%)  12
Influenza * 1  5/279 (1.79%)  7
Bronchitis * 1  6/279 (2.15%)  6
Diverticulitis * 1  3/279 (1.08%)  3
Pyelonephritis * 1  2/279 (0.72%)  2
Cellulitis * 1  2/279 (0.72%)  2
Gastrointestinal viral infection * 1  2/279 (0.72%)  2
Lung abscess * 1  2/279 (0.72%)  2
Upper respiratory tract infection * 1  1/279 (0.36%)  1
Tinea pedis * 1  1/279 (0.36%)  1
Osteomyelitis * 1  1/279 (0.36%)  1
Pneumonia viral * 1  1/279 (0.36%)  1
Lower respiratory tract infection * 1  1/279 (0.36%)  1
Urosepsis * 1  1/279 (0.36%)  1
Localised infection * 1  1/279 (0.36%)  1
Kidney infection * 1  1/279 (0.36%)  1
Herpes simplex * 1  1/279 (0.36%)  1
Gastroenteritis viral * 1  1/279 (0.36%)  1
Beta haemolytic streptococcal infection * 1  1/279 (0.36%)  1
Aspergilloma * 1  1/279 (0.36%)  1
Pelvic inflammatory disease * 1  1/279 (0.36%)  1
Injury, poisoning and procedural complications   
Procedural pain * 1  7/279 (2.51%)  7
Laceration * 1  2/279 (0.72%)  2
Overdose * 1  1/279 (0.36%)  1
Ligament rupture * 1  1/279 (0.36%)  1
Joint injury * 1  1/279 (0.36%)  1
Multiple fractures * 1  1/279 (0.36%)  1
Upper limb fracture * 1  1/279 (0.36%)  1
Rib fracture * 1  1/279 (0.36%)  1
Investigations   
Blood immunoglobulin G decreased * 1  1/279 (0.36%)  1
Metabolism and nutrition disorders   
Diabetes mellitus * 1  1/279 (0.36%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  6/279 (2.15%)  7
Back pain * 1  2/279 (0.72%)  2
Arthritis * 1  2/279 (0.72%)  2
Osteonecrosis * 1  1/279 (0.36%)  1
Osteoarthritis * 1  1/279 (0.36%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer * 1  1/279 (0.36%)  1
Adrenal adenoma * 1  1/279 (0.36%)  1
Nervous system disorders   
Transient ischaemic attack * 1  1/279 (0.36%)  1
Sciatica * 1  1/279 (0.36%)  1
Paraparesis * 1  1/279 (0.36%)  1
Loss of consciousness * 1  1/279 (0.36%)  1
Migraine * 1  1/279 (0.36%)  1
Headache * 1  1/279 (0.36%)  1
Convulsion * 1  1/279 (0.36%)  1
Cerebrovascular accident * 1  1/279 (0.36%)  1
Pregnancy, puerperium and perinatal conditions   
Delivery * 1  2/279 (0.72%)  2
Blighted ovum * 1  1/279 (0.36%)  1
Psychiatric disorders   
Bipolar I disorder * 1  1/279 (0.36%)  2
Depression * 1  2/279 (0.72%)  2
Anxiety * 1  1/279 (0.36%)  1
Reproductive system and breast disorders   
Cystocele * 1  1/279 (0.36%)  1
Pelvic prolapse * 1  1/279 (0.36%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  58/279 (20.79%)  135
Pulmonary embolism * 1  4/279 (1.43%)  5
Vocal cord disorder * 1  3/279 (1.08%)  3
Acute respiratory failure * 1  1/279 (0.36%)  2
Haemoptysis * 1  2/279 (0.72%)  2
Atelectasis * 1  2/279 (0.72%)  2
Status asthmaticus * 1  1/279 (0.36%)  1
Bronchospasm * 1  1/279 (0.36%)  1
Skin and subcutaneous tissue disorders   
Eczema * 1  1/279 (0.36%)  2
Excessive skin * 1  1/279 (0.36%)  1
Surgical and medical procedures   
Hysterectomy * 1  1/279 (0.36%)  1
Abdominal hernia repair * 1  1/279 (0.36%)  1
Cardiac ablation * 1  1/279 (0.36%)  1
Caesarean section * 1  1/279 (0.36%)  1
Hip arthroplasty * 1  1/279 (0.36%)  1
Vascular disorders   
Deep vein thrombosis * 1  2/279 (0.72%)  2
1
Term from vocabulary, MedDRA (17.1)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alair
Affected / at Risk (%) # Events
Total   268/279 (96.06%)    
Gastrointestinal disorders   
Nausea * 1  18/279 (6.45%)  25
Gastrooesophageal reflux disease * 1  17/279 (6.09%)  21
General disorders   
Chest pain * 1  33/279 (11.83%)  40
Chest discomfort * 1  14/279 (5.02%)  17
Immune system disorders   
Hypersensitivity * 1  16/279 (5.73%)  17
Infections and infestations   
Upper respiratory tract infection * 1  118/279 (42.29%)  205
Bronchitis * 1  89/279 (31.90%)  152
Sinusitis * 1  64/279 (22.94%)  140
Acute sinusitis * 1  48/279 (17.20%)  80
Oral candidiasis * 1  40/279 (14.34%)  71
Influenza * 1  38/279 (13.62%)  48
Pneumonia * 1  37/279 (13.26%)  49
Nasopharyngitis * 1  28/279 (10.04%)  42
Urinary tract infection * 1  23/279 (8.24%)  41
Lower respiratory tract infection * 1  19/279 (6.81%)  26
Musculoskeletal and connective tissue disorders   
Back pain * 1  18/279 (6.45%)  23
Nervous system disorders   
Headache * 1  22/279 (7.89%)  28
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  234/279 (83.87%)  1258
Cough * 1  54/279 (19.35%)  78
Wheezing * 1  40/279 (14.34%)  63
Dyspnoea * 1  24/279 (8.60%)  29
Throat irritation * 1  15/279 (5.38%)  17
Rhinitis allergic * 1  15/279 (5.38%)  18
Vascular disorders   
Hypertension * 1  16/279 (5.73%)  19
1
Term from vocabulary, MedDRA (17.1)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: G Mark Grubb
Organization: Boston Scientific Corp.
Phone: (412) 716-0717
EMail: grubbm@bsci.com
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01350336    
Other Study ID Numbers: 10-02
First Submitted: April 15, 2011
First Posted: May 9, 2011
Results First Submitted: January 25, 2021
Results First Posted: March 5, 2021
Last Update Posted: March 5, 2021