AIRx: AIR Extension Study - Long-Term Safety of Alair Treated Subjects
Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00448812
Collaborator
(none)
69
5
2
61
13.8
0.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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".
Study Design
Study Type:
Interventional
Actual Enrollment
:
69 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Extension Study for the Multicenter Randomized Clinical Trial of the Alair® System for the Bronchial Thermoplasty Treatment of Asthma (NCT00214526)
Study Start Date
:
Mar 1, 2005
Actual Primary Completion Date
:
Dec 1, 2009
Actual Study Completion Date
:
Apr 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Alair Treatment Subjects from PREDECESSOR STUDY (NCT00214526) treated with conventional therapy with ICS+LABA (inhaled corticosteroid + long-acting beta-agonist) plus Bronchial Thermoplasty with the Alair System. |
Device: Bronchial Thermoplasty with the Alair System
Treatment of airways with the Alair System (Bronchial Thermoplasty) in the PREDECESSOR STUDY (NCT00214526).
|
| No Intervention: Control Control group subjects from PREDECESSOR STUDY (NCT00214526). |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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).
-
Subject who is able to read, understand, and provide written Informed Consent.
-
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:
-
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.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre | RS | Brazil | CEP 90035 074 |
| 2 | St. Joseph's Healthcare | Hamilton | Ontario | Canada | L8N 4A6 |
| 3 | Hopital Laval, Laval University | Sainte-Foy | Quebec | Canada | G1V 4GS |
| 4 | Gartnavel General Hospital, Univ. Glasgow | Glasgow | Scotland | United Kingdom | G12 0YN |
| 5 | Northwest Lung Research Center, Univ. Manchester | Manchester | United Kingdom | M23 9LT |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Study Director: Narinder S Shargill, PhD, Asthmatx, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00448812
Other Study ID Numbers:
- 05-01
First Posted:
Mar 19, 2007
Last Update Posted:
Feb 17, 2021
Last Verified:
Jan 1, 2021
Keywords provided by Boston Scientific Corporation
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Alair | Control |
|---|---|---|
| Arm/Group Description | Alair-treated subjects from AIR PREDECESSOR STUDY (NCT00214526). | Control subjects from AIR PREDECESSOR STUDY (NCT00214526). |
| Period Title: Year 1 | ||
| STARTED | 45 | 24 |
| COMPLETED | 45 | 24 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Year 1 | ||
| STARTED | 45 | 24 |
| COMPLETED | 41 | 23 |
| NOT COMPLETED | 4 | 1 |
| Period Title: Year 1 | ||
| STARTED | 45 | 24 |
| COMPLETED | 41 | 21 |
| NOT COMPLETED | 4 | 3 |
| Period Title: Year 1 | ||
| STARTED | 43 | 0 |
| COMPLETED | 43 | 0 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Year 1 | ||
| STARTED | 43 | 0 |
| COMPLETED | 42 | 0 |
| NOT COMPLETED | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Alair Treatment | Control | Total |
|---|---|---|---|
| Arm/Group Description | Alair treated subjects from PREDECESSOR STUDY (NCT00214526). Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY. | Control group subjects from PREDECESSOR STUDY (NCT00214526). | Total of all reporting groups |
| Overall Participants | 45 | 24 | 69 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
40
(11.21)
|
40.88
(12.13)
|
40.30
(11.46)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
26
57.8%
|
15
62.5%
|
41
59.4%
|
| Male |
19
42.2%
|
9
37.5%
|
28
40.6%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| White |
41
91.1%
|
22
91.7%
|
63
91.3%
|
| Black |
3
6.7%
|
2
8.3%
|
5
7.2%
|
| Hispanic |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
2.2%
|
0
0%
|
1
1.4%
|
| Height (cm) (cm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [cm] |
166.17
(9.64)
|
164.83
(7.72)
|
165.70
(8.99)
|
| Weight (kg) (kg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg] |
76.37
(23.31)
|
77.71
(16.95)
|
76.84
(21.20)
|
| Inhaled Corticosteroid Dose (mcg (micrograms)) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mcg (micrograms)] |
1291.11
(862.10)
|
1135.42
(1030.46)
|
1236.96
(919.58)
|
| Long-acting Beta Agonists (LABA) Dose (mcg (micrograms)) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mcg (micrograms)] |
108.89
(33.78)
|
100.00
(14.74)
|
105.80
(28.81)
|
| Methacholine PC20 (mg/ml) [Geometric Mean (Full Range) ] | |||
| Geometric Mean (Full Range) [mg/ml] |
0.25
|
0.28
|
0.26
|
| Asthma Control Questionnaire (ACQ) Overall Score (Scores on a scale) [Mean (Standard Deviation) ] | |||
| LABA Stable |
1.39
(0.68)
|
1.29
(0.7)
|
1.36
(0.89)
|
| LABA Withdrawal |
2.50
(0.97)
|
2.08
(0.90)
|
2.35
(0.96)
|
| Asthma Quality of Life Questionnaire (AQLQ) Score (Scores on a scale) [Mean (Standard Deviation) ] | |||
| LABA Stable |
5.65
(0.99)
|
5.62
(0.92)
|
5.64
(0.96)
|
| LABA Withdrawal |
4.88
(1.30)
|
4.84
(1.40)
|
4.86
(1.33)
|
Outcome Measures
| Title | Percentage of Subjects With Any Respiratory Adverse Event |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Alair Year 1 | Alair Year 2 | Alair Year 3 | Alair Year 4 | Alair Year 5 | Control Year 1 | Control Year 2 | Control Year 3 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 1. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 2. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 3. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 4. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 5. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 1. | Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 2. | Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 3. |
| Measure Participants | 45 | 45 | 43 | 43 | 42 | 24 | 24 | 21 |
| Count of Participants [Participants] |
38
84.4%
|
24
100%
|
24
34.8%
|
23
NaN
|
22
NaN
|
18
NaN
|
13
NaN
|
12
NaN
|
| Title | Health Care Usage |
|---|---|
| Description | |
| Time Frame | 12 Month periods out to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Alair Year 1 | Alair Year 2 | Alair Year 3 | Alair Year 4 | Alair Year 5 | Control Year 1 | Control Year 2 | Control Year 3 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 1. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 2. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 3. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 4. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 5. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 1. | Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 2. | Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 3. |
| Measure Participants | 45 | 45 | 43 | 43 | 42 | 24 | 24 | 21 |
| Hospitalizations for Respiratory Symptoms |
0.07
(0.25)
|
0.07
(0.25)
|
0.07
(0.46)
|
0.02
(0.15)
|
0.02
(0.15)
|
0.00
(0.00)
|
0.00
(0.00)
|
0.05
(0.22)
|
| Emergency Room (ER) Visits for Respiratory Symptoms |
0.04
(0.21)
|
0.07
(0.25)
|
0.07
(0.34)
|
0.14
(0.47)
|
0.05
(0.22)
|
0.00
(0.00)
|
0.13
(0.34)
|
0.14
(0.85)
|
| Unscheduled Physician Office Visits for Respiratory Symptoms |
0.42
(0.72)
|
0.18
(0.44)
|
0.44
(0.70)
|
0.70
(1.21)
|
0.48
(0.94)
|
0.42
(0.72)
|
0.25
(0.74)
|
0.29
(0.64)
|
| Title | Number of Respiratory Adverse Events |
|---|---|
| Description | Number of respiratory adverse events per subject |
| Time Frame | 12 Month periods out to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Alair Year 1 | Alair Year 2 | Alair Year 3 | Alair Year 4 | Alair Year 5 | Control Year 1 | Control Year 2 | Control Year 3 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 1. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 2. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 3. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 4. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 5. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 1. | Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 2. | Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 3. |
| Measure Participants | 45 | 45 | 43 | 43 | 42 | 24 | 24 | 21 |
| Mean (Standard Deviation) [Number events per subject] |
4.5
(4.2)
|
1.2
(1.6)
|
1.3
(1.9)
|
1.2
(1.6)
|
1.1
(2.2)
|
3.1
(3.7)
|
1.2
(1.1)
|
1.3
(1.6)
|
| Title | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted |
|---|---|
| Description | |
| Time Frame | 12 Month periods out to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Alair Year 1 | Alair Year 2 | Alair Year 3 | Alair Year 4 | Alair Year 5 | Control Year 1 | Control Year 2 | Control Year 3 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 1. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 2. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 3. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 4. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Alair treated subjects from PREDECESSOR STUDY (NCT00214526), Year 5. Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY | Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 1. | Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 2. | Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 3. |
| Measure Participants | 40 | 37 | 35 | 36 | 35 | 19 | 23 | 21 |
| Pre-Bronchodilator Off-LABA |
76.0
(14.0)
|
73.5
(15.0)
|
73.9
(12.6)
|
74.3
(15.0)
|
70.6
(14.6)
|
71.6
(11.6)
|
74.8
(10.6)
|
70.1
(16.9)
|
| Post-Bronchodilator Off-LABA |
84.5
(13.3)
|
85.0
(13.1)
|
85.1
(11.6)
|
84.6
(14.2)
|
83.5
(13.5)
|
82.2
(8.5)
|
86.3
(9.7)
|
80.7
(19.8)
|
Adverse Events
| Time Frame | Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants. | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||
| Arm/Group Title | Alair - Year 1 | Alair - Year 2 | Alair - Year 3 | Alair - Year 4 | Alair - Year 5 | Control - Year 1 | Control - Year 2 | Control - Year 3 | ||||||||
| Arm/Group Description | Alair treated subjects from PREDECESSOR STUDY (NCT00214526). | Alair treated subjects from PREDECESSOR STUDY (NCT00214526). | Alair treated subjects from PREDECESSOR STUDY (NCT00214526). | Alair treated subjects from PREDECESSOR STUDY (NCT00214526). | Alair treated subjects from PREDECESSOR STUDY (NCT00214526). | Control treated subjects from PREDECESSOR STUDY (NCT00214526). | Control treated subjects from PREDECESSOR STUDY (NCT00214526). | Control treated subjects from PREDECESSOR STUDY (NCT00214526). | ||||||||
All Cause Mortality |
||||||||||||||||
| Alair - Year 1 | Alair - Year 2 | Alair - Year 3 | Alair - Year 4 | Alair - Year 5 | Control - Year 1 | Control - Year 2 | Control - Year 3 | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/45 (0%) | 0/45 (0%) | 0/43 (0%) | 0/43 (0%) | 0/42 (0%) | 0/24 (0%) | 0/23 (0%) | 0/21 (0%) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Alair - Year 1 | Alair - Year 2 | Alair - Year 3 | Alair - Year 4 | Alair - Year 5 | Control - Year 1 | Control - Year 2 | Control - Year 3 | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/45 (8.9%) | 4/45 (8.9%) | 3/43 (7%) | 3/43 (7%) | 3/42 (7.1%) | 2/24 (8.3%) | 0/23 (0%) | 1/21 (4.8%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Diverticulitis | 0/45 (0%) | 0 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 1/42 (2.4%) | 1 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Inguinal hernia | 0/45 (0%) | 0 | 0/45 (0%) | 0 | 1/43 (2.3%) | 1 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Umbilical hernia | 0/45 (0%) | 0 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 1/43 (2.3%) | 1 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| General disorders | ||||||||||||||||
| Pyrexia | 1/45 (2.2%) | 1 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Infections and infestations | ||||||||||||||||
| Sepsis | 1/45 (2.2%) | 2 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||
| Left Leg Fracture | 0/45 (0%) | 0 | 1/45 (2.2%) | 1 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||
| Headache | 1/45 (2.2%) | 2 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||||
| Calculus urinary | 1/45 (2.2%) | 2 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||||||
| Tubal obstruction | 0/45 (0%) | 0 | 0/45 (0%) | 0 | 1/43 (2.3%) | 1 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Asthma | 0/45 (0%) | 0 | 2/45 (4.4%) | 2 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Lower Respiratory Tract Infection | 1/45 (2.2%) | 1 | 1/45 (2.2%) | 1 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 1/42 (2.4%) | 1 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Pneumonia | 0/45 (0%) | 0 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 1/42 (2.4%) | 1 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Nasosinusal polyps | 0/45 (0%) | 0 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 1/43 (2.3%) | 1 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Lung infection pseudomonal | 1/45 (2.2%) | 2 | 0/45 (0%) | 0 | 1/43 (2.3%) | 1 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Chest discomfort | 1/45 (2.2%) | 2 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 1/24 (4.2%) | 2 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Cough | 1/45 (2.2%) | 1 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Dyspnoea | 2/45 (4.4%) | 3 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 1/24 (4.2%) | 2 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Respiratory tract infection | 1/45 (2.2%) | 1 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Wheezing | 2/45 (4.4%) | 2 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 1/24 (4.2%) | 1 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Surgical and medical procedures | ||||||||||||||||
| Knee surgery | 0/45 (0%) | 0 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 1/43 (2.3%) | 1 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Laparotomy | 0/45 (0%) | 0 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 1/21 (4.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Alair - Year 1 | Alair - Year 2 | Alair - Year 3 | Alair - Year 4 | Alair - Year 5 | Control - Year 1 | Control - Year 2 | Control - Year 3 | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 42/45 (93.3%) | 23/45 (51.1%) | 23/43 (53.5%) | 22/43 (51.2%) | 22/42 (52.4%) | 19/24 (79.2%) | 12/23 (52.2%) | 11/21 (52.4%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Gastrooesophageal reflux disease | 2/45 (4.4%) | 2 | 0/45 (0%) | 0 | 2/43 (4.7%) | 2 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Nausea | 4/45 (8.9%) | 4 | 0/45 (0%) | 0 | 1/43 (2.3%) | 1 | 1/43 (2.3%) | 1 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Infections and infestations | ||||||||||||||||
| Ear infection | 3/45 (6.7%) | 3 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 1/43 (2.3%) | 1 | 0/42 (0%) | 0 | 1/24 (4.2%) | 1 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Influenza | 3/45 (6.7%) | 3 | 0/45 (0%) | 0 | 1/43 (2.3%) | 1 | 1/43 (2.3%) | 1 | 3/42 (7.1%) | 3 | 1/24 (4.2%) | 1 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Sinusitis | 2/45 (4.4%) | 3 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 2/24 (8.3%) | 2 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Tonsillitis | 3/45 (6.7%) | 3 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 1/43 (2.3%) | 1 | 1/42 (2.4%) | 1 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Arthralgia | 2/45 (4.4%) | 3 | 1/45 (2.2%) | 1 | 0/43 (0%) | 0 | 2/43 (4.7%) | 2 | 0/42 (0%) | 0 | 1/24 (4.2%) | 1 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||
| Headache | 13/45 (28.9%) | 36 | 1/45 (2.2%) | 1 | 1/43 (2.3%) | 1 | 2/43 (4.7%) | 2 | 1/42 (2.4%) | 2 | 4/24 (16.7%) | 4 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Asthma | 0/45 (0%) | 0 | 4/45 (8.9%) | 5 | 7/43 (16.3%) | 8 | 7/43 (16.3%) | 8 | 6/42 (14.3%) | 8 | 0/24 (0%) | 0 | 2/23 (8.7%) | 2 | 1/21 (4.8%) | 4 |
| Chest discomfort | 7/45 (15.6%) | 9 | 2/45 (4.4%) | 2 | 3/43 (7%) | 4 | 1/43 (2.3%) | 1 | 2/42 (4.8%) | 2 | 3/24 (12.5%) | 5 | 1/23 (4.3%) | 2 | 1/21 (4.8%) | 1 |
| Cough | 17/45 (37.8%) | 29 | 4/45 (8.9%) | 5 | 2/43 (4.7%) | 2 | 3/43 (7%) | 4 | 2/42 (4.8%) | 6 | 8/24 (33.3%) | 9 | 0/23 (0%) | 0 | 3/21 (14.3%) | 3 |
| Dyspnoea | 20/45 (44.4%) | 40 | 4/45 (8.9%) | 4 | 4/43 (9.3%) | 4 | 4/43 (9.3%) | 5 | 4/42 (9.5%) | 7 | 12/24 (50%) | 22 | 2/23 (8.7%) | 2 | 3/21 (14.3%) | 3 |
| Lower respiratory tract infection | 0/45 (0%) | 0 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 2/43 (4.7%) | 4 | 2/42 (4.8%) | 3 | 0/24 (0%) | 0 | 3/23 (13%) | 3 | 1/21 (4.8%) | 1 |
| Nasal congestion | 13/45 (28.9%) | 21 | 2/45 (4.4%) | 2 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 1/42 (2.4%) | 2 | 5/24 (20.8%) | 6 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Nasopharyngitis | 6/45 (13.3%) | 7 | 1/45 (2.2%) | 1 | 0/43 (0%) | 0 | 1/43 (2.3%) | 1 | 1/42 (2.4%) | 1 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Nocturnal dyspnoea | 6/45 (13.3%) | 7 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 2/24 (8.3%) | 3 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Pharyngolaryngeal pain | 5/45 (11.1%) | 7 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 4/24 (16.7%) | 4 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Productive cough | 9/45 (20%) | 14 | 2/45 (4.4%) | 2 | 2/43 (4.7%) | 2 | 0/43 (0%) | 0 | 1/42 (2.4%) | 1 | 6/24 (25%) | 6 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Respiratory tract congestion | 4/45 (8.9%) | 4 | 0/45 (0%) | 0 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 2/24 (8.3%) | 2 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Respiratory tract infection | 4/45 (8.9%) | 5 | 3/45 (6.7%) | 3 | 5/43 (11.6%) | 6 | 3/43 (7%) | 6 | 2/42 (4.8%) | 3 | 5/24 (20.8%) | 6 | 2/23 (8.7%) | 4 | 1/21 (4.8%) | 1 |
| Rhinitis | 1/45 (2.2%) | 1 | 0/45 (0%) | 0 | 1/43 (2.3%) | 1 | 0/43 (0%) | 0 | 2/42 (4.8%) | 2 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Sinusitis | 0/45 (0%) | 0 | 1/45 (2.2%) | 1 | 2/43 (4.7%) | 3 | 2/43 (4.7%) | 2 | 2/42 (4.8%) | 2 | 0/24 (0%) | 0 | 1/23 (4.3%) | 1 | 0/21 (0%) | 0 |
| Sputum discoloured | 4/45 (8.9%) | 5 | 3/45 (6.7%) | 4 | 0/43 (0%) | 0 | 0/43 (0%) | 0 | 0/42 (0%) | 0 | 0/24 (0%) | 0 | 0/23 (0%) | 0 | 0/21 (0%) | 0 |
| Tracheobronchitis | 0/45 (0%) | 0 | 0/45 (0%) | 0 | 1/43 (2.3%) | 1 | 1/43 (2.3%) | 1 | 1/42 (2.4%) | 1 | 1/24 (4.2%) | 1 | 0/23 (0%) | 0 | 2/21 (9.5%) | 3 |
| Upper respiratory tract infection | 10/45 (22.2%) | 15 | 11/45 (24.4%) | 17 | 8/43 (18.6%) | 13 | 8/43 (18.6%) | 13 | 4/42 (9.5%) | 5 | 2/24 (8.3%) | 3 | 3/23 (13%) | 5 | 4/21 (19%) | 7 |
| Wheezing | 14/45 (31.1%) | 19 | 2/45 (4.4%) | 3 | 3/43 (7%) | 5 | 3/43 (7%) | 4 | 2/42 (4.8%) | 2 | 4/24 (16.7%) | 6 | 1/23 (4.3%) | 1 | 1/21 (4.8%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | G Mark Grubb, RN, CCRA |
|---|---|
| Organization | Boston Scientific Corp. |
| Phone | +1 (412) 716-0717 |
| grubbm@bsci.com |
Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00448812
Other Study ID Numbers:
- 05-01
First Posted:
Mar 19, 2007
Last Update Posted:
Feb 17, 2021
Last Verified:
Jan 1, 2021