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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.
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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alair Treatment | Experimental | 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. |
|
| Control | No Intervention | Control group subjects from PREDECESSOR STUDY (NCT00214526). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchial Thermoplasty with the Alair System | Device | Treatment of airways with the Alair System (Bronchial Thermoplasty) in the PREDECESSOR STUDY (NCT00214526). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Any Respiratory Adverse Event | 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. | 12 Month periods out to 5 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Health Care Usage | 12 Month periods out to 5 years | |
| Number of Respiratory Adverse Events | Number of respiratory adverse events per subject | 12 Month periods out to 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Narinder S Shargill, PhD | Asthmatx, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | CEP 90035 074 | Brazil | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21314924 | Result | Thomson NC, Rubin AS, Niven RM, Corris PA, Siersted HC, Olivenstein R, Pavord ID, McCormack D, Laviolette M, Shargill NS, Cox G; AIR Trial Study Group. Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial. BMC Pulm Med. 2011 Feb 11;11:8. doi: 10.1186/1471-2466-11-8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alair | Alair-treated subjects from AIR PREDECESSOR STUDY (NCT00214526). |
| FG001 | Control | Control subjects from AIR PREDECESSOR STUDY (NCT00214526). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 1 |
| |||||||||||||
| Year 2 |
| |||||||||||||
| Year 3 |
| |||||||||||||
| Year 4 |
| |||||||||||||
| Year 5 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alair Treatment | Alair treated subjects from PREDECESSOR STUDY (NCT00214526). Bronchial Thermoplasty with the Alair System: Treatment of airways with the Alair System in the PREDECESSOR STUDY. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Any Respiratory Adverse Event | 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. | Posted | Count of Participants | Participants | 12 Month periods out to 5 years |
|
Year 1 Post-Treatment out to 5 years for Alair participants, Year 1 Post-Treatment out to 3 years for Control participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alair - Year 1 | Alair treated subjects from PREDECESSOR STUDY (NCT00214526). | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left Leg Fracture | Injury, poisoning and procedural complications | Systematic Assessment | Non-respiratory |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment | Non-Respiratory |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| G Mark Grubb, RN, CCRA | Boston Scientific Corp. | +1 (412) 716-0717 | grubbm@bsci.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000074060 | Bronchial Thermoplasty |
| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
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| Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | 12 Month periods out to 5 years |
| St. Joseph's Healthcare |
| Hamilton |
| Ontario |
| L8N 4A6 |
| Canada |
| Hopital Laval, Laval University | Sainte-Foy | Quebec | G1V 4GS | Canada |
| Gartnavel General Hospital, Univ. Glasgow | Glasgow | Scotland | G12 0YN | United Kingdom |
| Northwest Lung Research Center, Univ. Manchester | Manchester | M23 9LT | United Kingdom |
| NOT COMPLETED |
|
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| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
Control group subjects from PREDECESSOR STUDY (NCT00214526).
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| Inhaled Corticosteroid Dose | Dose of Beclomethasone. All other inhaled corticosteroid doses were converted to their equivalent doses of Beclomethasone. | Mean | Standard Deviation | mcg (micrograms) |
|
| Long-acting Beta Agonists (LABA) Dose | Dose of Salmeterol. All other LABA doses were converted to their equivalent doses of Salmeterol. | Mean | Standard Deviation | mcg (micrograms) |
|
| Methacholine PC20 | PC20 is the provocative concentration required to achieve a 20% fall in forced expired volume in one second (FEV1). | Geometric Mean | Full Range | mg/ml |
|
| Asthma Control Questionnaire (ACQ) Overall Score | The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% predicted and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). | Mean | Standard Deviation | Scores on a scale |
|
| Asthma Quality of Life Questionnaire (AQLQ) Score | There are 32 questions in the 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. | Mean | Standard Deviation | Scores on a scale |
|
| Alair Year 2 |
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 |
| OG002 | Alair Year 3 | 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 |
| OG003 | Alair Year 4 | 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 |
| OG004 | Alair Year 5 | 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 |
| OG005 | Control Year 1 | Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 1. |
| OG006 | Control Year 2 | Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 2. |
| OG007 | Control Year 3 | Control group subjects from PREDECESSOR STUDY (NCT00214526) Year 3. |
|
|
| Other Pre-specified | Health Care Usage | Posted | Mean | Standard Deviation | Number events per subject | 12 Month periods out to 5 years |
|
|
|
| Other Pre-specified | Number of Respiratory Adverse Events | Number of respiratory adverse events per subject | Posted | Mean | Standard Deviation | Number events per subject | 12 Month periods out to 5 years |
|
|
|
| Other Pre-specified | Forced Expiratory Volume in 1 Second (FEV1) - % Predicted | Posted | Mean | Standard Deviation | percentage predicted | 12 Month periods out to 5 years |
|
|
|
| 45 |
| 4 |
| 45 |
| 42 |
| 45 |
| EG001 | Alair - Year 2 | Alair treated subjects from PREDECESSOR STUDY (NCT00214526). | 0 | 45 | 4 | 45 | 23 | 45 |
| EG002 | Alair - Year 3 | Alair treated subjects from PREDECESSOR STUDY (NCT00214526). | 0 | 43 | 3 | 43 | 23 | 43 |
| EG003 | Alair - Year 4 | Alair treated subjects from PREDECESSOR STUDY (NCT00214526). | 0 | 43 | 3 | 43 | 22 | 43 |
| EG004 | Alair - Year 5 | Alair treated subjects from PREDECESSOR STUDY (NCT00214526). | 0 | 42 | 3 | 42 | 22 | 42 |
| EG005 | Control - Year 1 | Control treated subjects from PREDECESSOR STUDY (NCT00214526). | 0 | 24 | 2 | 24 | 19 | 24 |
| EG006 | Control - Year 2 | Control treated subjects from PREDECESSOR STUDY (NCT00214526). | 0 | 23 | 0 | 23 | 12 | 23 |
| EG007 | Control - Year 3 | Control treated subjects from PREDECESSOR STUDY (NCT00214526). | 0 | 21 | 1 | 21 | 11 | 21 |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Lower Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Knee surgery | Surgical and medical procedures | Systematic Assessment | Non-respiratory |
|
| Nasosinusal polyps | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Lung infection pseudomonal | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment | Non-respiratory |
|
| Inguinal hernia | Gastrointestinal disorders | Systematic Assessment | Non-respiratory |
|
| Umbilical hernia | Gastrointestinal disorders | Systematic Assessment | Non-respiratory |
|
| Tubal obstruction | Reproductive system and breast disorders | Systematic Assessment | Non-respiratory |
|
| Pyrexia | General disorders | Systematic Assessment | Non-respiratory |
|
| Sepsis | Infections and infestations | Systematic Assessment | Non-respiratory |
|
| Headache | Nervous system disorders | Systematic Assessment | Non-respiratory |
|
| Chest discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Calculus urinary | Renal and urinary disorders | Systematic Assessment | Non-respiratory |
|
| Laparotomy | Surgical and medical procedures | Systematic Assessment | Non-respiratory |
|
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Non-Respiratory |
|
| Ear infection | Infections and infestations | Systematic Assessment | Non-Respiratory |
|
| Influenza | Infections and infestations | Systematic Assessment | Non-Respiratory |
|
| Sinusitis | Infections and infestations | Systematic Assessment | Non-Respiratory |
|
| Tonsillitis | Infections and infestations | Systematic Assessment | Non-Respiratory |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment | Non-Respiratory |
|
| Headache | Nervous system disorders | Systematic Assessment | Non-Respiratory |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Chest discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Lower respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Nocturnal dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Tracheobronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D055011 |
| Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| Emergency Room (ER) Visits for Respiratory Symptoms |
|
| Unscheduled Physician Office Visits for Respiratory Symptoms |
|
| Post-Bronchodilator Off-LABA |
|