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The primary purpose of this study is to gather additional safety data for the subjects treated with the Alair System (hereinafter, "Alair-Treated Subjects") who previously completed the one-year study entitled: "Multicenter Randomized Clinical Trial of Bronchial Thermoplasty with the Alair System for the Treatment of Severe Asthma" (Protocol #0903-27) sponsored by Asthmatx, Inc. Subjects who elect to participate in this safety study will be followed for an additional four (4) year period beyond the PREDECESSOR STUDY'S one-year endpoint (clinicaltrials.gov number NCT00214539).
This will be a multicenter study conducted only at the clinical sites that participated in the PREDECESSOR STUDY (NCT00214539).
Enrollment will be limited to only those subjects who were treated with the Alair System in the PREDECESSOR STUDY.
Written, informed consent will be obtained from all subjects prior to performing any study procedures.
The present study will extend the follow-up evaluation of Alair-Treated Subjects from the PREDECESSOR STUDY to 5 years post-treatment with the Alair System. These evaluations will consist of four study visits corresponding to the two-year, three-year, four-year and five-year time points following completion of Alair treatments in the PREDECESSOR STUDY. For consistency with the PREDECESSOR STUDY, ideally the subject's drug therapy should continue to be consistent with GINA (Global Initiative for Asthma) Guidelines for the severity of the subject's asthma. Any changes in maintenance levels of asthma medications will be documented.
The goal of this follow-on study is to enroll all Alair-Treated Subjects who completed the PREDECESSOR STUDY. Inclusion of subjects from the treatment arm will allow for better assessment of the long-term safety of the Alair procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alair Treatment | Alair Treated subjects from PREDECESSOR STUDY (NCT00214539). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchial thermoplasty with the Alair System | Device | Treatment of airways with the Alair System in PREDECESSOR STUDY (NCT00214539). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments | The respiratory-related adverse event profile for the Alair group was analyzed on an annual basis in order to highlight trends in adverse occurrence. | 2-year, 3-year, 4-year and 5-year follow up post procedure |
| Respiratory Adverse Events | Pull down menu does not have a rate unit. Numbers reported represents Rate of Respiratory Adverse (number of Events/number of Subject/year). | 2-year, 3-year, 4-year and 5-year follow up post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalizations for Respiratory Symptoms | Pull down menu does not have a rate unit. Rate of Hospitalizations for Respiratory Symptoms (number of Events/number of Subject/year) | 2-year, 3-year, 4-year and 5-year follow up post procedure |
| Emergency Room Visits for Respiratory Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with severe asthma, previously treated with the Alair System in the PREDECESSOR STUDY (NCT00214539).
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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 | 90570-080 | Brazil | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17901415 | Background | Pavord ID, Cox G, Thomson NC, Rubin AS, Corris PA, Niven RM, Chung KF, Laviolette M; RISA Trial Study Group. Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. Am J Respir Crit Care Med. 2007 Dec 15;176(12):1185-91. doi: 10.1164/rccm.200704-571OC. Epub 2007 Sep 27. | |
| 21314924 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alair Group | A total of 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) provided consent and participated in the RISA Extension Study evaluating the longer-term safety of the Alair treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alair Group | Baseline Demographics are based on data collected at the time of entry into the PREDECESSOR STUDY (NCT00214539). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Respiratory Adverse Events (AEs) in Annual Increments | The respiratory-related adverse event profile for the Alair group was analyzed on an annual basis in order to highlight trends in adverse occurrence. | A total of 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) provided consent and participated in the RISA Extension Study evaluating the longer-term safety of the Alair treatment. All 14 subjects completed their Year 3 visit and 12 subjects have completed their Year 4 and 5 visits. | Posted | Number | percentage subjects with respiratory AEs | 2-year, 3-year, 4-year and 5-year follow up post procedure |
|
Year 2 post procedure out to 5 years (total of 4 years). 14 Alair group subjects from the PREDECESSOR STUDY (NCT00214539) participated in the RISA Extension Study.
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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 | Year 2 | Conventional therapy with high dose ICS+LABA±OCS (≤30mg/day) plus Alair Treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | Non-Respiratory |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | Respiratory |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| G Mark Grubb, RN, CCRA | Boston Scientific Corp. | (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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Pull down menu does not have a rate unit. Rate of Emergency Room Visits for Respiratory Symptoms (number of Events/number of Subjects/year) |
| 2-year, 3-year, 4-year and 5-year follow up post procedure |
| St. Joseph's Healthcare |
| Hamilton |
| Ontario |
| L8N 4A6 |
| Canada |
| Hospital Laval, University of Laval | Sainte-Foy | Quebec | G1V 4G5 | Canada |
| Gartnavel General Hospital, Univ. Glasgow | Glasgow | United Kingdom |
| Glenfield General Hospital, Univ. Leicester | Leicester | LE3 9QP | United Kingdom |
| National Heart and Lung Institute, Imperial College | London | SW3 6NP | United Kingdom |
| Northwest Lung Research Center, University of Manchester | Manchester | M23 9LT | United Kingdom |
| William Leech Center, Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| 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. |
| 24125149 | Result | Pavord ID, Thomson NC, Niven RM, Corris PA, Chung KF, Cox G, Armstrong B, Shargill NS, Laviolette M; Research in Severe Asthma Trial Study Group. Safety of bronchial thermoplasty in patients with severe refractory asthma. Ann Allergy Asthma Immunol. 2013 Nov;111(5):402-7. doi: 10.1016/j.anai.2013.05.002. Epub 2013 Jun 13. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| amPEF (Peak Expiratory Flow) | Mean | Standard Deviation | L/min (liters per minute) |
|
| Pre-Bronchodilator FEV1 (Forced Expiratory Volume in 1 second) | Mean | Standard Deviation | % predicted |
|
| Post-Bronchodilator FEV1 | Mean | Standard Deviation | % predicted |
|
| ICS Dose (Inhaled Corticosteroid dose) | Mean | Standard Deviation | µg/day (microgram/day) |
|
| LABA Dose (Long-acting Beta Agonists) | Mean | Standard Deviation | µg/day (microgram/day) |
|
| OCS Dose (Oral corticosteroids) | Mean | Standard Deviation | mg/day (milligrams/day) |
|
| Rescue Medication Use | Mean | Standard Deviation | Puffs/7 days |
|
| Asthma Control Questionnaire (ACQ) 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 |
|
| Symptom-Free Days | Symptom-Free Days were defined as days when Subject reported no cough, wheeze, breathlessness, or sputum during the daytime, and no wheeze, cough, or awakenings due to asthma symptoms during nighttime. | Mean | Standard Deviation | percentage of days |
|
| Total Symptom Score | Total Symptom Score comprises the sum of these six asthma symptom measurements: wheeze during the night, cough during the night, wheeze during the day, cough during the day, breathlessness during the day, and sputum production during the day. Each of these symptoms is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18; the minimum possible score is 0. A lower Total Symptom score represents better asthma control. | Mean | Standard Deviation | scores on a scale |
|
| Unscheduled Physician Office Visits | Number of Events (number of Subjects) = 8 (6) | Number | Number of events |
|
| Emergency Room Visits | Number of Events (number of Subjects) = 5 (4) | Number | Number of events |
|
| Hospitalizations | Number of Events (number of Subjects) = 10 (6) | Number | Number of events |
|
|
|
| Primary | Respiratory Adverse Events | Pull down menu does not have a rate unit. Numbers reported represents Rate of Respiratory Adverse (number of Events/number of Subject/year). | Subject attrition at years 4 & 5 | Posted | Number | Number of events/number of subject/Year | 2-year, 3-year, 4-year and 5-year follow up post procedure |
|
|
|
| Secondary | Hospitalizations for Respiratory Symptoms | Pull down menu does not have a rate unit. Rate of Hospitalizations for Respiratory Symptoms (number of Events/number of Subject/year) | Subject attrition at years 4 & 5 | Posted | Number | Number of events/number of subject/Year | 2-year, 3-year, 4-year and 5-year follow up post procedure |
|
|
|
| Secondary | Emergency Room Visits for Respiratory Symptoms | Pull down menu does not have a rate unit. Rate of Emergency Room Visits for Respiratory Symptoms (number of Events/number of Subjects/year) | Subject attrition at years 4 & 5 | Posted | Number | Number of events/number of subject/Year | 2-year, 3-year, 4-year and 5-year follow up post procedure |
|
|
|
| 5 |
| 14 |
| 11 |
| 14 |
| EG001 | Year 3 | Conventional therapy with high dose ICS+LABA±OCS (≤30mg/day) plus Alair Treatment | 4 | 14 | 12 | 14 |
| EG002 | Year 4 | Conventional therapy with high dose ICS+LABA±OCS (≤30mg/day) plus Alair Treatment | 3 | 12 | 11 | 12 |
| EG003 | Year 5 | Conventional therapy with high dose ICS+LABA±OCS (≤30mg/day) plus Alair Treatment | 3 | 12 | 12 | 12 |
| Vomiting | Gastrointestinal disorders | Non-Respiratory |
|
| Pyrexia | General disorders | Non-Respiratory |
|
| Tibia fracture | Injury, poisoning and procedural complications | Non-Respiratory |
|
| Sudden Death | Injury, poisoning and procedural complications | Non-Respiratory |
|
| Dehydration | Metabolism and nutrition disorders | Non-Respiratory |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-Respiratory |
|
| Headache | Nervous system disorders | Non-Respiratory |
|
| Renal colic | Renal and urinary disorders | Non-Respiratory |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Chest pain | Respiratory, thoracic and mediastinal disorders | Non-Respiratory |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Dyspnoea exacerbated | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Lower respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Nocturnal dyspnoea | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Asthma exacerbation prophylaxis | Surgical and medical procedures | Respiratory |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Chest discomfort | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Chest pain | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Chronic obstructive airways disease exacerbated | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Lower respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Lower respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Respiratory |
|
| Anaemia | Blood and lymphatic system disorders | Non-Respiratory |
|
| Sinus tachycardia | Cardiac disorders | Non-Respiratory |
|
| Tachycardia | Cardiac disorders | Non-Respiratory |
|
| Abdominal pain | Gastrointestinal disorders | Non-Respiratory |
|
| Colonic polyp | Gastrointestinal disorders | Non-Respiratory |
|
| Diarrhoea | Gastrointestinal disorders | Non-Respiratory |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-Respiratory |
|
| Nausea | Gastrointestinal disorders | Non-Respiratory |
|
| Vomiting | Gastrointestinal disorders | Non-Respiratory |
|
| Mass | General disorders | Non-Respiratory |
|
| Venipuncture site thrombosis | General disorders | Non-Respiratory |
|
| Candidiasis | Infections and infestations | Non-Respiratory |
|
| Ear infection | Infections and infestations | Non-Respiratory |
|
| Gastritis viral | Infections and infestations | Non-Respiratory |
|
| Gastroenteritis bacterial | Infections and infestations | Non-Respiratory |
|
| Whiplash injury | Injury, poisoning and procedural complications | Non-Respiratory |
|
| Diabetes mellitus non-insulin-dependent | Metabolism and nutrition disorders | Non-Respiratory |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | Non-Respiratory |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-Respiratory |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-Respiratory |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-Respiratory |
|
| Depression | Psychiatric disorders | Non-Respiratory |
|
| Insomnia | Psychiatric disorders | Non-Respiratory |
|
| Renal colic | Renal and urinary disorders | Non-Respiratory |
|
| Menorrhagia | Reproductive system and breast disorders | Non-Respiratory |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | Non-Respiratory |
|
| Eczema | Skin and subcutaneous tissue disorders | Non-Respiratory |
|
| Asthma exacerbation prophylaxis | Surgical and medical procedures | Non-Respiratory |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D055011 |
| Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
|
| Year 4, n=12 |
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| Year 5, n=12 |
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| Year 4, n=12 |
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| Year 5, n=12 |
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| Year 4, n=12 |
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| Year 5, n=12 |
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