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The purpose of this study is to demonstrate the effectiveness and safety of the Alair System for the treatment of asthma.
This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy. One-hundred and ten subjects will be randomized 1:1 to either the Alair Group (Medical management + Alair treatment),or Control Group (Medical management only).
Multicenter, randomized, controlled clinical trial conducted at 11 Investigational Sites in 4 countries (Canada, United Kingdom, Denmark, and Brazil).
Subjects underwent Baseline evaluations, Alair treatments or Control Visits, and follow-up evaluations at 12-Weeks, 6-Months, and 12-Months after the last Treatment or Control Visit. In order to maximize the power of the study, Baseline and Follow-up testing was conducted in 2 parts. In the first part subjects continued to take their asthma maintenance medications (inhaled corticosteroids (ICS) and long acting β2-agonists (LABA) during the test period. This is designated as the "ON-LABA" Phase. Following ON-LABA testing subjects were asked to abstain from LABA for the second part of the testing, and these results are designated as the "OFF-LABA" Phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alair Group | Experimental | Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System. |
|
| Control Group | Active Comparator | Conventional therapy with ICS+LABA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchial thermoplasty with the Alair System | Procedure | Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mild Exacerbation Rate (OFF-LABA) (Change From Baseline) | Average change from Baseline across 12-Week, 6-Month, and 12-Month (OFF-LABA) Follow-up visits. A mild exacerbation was defined as 2 consecutive days when at least one of the following occurs: 1. Morning peak expiratory flow falls at least 20% below the average morning peak flow recorded during the 7 days immediately prior to Enrollment testing; 2. More than 3 more puffs of rescue short acting bronchodilator are required than the average usage during the 7 days immediately prior to Enrollment testing; 3. Awakening at night with asthma symptoms. | Baseline, 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline) | Percent change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in pre-bronchodilator forced expiratory volume in 1 second (FEV1) (percent predicted). | Baseline, 12 Months |
| Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Narinder S Shargill, PhD | Asthmatx, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17392302 | Derived | Cox G, Thomson NC, Rubin AS, Niven RM, Corris PA, Siersted HC, Olivenstein R, Pavord ID, McCormack D, Chaudhuri R, Miller JD, Laviolette M; AIR Trial Study Group. Asthma control during the year after bronchial thermoplasty. N Engl J Med. 2007 Mar 29;356(13):1327-37. doi: 10.1056/NEJMoa064707. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alair Group | Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen. |
| FG001 | Control Group | Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized |
| |||||||||||||
| Treatment Period |
| |||||||||||||
| Post-Treatment Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alair Group | Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen. |
| BG001 | Control Group |
| 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 | Mild Exacerbation Rate (OFF-LABA) (Change From Baseline) | Average change from Baseline across 12-Week, 6-Month, and 12-Month (OFF-LABA) Follow-up visits. A mild exacerbation was defined as 2 consecutive days when at least one of the following occurs: 1. Morning peak expiratory flow falls at least 20% below the average morning peak flow recorded during the 7 days immediately prior to Enrollment testing; 2. More than 3 more puffs of rescue short acting bronchodilator are required than the average usage during the 7 days immediately prior to Enrollment testing; 3. Awakening at night with asthma symptoms. | Posted | Mean | Standard Deviation | Exacerbations/Subject/Week | Baseline, 12 Months |
|
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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 (Treatment Period) | From first Treatment visit through 6 weeks after last Treatment visit. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain Upper | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Chest Sound | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark G. Grubb | Boston Scientific Corporation | 412-749-1423 | Mark.Grubb@bsci.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D012130 | Respiratory Hypersensitivity |
| 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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| Conventional therapy with ICS+LABA | Drug | Conventional therapy with ICS+LABA. |
|
Percent change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in post-bronchodilator forced expiratory volume in 1 second (FEV1) (percent predicted). |
| Baseline, 12 Months |
| Methacholine PC20 (Change From Baseline) | Change from Baseline at 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in "PC20" - provocative concentration of Provocholine (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from baseline. The patient inhales an aerosol of one or more concentrations of methacholine. The lower the concentration of methacholine that provokes a 20% (or greater) fall in FEV1, the more "responsive" or "hyperresponsive" the airways are. Conversely, a rise in methacholine PC20 indicates airways that have become less reactive. | Baseline, 12 Months |
| Peak Expiratory Flow (Morning and Evening) (Change From Baseline) | Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in morning and evening Peak Expiratory Flow (PEF). The peak expiratory flow rate measures the maximal rate at which a person can exhale air. | Baseline, 12 Months |
| Asthma Control Questionnaire (ACQ) Score (Change From Baseline) | Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in Asthma Control Questionnaire (ACQ) Score. The ACQ is a self-administered patient questionnaire that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient's asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (best) to 6 (worst) and averaged, resulting in a total score from 0 to 6. A decrease in the ACQ score indicates better asthma control. | Baseline, 12 Months |
| Use of Rescue Medications (Change From Baseline) | Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in use of rescue medications (short acting bronchodilators) measured in puffs per week. Subjects recorded their use of rescue medication for asthma symptoms in their Daily Diary throughout the study. | Baseline, 12 Months |
| Use of Maintenance Medications (Change From Baseline) | Change from Baseline at 12-Months (OFF-LABA) Follow-up Visit in use of maintenance medications (inhaled corticosteroids and/or long-acting beta-agonists). | Baseline, 12 Months |
| Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline) | Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in AQLQ score. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). The AQLQ score is the mean of the scores from the 32 individual questions. An increase in the AQLQ score indicates a better quality of life. A within-subject change in score of 0.5 represents the minimal important difference (MID). | Baseline, 12 Months |
| Total Symptom Score (Change From Baseline) | Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in Total Symptom Score. Total Symptom Score comprises the sum of six asthma symptom measurements. Each symptom 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. A lower Total Symptom score represents better asthma control. | Baseline, 12 Months |
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Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Group | Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen. |
|
|
| Secondary | Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline) | Percent change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in pre-bronchodilator forced expiratory volume in 1 second (FEV1) (percent predicted). | Posted | Mean | Standard Deviation | Percent Change | Baseline, 12 Months |
|
|
|
| Secondary | Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline) | Percent change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in post-bronchodilator forced expiratory volume in 1 second (FEV1) (percent predicted). | Posted | Mean | Standard Deviation | Percent Change | Baseline, 12 Months |
|
|
|
| Secondary | Methacholine PC20 (Change From Baseline) | Change from Baseline at 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in "PC20" - provocative concentration of Provocholine (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from baseline. The patient inhales an aerosol of one or more concentrations of methacholine. The lower the concentration of methacholine that provokes a 20% (or greater) fall in FEV1, the more "responsive" or "hyperresponsive" the airways are. Conversely, a rise in methacholine PC20 indicates airways that have become less reactive. | Posted | Geometric Mean | 95% Confidence Interval | mg/mL | Baseline, 12 Months |
|
|
|
| Secondary | Peak Expiratory Flow (Morning and Evening) (Change From Baseline) | Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in morning and evening Peak Expiratory Flow (PEF). The peak expiratory flow rate measures the maximal rate at which a person can exhale air. | Posted | Mean | Standard Deviation | L/min | Baseline, 12 Months |
|
|
|
| Secondary | Asthma Control Questionnaire (ACQ) Score (Change From Baseline) | Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in Asthma Control Questionnaire (ACQ) Score. The ACQ is a self-administered patient questionnaire that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient's asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (best) to 6 (worst) and averaged, resulting in a total score from 0 to 6. A decrease in the ACQ score indicates better asthma control. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, 12 Months |
|
|
|
| Secondary | Use of Rescue Medications (Change From Baseline) | Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in use of rescue medications (short acting bronchodilators) measured in puffs per week. Subjects recorded their use of rescue medication for asthma symptoms in their Daily Diary throughout the study. | Posted | Mean | Standard Deviation | Puffs/7 Days | Baseline, 12 Months |
|
|
|
| Secondary | Use of Maintenance Medications (Change From Baseline) | Change from Baseline at 12-Months (OFF-LABA) Follow-up Visit in use of maintenance medications (inhaled corticosteroids and/or long-acting beta-agonists). | Posted | Number | Subjects | Baseline, 12 Months |
|
|
|
| Secondary | Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline) | Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in AQLQ score. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). The AQLQ score is the mean of the scores from the 32 individual questions. An increase in the AQLQ score indicates a better quality of life. A within-subject change in score of 0.5 represents the minimal important difference (MID). | Posted | Mean | Standard Deviation | Units on a scale | Baseline, 12 Months |
|
|
|
| Secondary | Total Symptom Score (Change From Baseline) | Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in Total Symptom Score. Total Symptom Score comprises the sum of six asthma symptom measurements. Each symptom 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. A lower Total Symptom score represents better asthma control. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, 12 Months |
|
|
|
| 4 |
| 55 |
| 53 |
| 55 |
| EG001 | Control (Treatment Period) | From first Control visit through 6 weeks after last Control visit. | 4 | 54 | 43 | 54 |
| EG002 | Alair (Post-Treatment Period) | From 6 weeks after last Treatment visit through 1 year. | 5 | 55 | 52 | 55 |
| EG003 | Control (Post-Treatment Period) | From 6 weeks after last Control visit through 1 year. | 4 | 54 | 46 | 54 |
| Asthma | Respiratory, thoracic and mediastinal disorders |
|
| Atrial Fibrillation | Cardiac disorders |
|
| Calculus Urinary | Renal and urinary disorders |
|
| Chest Pain | Respiratory, thoracic and mediastinal disorders |
|
| Collapse Of Lung (Partial Collapse Of Left Upper Lobe) | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
|
| Gastritis | Gastrointestinal disorders |
|
| Headache | Nervous system disorders |
|
| Lung Infection Pseudomonal | Respiratory, thoracic and mediastinal disorders |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders |
|
| Sepsis | Infections and infestations |
|
| Spinal Fracture | Injury, poisoning and procedural complications |
|
| Anxiety | Psychiatric disorders |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Bronchial Irritation | Respiratory, thoracic and mediastinal disorders |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders |
|
| Chest Discomfort | Respiratory, thoracic and mediastinal disorders |
|
| Chest Pain | Respiratory, thoracic and mediastinal disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Dizziness | Nervous system disorders |
|
| Dyspepsia | Gastrointestinal disorders |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnoea Exacerbated | Respiratory, thoracic and mediastinal disorders |
|
| Ear Infection | Infections and infestations |
|
| Fatigue | General disorders |
|
| Headache | Nervous system disorders |
|
| Hypersensitivity | Immune system disorders |
|
| Influenza | Infections and infestations |
|
| Influenza Like Illness | General disorders |
|
| Migraine | Nervous system disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Nocturnal Dyspnoea | Respiratory, thoracic and mediastinal disorders |
|
| Oral Candidiasis | Infections and infestations |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders |
|
| Pyrexia | General disorders |
|
| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders |
|
| Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders |
|
| Sputum Discoloured | Respiratory, thoracic and mediastinal disorders |
|
| Tendonitis | Musculoskeletal and connective tissue disorders |
|
| Tonsillitis | Infections and infestations |
|
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders |
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| Urinary Tract Infection | Infections and infestations |
|
| Vomiting | Gastrointestinal disorders |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders |
|
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| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D055011 |
| Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| OFF-LABA at 6 Months |
|
| OFF-LABA at 12 Months |
|
| OFF-LABA at 6 Months |
|
| OFF-LABA at 12 Months |
|
| OFF-LABA at 12 Months |
|
| Morning PEF: OFF-LABA at 6 Months |
|
| Morning PEF: OFF-LABA at 12 Months |
|
| Evening PEF: ON-LABA at 12 Weeks |
|
| Evening PEF: OFF-LABA at 12 Weeks |
|
| Evening PEF: OFF-LABA at 6 Months |
|
| Evening PEF: OFF-LABA at 12 Months |
|
| OFF-LABA at 6 Months |
|
| OFF-LABA at 12 Months |
|
| OFF-LABA at 6 Months |
|
| OFF-LABA at 12 Months |
|
| Decrease in ICS Dosage |
|
| OFF-LABA at 6 Months |
|
| OFF-LABA at 12 Months |
|
| OFF-LABA at 6 Months |
|
| OFF-LABA at 12 Months |
|