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The objective of this randomized, double blind, sham-controlled study is to demonstrate the safety and effectiveness of the Alair System in a population of subjects with severe asthma who are still symptomatic despite being managed on conventional therapy of high doses of inhaled corticosteroids and long-acting β2-agonists.
The primary efficacy endpoint will be the difference between Study groups in the change in Asthma Quality of Life Questionnaire (AQLQ) score from Baseline and the average score from the 6-, 9-, and 12-month follow-up visits.
All other outcome measures assessed at 12 months post-treatment.
This will be a multicenter, randomized, double-blind, sham-controlled study comparing the effects of treatment with the Alair System to conventional therapy of inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA).
A Bayesian adaptive approach to sample size selection is used with a randomization scheme of 2:1 (two Alair Group Subjects for every one Control Group Subject).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alair | Experimental | Treatment of airways with the Alair System |
|
| Sham | Sham Comparator | Sham treatment of airways |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alair System | Device | Treatment of airways with the Alair System |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline) | Change between Baseline and the average of 6-, 9-, and 12-month Follow-Up Visits. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). An increase in the AQLQ score indicates a better quality of life. The average of the 6-, 9-, and 12-month differences in the AQLQ Score are referred to as the "Integrated AQLQ Score." | Baseline, 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Symptom-Free Days (Change From Baseline) | Change between Baseline and 12-month Follow-Up Visit. 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. | Baseline, 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Severe Exacerbations Requiring Systemic Corticosteroids | Rate of occurrence of worsening of asthma requiring treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a Subject taking maintenance oral corticosteroids at Study entry. | Baseline, 12 Months |
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 |
|---|---|---|---|---|---|---|
| Pulmonary Associates, PA | Phoenix | Arizona | 85020 | United States | ||
| University of Southern California, Adult Asthma and Allergy Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24125149 | Background | 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. | |
| 23998657 |
| Label | URL |
|---|---|
| The AIR2 Extension Study (PAS1) contains the Year 2 to Year 5 Study Results. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alair | Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists. |
| FG001 | Sham | Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized |
|
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| Alair System |
| Device |
Sham treatment of airways with the Alair System |
|
| Total Symptom Score (Change From Baseline) |
Change from Baseline and 12-month Follow-Up Visit. 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. A lower Total Symptom score represents better asthma control. |
| Baseline, 12 Months |
| Number of Puffs of Rescue Medication Used (Change From Baseline) | Change between Baseline and 12-Month Follow-up Visit. Average number of puffs per week. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms. | Baseline, 12 Months |
| Percent Days Rescue Medication Used (Change From Baseline) | Change between Baseline and 12-Month Follow-up Visit. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms. | Baseline, 12 Months |
| Asthma Control Questionnaire (ACQ) Score (Change From Baseline) | Change between Baseline and 12-month Follow-Up Visit. The ACQ is a self-administered patient questionnaire that also includes the patient's FEV1 value (% Predicted) 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 (Better) to 6 (Worse). A decrease in the ACQ score indicates better asthma control. | Baseline, 12 Months |
| Morning Peak Expiratory Flow (amPEF) (Change From Baseline) | Change between Baseline and 12-month Follow-Up Visit. The peak expiratory flow rate measures the maximal rate at which a person can exhale air. | Baseline, 12 Months |
| Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline) | Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity. | Baseline, 12 Months |
| Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline) | Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity. | Baseline, 12 Months |
| Percentage of Subjects With Severe Exacerbations Requiring Systemic Corticosteroids | Percent of subjects experiencing worsening of asthma requiring treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a Subject taking maintenance oral corticosteroids at Study entry. | Baseline, 12 Months |
| Days Lost From Work/School/Other Activities Due to Asthma | 12 Months |
| Unscheduled Physician Office Visits for Respiratory Symptoms | 12 Months |
| Emergency Room Visits for Respiratory Symptoms | 12 Months |
| Hospitalizations for Respiratory Symptoms | 12 Months |
| Los Angeles |
| California |
| 90033 |
| United States |
| National Jewish Medical and Research Center | Denver | Colorado | 80206 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Peoria Pulmonary Associates, Ltd. | Peoria | Illinois | 61603 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Veritas Clinical Specialties | Topeka | Kansas | 66606 | United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | United States |
| Brigham and Womens's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Henry Ford Medical Center | Detroit | Michigan | 48202 | United States |
| HealthPartners Specialty Center, Lung and Sleep Health | Saint Paul | Minnesota | 55101 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110-1093 | United States |
| Saint Vincent Catholic Medical Center | New York | New York | 10011 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Hospital of the University of Pennyslvania | Philadelphia | Pennsylvania | 19104 | United States |
| Clinical Research Solutions, PC - Baptist Hospitals of East Tennesse | Knoxville | Tennessee | 37920 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Virginia Hospital Center | Arlington | Virginia | 22205-3698 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| University of Wisconsin Hospital | Madison | Wisconsin | 53792 | United States |
| John Hunter Hospital | New Lambton Heights | New South Wales | 2035 | Australia |
| Sir Charles Gairdner Hospital | Perth | Western Australia | 6009 | Australia |
| Royal Adelaide Hospital | Adelaide | Australia |
| Hospital Sao Lucas da PUCRS | Porto Alegre | Rio Grande do Sul | CEP 90610-00 | Brazil |
| Irmandade Santa Casa de Miscericordia de Porto Alegre | Porto Alegre | CEP 90035-074 | Brazil |
| Hospital Universitario Clementino Fraga Filho | Rio de Janeiro | Brazil |
| Faculdade da Medicina do ABC | São Paulo | CEP 09060-650 | Brazil |
| Firestone Institute of Respiratory Health, St. Joseph's Healthcare | Hamilton | Ontario | L8N 4A6 | Canada |
| Montreal Chest Institute, McGill University | Montreal | Quebec | H2X 2P4 | Canada |
| Hopital Laval, Centre de Pneumologie | Sainte-Foy | Quebec | G1V 4GS | Canada |
| Odense Universitets Hospital, University of Odense | Odense | 5000 Odense C | Denmark |
| Universitair Medisch Centrum | Groningen | 9700 RB | Netherlands |
| Gartnavel General Hospital, University of Glasgow | Glasgow | Scotland | G12 0YN | United Kingdom |
| Birmingham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
| Glenfield General Hospital, Univ. Hospitals of Leicester | Leicester | LE3 9QP | United Kingdom |
| Chelsea & Westminster Healthcare NHS Trust | London | SW10 9NH | United Kingdom |
| Northwest Lung Research Center, Univ. of Manchester | Manchester | M23 9LT | United Kingdom |
| Wechsler ME, Laviolette M, Rubin AS, Fiterman J, Lapa e Silva JR, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Hales JB, McEvoy C, Slebos DJ, Holmes M, Phillips MJ, Erzurum SC, Hanania NA, Sumino K, Kraft M, Cox G, Sterman DH, Hogarth K, Kline JN, Mansur AH, Louie BE, Leeds WM, Barbers RG, Austin JH, Shargill NS, Quiring J, Armstrong B, Castro M; Asthma Intervention Research 2 Trial Study Group. Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma. J Allergy Clin Immunol. 2013 Dec;132(6):1295-302. doi: 10.1016/j.jaci.2013.08.009. Epub 2013 Aug 30. |
| 19815809 | Result | Castro M, Rubin AS, Laviolette M, Fiterman J, De Andrade Lima M, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Duhamel DR, McEvoy C, Barbers R, Ten Hacken NH, Wechsler ME, Holmes M, Phillips MJ, Erzurum S, Lunn W, Israel E, Jarjour N, Kraft M, Shargill NS, Quiring J, Berry SM, Cox G; AIR2 Trial Study Group. Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial. Am J Respir Crit Care Med. 2010 Jan 15;181(2):116-24. doi: 10.1164/rccm.200903-0354OC. Epub 2009 Oct 8. |
| 21704887 | Derived | Castro M, Rubin A, Laviolette M, Hanania NA, Armstrong B, Cox G; AIR2 Trial Study Group. Persistence of effectiveness of bronchial thermoplasty in patients with severe asthma. Ann Allergy Asthma Immunol. 2011 Jul;107(1):65-70. doi: 10.1016/j.anai.2011.03.005. Epub 2011 Apr 14. |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period |
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| Post-Treatment Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Alair | Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists. |
| BG001 | Sham | Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline) | Change between Baseline and the average of 6-, 9-, and 12-month Follow-Up Visits. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). An increase in the AQLQ score indicates a better quality of life. The average of the 6-, 9-, and 12-month differences in the AQLQ Score are referred to as the "Integrated AQLQ Score." | Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, 12 Months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percent Symptom-Free Days (Change From Baseline) | Change between Baseline and 12-month Follow-Up Visit. 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. | Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy. | Posted | Mean | Standard Deviation | Percent Change | Baseline, 12 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Total Symptom Score (Change From Baseline) | Change from Baseline and 12-month Follow-Up Visit. 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. A lower Total Symptom score represents better asthma control. | Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, 12 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Puffs of Rescue Medication Used (Change From Baseline) | Change between Baseline and 12-Month Follow-up Visit. Average number of puffs per week. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms. | Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy. | Posted | Jun 2010 | Mean | Standard Deviation | Puffs/7 Days | Baseline, 12 Months |
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| Secondary | Percent Days Rescue Medication Used (Change From Baseline) | Change between Baseline and 12-Month Follow-up Visit. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms. | Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy. | Posted | Jun 2010 | Mean | Standard Deviation | Percent Change | Baseline, 12 Months |
|
| ||||||||||||||||||||||||||||
| Secondary | Asthma Control Questionnaire (ACQ) Score (Change From Baseline) | Change between Baseline and 12-month Follow-Up Visit. The ACQ is a self-administered patient questionnaire that also includes the patient's FEV1 value (% Predicted) 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 (Better) to 6 (Worse). A decrease in the ACQ score indicates better asthma control. | Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy. | Posted | Jun 2010 | Mean | Standard Deviation | Units on a scale | Baseline, 12 Months |
|
| ||||||||||||||||||||||||||||
| Secondary | Morning Peak Expiratory Flow (amPEF) (Change From Baseline) | Change between Baseline and 12-month Follow-Up Visit. The peak expiratory flow rate measures the maximal rate at which a person can exhale air. | Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy. | Posted | Jun 2010 | Mean | Standard Deviation | L/Min | Baseline, 12 Months |
|
| ||||||||||||||||||||||||||||
| Secondary | Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline) | Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity. | Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy. | Posted | Mean | Standard Deviation | Percent Change | Baseline, 12 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline) | Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity. | Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy. | Posted | Mean | Standard Deviation | Percent Change | Baseline, 12 Months |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Rate of Severe Exacerbations Requiring Systemic Corticosteroids | Rate of occurrence of worsening of asthma requiring treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a Subject taking maintenance oral corticosteroids at Study entry. | Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy. | Posted | Mean | Standard Deviation | Events/Subject/Year | Baseline, 12 Months |
|
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| Other Pre-specified | Percentage of Subjects With Severe Exacerbations Requiring Systemic Corticosteroids | Percent of subjects experiencing worsening of asthma requiring treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a Subject taking maintenance oral corticosteroids at Study entry. | Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy. | Posted | Number | Percent of Subjects | Baseline, 12 Months |
|
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| Other Pre-specified | Days Lost From Work/School/Other Activities Due to Asthma | Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy. | Posted | Mean | Standard Deviation | Days/Subject/Year | 12 Months |
|
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| Other Pre-specified | Unscheduled Physician Office Visits for Respiratory Symptoms | Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy. | Posted | Mean | Standard Deviation | Events/Subject/Year | 12 Months |
|
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| Other Pre-specified | Emergency Room Visits for Respiratory Symptoms | Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy. | Posted | Mean | Standard Deviation | Events/Subject/Year | 12 Months |
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| Other Pre-specified | Hospitalizations for Respiratory Symptoms | Posted | Number | Events/Subject/Year | 12 Months |
|
|
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Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
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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) | Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Airways treated with the Alair System. | 19 | 190 | 176 | 190 | ||
| EG001 | Sham (Treatment Period) | Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Sham treatment. | 4 | 98 | 82 | 98 | ||
| EG002 | Alair (Post-Treatment Period) | Six weeks after the last bronchoscopy session until 12 Months. Airways treated with the Alair System. | 12 | 187 | 157 | 187 | ||
| EG003 | Sham (Post-Treatment Period) | Six weeks after the last bronchoscopy session until 12 Months. Sham treatment. | 10 | 98 | 86 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders |
| |||
| Asthma (Multiple Symptoms) | Respiratory, thoracic and mediastinal disorders |
| |||
| Atelectasis | Respiratory, thoracic and mediastinal disorders |
| |||
| Back Pain | Musculoskeletal and connective tissue disorders |
| |||
| Breast Cancer Stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Chest Pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Cholecystitis Acute | Hepatobiliary disorders |
| |||
| Chondrocalcinosis Pyrophosphate | Musculoskeletal and connective tissue disorders |
| |||
| Depression | Psychiatric disorders |
| |||
| Fatigue | General disorders |
| |||
| Forced Expiratory Volume Decreased | Investigations |
| |||
| Foreign Body Aspiration | Respiratory, thoracic and mediastinal disorders |
| |||
| Haematoma Evacuation | Surgical and medical procedures |
| |||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Hemiparesis | Nervous system disorders |
| |||
| Hysterectomy | Surgical and medical procedures |
| |||
| Lower Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders |
| |||
| Migraine | Nervous system disorders |
| |||
| Osteomyelitis | Infections and infestations |
| |||
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
| |||
| Road Traffic Accident | Injury, poisoning and procedural complications |
| |||
| Thermal Burn | Injury, poisoning and procedural complications |
| |||
| Umbilical Hernia | Gastrointestinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Sinusitis | Respiratory, thoracic and mediastinal disorders |
| |||
| Asthma (Multiple Symptoms) | Respiratory, thoracic and mediastinal disorders |
| |||
| Back Pain | Musculoskeletal and connective tissue disorders |
| |||
| Bronchitis | 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 |
| |||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Influenza | Infections and infestations |
| |||
| Lower Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders |
| |||
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders |
| |||
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Productive Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Rhinitis | Respiratory, thoracic and mediastinal disorders |
| |||
| Sinusitis | Respiratory, thoracic and mediastinal disorders |
| |||
| Throat Irritation | Respiratory, thoracic and mediastinal disorders |
| |||
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders |
| |||
| Viral Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders |
| |||
| Wheezing | Respiratory, thoracic and mediastinal disorders |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Narinder S Shargill, PhD | Asthmatx, Inc. | 408-419-0100 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
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| Withdrawal by Subject |
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| Male |
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| Canada |
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| Brazil |
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| United Kingdom |
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| Netherlands |
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| Australia |
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