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| Name | Class |
|---|---|
| Olmsted Medical Center | OTHER |
| American Academy of Family Physicians National Research Network | NETWORK |
| Baim Institute for Clinical Research | OTHER |
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We are doing this study to learn how genes affect the way that people, specifically Black people, respond to treatment for asthma. Recent studies suggest that people respond differently to some asthma medications (eg Serevent, Foradil). Some people feel better when they use these inhalers, but others may not, and some people get worse. It seems that this difference shows up more often in Blacks than in Whites, which is why we are looking for Black subjects for this study. In all people, this difference seems to depend on their genes or DNA. This study is comparing the use of long acting asthma medications (Serevent, Foradil) to Tiotropium (Spiriva) for the treatment of asthma. Spiriva is used to treat chronic obstructive pulmonary disease (COPD). This study will help to see if this medication is also useful for treating asthma and whether it works better for some people than the current asthma medications.
Asthma is a chronic respiratory disease that affects over 22 million people in the United States. Asthma produces 500,000 hospital admissions and accounts for 10.1 million days of lost work in adults annually. Asthma has been designated a priority condition of the Effective Health Care Program.
Blacks bear a disproportionate burden of asthma morbidity and mortality. In its 2005 report on ethnic disparities in health care, AHRQ identified hospital admissions for asthma as the second largest disparity in quality of health care for Blacks vs. Caucasians.
Long-acting beta-agonists (LABAs) produce extended increases in airway caliber among patients with asthma via action at the beta2-adrenergic receptor (ADRB2). Adding a LABA to an inhaled corticosteroid controller medication (ICS), can decrease asthma symptoms for many individuals and appears to decrease asthma exacerbations. LABA/ICS has become the most commonly prescribed ICS containing medication.
Drugs acting at ADRB2, including LABAs, have been associated with rare loss of long-term asthma control and increased serious adverse outcomes including death and respiratory failure, even when used with ICS. The risk appears four to five-fold greater in Blacks than non-Black patients with asthma.
Consensus guidelines recommend LABAs be added to ICS in those not completely controlled on ICS alone. These recommendations are based on weighing data on the benefit demonstrated in the general population vs. the rare risk of serious adverse outcomes and balancing the apparent benefits vs. the risks of LABAs (Kramer 2009). However, it appears that LABA/ICS may be significantly less effective in Blacks than Caucasians. Comparison of studies with LABA/ICS in Blacks vs. studies where Blacks were a small minority suggests that Blacks may have much less benefit than other racial groups. Additionally, recent data (Wechsler 2009) suggest that a polymorphism at the 16th position of the ADRB2 gene identifies a group of Blacks (those homozygous for arginine (Arg16Arg)) in whom the response of adding a LABA to an ICS is further diminished. This polymorphism is present in ~20% of US Blacks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium | Experimental | Tiotropium bromide will be evaluated as a treatment for asthma. |
|
| Salmeterol or Formoterol | Active Comparator | Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug | Tiotropium bromide 18 mcg once daily for one year of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Asthma Exacerbation (Mean Number of Exacerbations/Person-year) | We summarize the survival experience using mean number of exacerbations/person-year and compare it using the log-rank test comparing kaplan-meier survival curve. | evaluated monthly (on average) via questionnaire for 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FEV1 | Average change in lung function (FEV1) evaluated by spirometry per participant over 12 months | from baseline to 12 months |
| Change in Asthma Control Questionnaire (ACQ) | Average Change in Asthma Control Score Per Participant Over 12 Months Using the Asthma Control Questionnaire (ACQ). The ACQ has six questions regarding symptoms, rescue short-acting β-agonist use and one about FEV1 % predicted. A 7-point scale (0 = no impairment, 6 = maximum impairment) is used for each question and the ACQ score is the mean value of these questions - hence between 0 (totally controlled) and 6 (severely uncontrolled). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elliot Israel, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Waters College Medical Center (Mayo) | Jacksonville | Florida | 32209 | United States | ||
| Urban Family Practice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26505596 | Result | Wechsler ME, Yawn BP, Fuhlbrigge AL, Pace WD, Pencina MJ, Doros G, Kazani S, Raby BA, Lanzillotti J, Madison S, Israel E; BELT Investigators. Anticholinergic vs Long-Acting beta-Agonist in Combination With Inhaled Corticosteroids in Black Adults With Asthma: The BELT Randomized Clinical Trial. JAMA. 2015 Oct 27;314(16):1720-30. doi: 10.1001/jama.2015.13277. | |
| 36472162 |
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Subjects on combination ICS/LABA were switched to equivalent-dose ICS monotherapy at the same time they were assigned to the Tiotropium vs. LABA arm of the study.
Initial enrollment began March 30, 2011 at the Asthma Research Center at Brigham and Women's Hospital. Subjects were recruited with print advertisements, internet postings, physician referrals, and by contacting patients in databases who asked to be contacted for studies.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tiotropium | Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment. |
| FG001 | Salmeterol or Formoterol | Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard. Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment. Formoterol: Formoterol 12 mcg twice daily for one year |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Salmeterol | Drug | Salmeterol 50 mcg twice daily for one year of treatment. |
|
|
| Formoterol | Drug | Formoterol 12 mcg twice daily for one year |
|
|
| from baseline to 12 months |
| Change in Asthma Quality of Life (AQLQ) | Average Change in Asthma Quality of Life Score Per Participant Over 12 Months Using the Asthma Quality of Life Questionnaire (AQLQ). The AQLQ has 32 questions in four domains (symptoms, activity limitation, emotional function, and environmental stimuli) and measures the functional problems that are troublesome to individuals with asthma. Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items); 7-point Likert scale (7 = not impaired at all - 1 = severely impaired); scores range 1-7, with higher scores indicating better quality of life. | from baseline to 12 months |
| Change in Asthma Symptom Utility Index (ASUI) | Average Change in Asthma Symptom Utility Score Per Participant Over 12 Months Using the Asthma Symptom Utility Index (ASUI). The ASUI is an 11-item preference-based outcome measure used in clinical trials and cost-effectiveness studies for asthma and is designed to assess the frequency and severity of cough, wheeze, dyspnea, nighttime awakenings, and side effects, weighted according to patient preferences. 4-point Likert scale to assess frequency (not at all, 1 to 3 days, 4 to 7 days, and 8 to 14 days) and severity (not applicable, mild, moderate and severe); scores range from 0 (worst possible symptoms) to 1 (no symptoms). | from baseline to 12 months |
| Change in Symptom-Free Day Questionnaire (SFDQ) | Average Change in Symptom-Free Days Per Participant Over 12 Months Using the Symptom-Free Day Questionnaire (SFDQ). The asthma symptom free day questionnaire (SFDQ) quantifies the number of days with neither daytime nor nighttime asthma symptoms, nor awakenings due to asthma symptoms. | from baseline to 12 months |
| Change in Rescue Medication Use | Average Change in Rescue Medication Use Per Participant Over 12 Months. Monthly questionnaires will evaluate the amount of rescue medication subjects have used on average, measured in puffs per day. | from baseline to 12 months |
| Change in Moderate Asthma Deterioration | Average Change in Moderate Asthma Deterioration Per Participant Over 12 Months. The definition of a moderate asthma deterioration should include one or more of the following: deterioration in symptoms, deterioration in lung function, or increased rescue bronchodilator use. These features should last for 2 days or more, but not be severe enough to warrant systemic corticosteroid use and/or hospitalization. | from baseline to 12 months |
| Marietta |
| Georgia |
| 30067 |
| United States |
| Albany Area Primary Healthcare, Inc | Newton | Georgia | 39870 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| G.A. Carmichael F.H.C. | Canton | Mississippi | 39046 | United States |
| Swope Parkway Health Center | Kansas City | Missouri | 64130 | United States |
| UNYNET - Jefferson Family Medicine | Buffalo | New York | 14215 | United States |
| Montefiore Medical Group | The Bronx | New York | 10462 | United States |
| Carolinas Medical Center - NorthEast (Lovelace) | Kannapolis | North Carolina | 28081 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Family Medicine Occupational Health Center | Shaker Heights | Ohio | 44120 | United States |
| BJHCHS - Hardeeville Medical Center | Ridgeland | South Carolina | 29936 | United States |
| Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tiotropium | Tiotropium bromide will be evaluated as a treatment for asthma. Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment. |
| BG001 | Salmeterol or Formoterol | Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard. Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment. Formoterol: Formoterol 12 mcg twice daily for one year |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Time to Asthma Exacerbation (Mean Number of Exacerbations/Person-year) | We summarize the survival experience using mean number of exacerbations/person-year and compare it using the log-rank test comparing kaplan-meier survival curve. | intention-to-treat | Posted | Mean | 95% Confidence Interval | event per person-year | evaluated monthly (on average) via questionnaire for 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in FEV1 | Average change in lung function (FEV1) evaluated by spirometry per participant over 12 months | 255 and 253 participants are missing data on change in FEV1 in the Tiotropium and Salmeterol or Formoterol arms, respectively. | Posted | Mean | 95% Confidence Interval | liters | from baseline to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Asthma Control Questionnaire (ACQ) | Average Change in Asthma Control Score Per Participant Over 12 Months Using the Asthma Control Questionnaire (ACQ). The ACQ has six questions regarding symptoms, rescue short-acting β-agonist use and one about FEV1 % predicted. A 7-point scale (0 = no impairment, 6 = maximum impairment) is used for each question and the ACQ score is the mean value of these questions - hence between 0 (totally controlled) and 6 (severely uncontrolled). | 334 and 326 participants are missing data on ACQ in the Tiotropium and Salmeterol or Formoterol arms, respectively. | Posted | Mean | 95% Confidence Interval | units on a scale | from baseline to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Asthma Quality of Life (AQLQ) | Average Change in Asthma Quality of Life Score Per Participant Over 12 Months Using the Asthma Quality of Life Questionnaire (AQLQ). The AQLQ has 32 questions in four domains (symptoms, activity limitation, emotional function, and environmental stimuli) and measures the functional problems that are troublesome to individuals with asthma. Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items); 7-point Likert scale (7 = not impaired at all - 1 = severely impaired); scores range 1-7, with higher scores indicating better quality of life. | 242 and 239 participants are missing data on AQLQ in the Tiotropium and Salmeterol or Formoterol arms, respectively. | Posted | Mean | 95% Confidence Interval | units on a scale | from baseline to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Asthma Symptom Utility Index (ASUI) | Average Change in Asthma Symptom Utility Score Per Participant Over 12 Months Using the Asthma Symptom Utility Index (ASUI). The ASUI is an 11-item preference-based outcome measure used in clinical trials and cost-effectiveness studies for asthma and is designed to assess the frequency and severity of cough, wheeze, dyspnea, nighttime awakenings, and side effects, weighted according to patient preferences. 4-point Likert scale to assess frequency (not at all, 1 to 3 days, 4 to 7 days, and 8 to 14 days) and severity (not applicable, mild, moderate and severe); scores range from 0 (worst possible symptoms) to 1 (no symptoms). | 257 and 265 participants are missing data on ASUI in the Tiotropium and Salmeterol or Formoterol arms, respectively. | Posted | Mean | 95% Confidence Interval | units on a scale | from baseline to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Symptom-Free Day Questionnaire (SFDQ) | Average Change in Symptom-Free Days Per Participant Over 12 Months Using the Symptom-Free Day Questionnaire (SFDQ). The asthma symptom free day questionnaire (SFDQ) quantifies the number of days with neither daytime nor nighttime asthma symptoms, nor awakenings due to asthma symptoms. | The instrument used to collect data proved to be unreliable. The statistic for internal consistency demonstrated less than 30% internal consistency. | Posted | from baseline to 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Rescue Medication Use | Average Change in Rescue Medication Use Per Participant Over 12 Months. Monthly questionnaires will evaluate the amount of rescue medication subjects have used on average, measured in puffs per day. | 335 and 328 participants are missing data on rescue medication use in the Tiotropium and Salmeterol or Formoterol arms, respectively. | Posted | Mean | 95% Confidence Interval | units on a scale | from baseline to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Moderate Asthma Deterioration | Average Change in Moderate Asthma Deterioration Per Participant Over 12 Months. The definition of a moderate asthma deterioration should include one or more of the following: deterioration in symptoms, deterioration in lung function, or increased rescue bronchodilator use. These features should last for 2 days or more, but not be severe enough to warrant systemic corticosteroid use and/or hospitalization. | Inadequate baseline data was collected so that the change in this variable could not be assessed. | Posted | from baseline to 12 months |
|
|
Adverse events were reported from the time of patient enrollment to up to 18 months after study completion.
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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 | Tiotropium | Tiotropium: Tiotropium bromide 18 mcg once daily for one year of treatment. | 84 | 532 | 338 | 532 | ||
| EG001 | Salmeterol or Formoterol | Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard. Salmeterol: Salmeterol 50 mcg twice daily for one year of treatment. Formoterol: Formoterol 12 mcg twice daily for one year | 69 | 538 | 342 | 538 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Angina Pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Angina Unstable | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Disorder | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Failure Congestive | Cardiac disorders | Systematic Assessment |
| ||
| Cardiomyopathy | Cardiac disorders | Systematic Assessment |
| ||
| Cardiopulmonary Failure | Cardiac disorders | Systematic Assessment |
| ||
| Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
| ||
| Coronary Artery Occlusion | Cardiac disorders | Systematic Assessment |
| ||
| Dysponea | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Goitre | Endocrine disorders | Systematic Assessment |
| ||
| Vision blurred | Eye disorders | Systematic Assessment |
| ||
| Abdominal Distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diverticulum Intestinal | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hiatus Hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Impaired Gastric Emptying | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small Intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest Discomfort | General disorders | Systematic Assessment |
| ||
| Chest Pain | General disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Oedema | General disorders | Systematic Assessment |
| ||
| Oedema Peripheral | General disorders | Systematic Assessment |
| ||
| Gallbladder Disorder | Hepatobiliary disorders | Systematic Assessment |
| ||
| Anaphylactic Reaction | Immune system disorders | Systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Systematic Assessment |
| ||
| Diverticulitis | Infections and infestations | Systematic Assessment |
| ||
| Gastrointestinal bacterial infection | Infections and infestations | Systematic Assessment |
| ||
| Localized Infection | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Viral infection | Infections and infestations | Systematic Assessment |
| ||
| Wound infection | Infections and infestations | Systematic Assessment |
| ||
| Incisional hernia | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Blood glucose increased | Investigations | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diabetic ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Costochondritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Cerebral cyst | Nervous system disorders | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Convulsion | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dysarthria | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hemiparesis | Nervous system disorders | Systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Loss of consciousness | Nervous system disorders | Systematic Assessment |
| ||
| Myelopathy | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Mental status change | Psychiatric disorders | Systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure acute | Renal and urinary disorders | Systematic Assessment |
| ||
| Menorrhagia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Postmenopausal haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Angioedema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypertensive crisis | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Peripheral arterial occlusive disease | Vascular disorders | Systematic Assessment |
| ||
| Vasculitis | Vascular disorders | Systematic Assessment |
| ||
| Disease Progression | General disorders | Systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease Progression | General disorders | Systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elliot Israel | Brigham and Women's Hospital | 6177328201 | eisrael@partners.org |
| 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
Not provided
| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| D000068299 | Salmeterol Xinafoate |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|