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The purpose of this study is to determine whether the addition of budesonide inhalation suspension (BIS) to the standard therapy of albuterol, ipratropium bromide, and systemic corticosteroids (SCS) for moderate to severe asthma flares in children reduces asthma severity more rapidly than standard therapy alone.
Context: Acute asthma is a leading cause of emergency department (ED) visits and hospitalizations. Although standard therapy for acute asthma includes systemic corticosteroids (SCS), these drugs take many hours to have an effect. Recent studies demonstrate that inhaled corticosteroids (ICS) may improve patients' asthma severity more rapidly than SCS and may decrease hospitalizations. Only a few small studies have evaluated ICS added to standard therapy for acute asthma in children.
Objective: To determine if adding the nebulized steroid budesonide to standard therapy including SCS improves patients' asthma severity faster than standard therapy alone and leads to fewer hospitalizations.
Study Design/Setting/Participants: A double-blind, randomized, controlled trial of budesonide inhalation suspension (BIS) versus placebo for children 2 to 18 years of age who present to a tertiary care, urban pediatric ED with a moderate to severe asthma flare.
Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline.
Study Measures: Differences in asthma scores, vital signs, and the need for hospitalization will be compared between treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline Placebo | Placebo Comparator | All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this placebo comparator arm will then receive 2 nebulized albuterol doses mixed with 8mL of normal saline. Finally, all patients will receive the second nebulized ipratropium dose. |
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| Budesonide Inhalaiton Suspension | Experimental | All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this intervention arm will then receive 2 nebulized albuterol doses mixed with 8mL of budesonide inhalation suspension (BIS). Finally, all patients will receive the second nebulized ipratropium dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg | Drug | Patients randomized to budesonide inhalation suspension (BIS) receive 2 nebulized albuterol sulfate (5mg/mL) doses (2mL =10mg for patients over 20kg, 1.5mL =7.5mg for patients 10-20kg) mixed with 8mL (2mg) of BIS(0.5mg/2mL). The albuterol sulfate and BIS mixture is delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM)with an oxygen flow rate of 8L/min via a tight-fitting face mask. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Change in Asthma Score 2 Hours After Intervention | The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator. | Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator |
| Mean Change in Asthma Score at 2 Hours | The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator. | Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Hospitalized | The number of patients requiring hospital admission 4 hours after budesonide/albuterol intervention or saline/albuterol comparator. All hospitalization decisions are made at the discretion of the attending physician. | within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia J Mollen, M.D. | Children's Hospital of Philadelphia | Principal Investigator |
| Bryan D. Upham, M.D. | University of New Mexico Children's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia Emergency Department | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12917930 | Background | Edmonds ML, Camargo CA Jr, Pollack CV Jr, Rowe BH. Early use of inhaled corticosteroids in the emergency department treatment of acute asthma. Cochrane Database Syst Rev. 2003;(3):CD002308. doi: 10.1002/14651858.CD002308. | |
| 9761804 | Background | Qureshi F, Pestian J, Davis P, Zaritsky A. Effect of nebulized ipratropium on the hospitalization rates of children with asthma. N Engl J Med. 1998 Oct 8;339(15):1030-5. doi: 10.1056/NEJM199810083391503. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Budesonide Inhalation Suspension (BIS) | standardized treatment with nebulized Budesonide Inhalation Suspension (BIS) |
| FG001 | Placebo (Saline) | standardized treatment with nebulized saline |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Prednisolone, prednisone, or methylprednisolone | Drug | All patients are given 2mg/kg of systemic corticosteroids (max 60mg). Patients who can tolerate pills are given oral prednisone, those who cannot are given oral prednisolone, and those who cannot tolerate oral medications are given IV methylprednisolone. |
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| Albuterol, ipratropium bromide | Drug | While guardians are approached for possible participation, patients are given a single nebulized dose of albuterol sulfate (5mg/mL) mixed with ipratropium bromide (500mcg/2.5mL). Patients who weigh 10-20kg receive 3.75mg of albuterol. Patients over 20kg receive 5mg of albuterol. All patients receive 500mcg of ipratropium bromide. Albuterol sulfate and ipratropium bromide are delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM)with an oxygen flow rate of 8L/min via a tight-fitting face mask. |
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| Ipratropium bromide | Drug | 500 mcg/2.5mL. All patients receive a final dose of ipratropium bromide after the intervention or placebo. The ipratropium bromide is delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM) with an oxygen flow rate of 8L/minute via a tight-fitting face mask. |
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| Change in Mean Heart Rate |
Mean of heart rate in beats per minute before treatment minus mean of heart rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol |
| From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator |
| Mean Change in Respiratory Rate. | Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator. | Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator |
| Oxygen Saturation. | Mean oxygen saturation (non-invasive pulse-oximetry, % hemoglobin saturation) 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator minus mean oxygen saturation before treatment. | 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator |
| Number of Subjects Remaining in the Severe Asthma Category | Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who remained in this category 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. | From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator |
| Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category | Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the moderate category (Asthma Severity score 8-11) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. | From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator |
| Number of Subjects Moving From the Severe Asthma to Mild Asthma Category | Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the mild category (Asthma Severity score 5-7) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. | From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator |
| Relapse / Readmission Numbers. | Participants admitted to the hospital within 5 days of the ED visit | within 5 days of ED visit |
| Number of Participants With Adverse Events (Non-serious). | within 30 days of the ED visit |
| Serious Adverse Events | Serious Adverse Events | 0-5 days |
| 9523927 | Background | Sung L, Osmond MH, Klassen TP. Randomized, controlled trial of inhaled budesonide as an adjunct to oral prednisone in acute asthma. Acad Emerg Med. 1998 Mar;5(3):209-13. doi: 10.1111/j.1553-2712.1998.tb02614.x. |
| 10503681 | Background | Devidayal, Singhi S, Kumar L, Jayshree M. Efficacy of nebulized budesonide compared to oral prednisolone in acute bronchial asthma. Acta Paediatr. 1999 Aug;88(8):835-40. doi: 10.1080/08035259950168748. |
| 7574132 | Background | Scarfone RJ, Loiselle JM, Wiley JF 2nd, Decker JM, Henretig FM, Joffe MD. Nebulized dexamethasone versus oral prednisone in the emergency treatment of asthmatic children. Ann Emerg Med. 1995 Oct;26(4):480-6. doi: 10.1016/s0196-0644(95)70118-4. |
| 16261956 | Background | Nuhoglu Y, Atas E, Nuhoglu C, Iscan M, Ozcay S. Acute effect of nebulized budesonide in asthmatic children. J Investig Allergol Clin Immunol. 2005;15(3):197-200. |
| 10974132 | Background | Schuh S, Reisman J, Alshehri M, Dupuis A, Corey M, Arseneault R, Alothman G, Tennis O, Canny G. A comparison of inhaled fluticasone and oral prednisone for children with severe acute asthma. N Engl J Med. 2000 Sep 7;343(10):689-94. doi: 10.1056/NEJM200009073431003. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Budesonide Inhalation Suspension (BIS) | standardized treatment with nebulized Budesonide Inhalation Suspension (BIS) |
| BG001 | Placebo (Saline) | standardized treatment with nebulized saline |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Median Change in Asthma Score 2 Hours After Intervention | The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator. | 88 of the 91 patients randomized to budesonide were evaluable for the primary outcome (1 was discharged home, 1 had no 2 hour score, and 1 did not have a valid initial score). 81 of the 89 patients randomized to placebo were evaluable (1 inadvertently received standard therapy, 2 withdrew, and 5 were admitted before a 2 hour score evaluation). | Posted | Mar 2010 | Median | Full Range | Units on a scale | Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator |
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| Secondary | Number of Patients Hospitalized | The number of patients requiring hospital admission 4 hours after budesonide/albuterol intervention or saline/albuterol comparator. All hospitalization decisions are made at the discretion of the attending physician. | Posted | Number | Participants | within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo |
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| Secondary | Change in Mean Heart Rate | Mean of heart rate in beats per minute before treatment minus mean of heart rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol | Posted | Jun 2010 | Mean | 95% Confidence Interval | Beats per minute | From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator |
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| Secondary | Mean Change in Respiratory Rate. | Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator. | Posted | Jun 2010 | Mean | 95% Confidence Interval | Breaths per minute | Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator |
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| Secondary | Oxygen Saturation. | Mean oxygen saturation (non-invasive pulse-oximetry, % hemoglobin saturation) 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator minus mean oxygen saturation before treatment. | Posted | Jun 2010 | Mean | 95% Confidence Interval | Percent Hemoglobin Saturation | 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator |
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| Secondary | Number of Subjects Remaining in the Severe Asthma Category | Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who remained in this category 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. | Number of patients who presented in the severe asthma category (Asthma Score 12-15) who remained in that category 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator. | Posted | Jun 2010 | Number | Participants | From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator |
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| Secondary | Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category | Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the moderate category (Asthma Severity score 8-11) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. | Number of patients who presented in the severe asthma category (Asthma Score 12-15) who moved to the moderate asthma category (Asthma Score 8-11) 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator. | Posted | Jun 2010 | Number | Participants | From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator |
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| Secondary | Number of Subjects Moving From the Severe Asthma to Mild Asthma Category | Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the mild category (Asthma Severity score 5-7) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. | Number of patients who presented in the severe asthma category (Asthma Score 12-15) who moved to the moderate asthma category (Asthma Score 8-11) 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator. | Posted | Jun 2010 | Number | Participants | From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator |
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| Secondary | Relapse / Readmission Numbers. | Participants admitted to the hospital within 5 days of the ED visit | 89 of the 91 patients randomized to BIS were available for follow-up. 85 of the 89 patients randomized to placebo were available. | Posted | Number | Participants | within 5 days of ED visit |
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| Primary | Mean Change in Asthma Score at 2 Hours | The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator. | 88 of the 91 patients randomized to budesonide were evaluable for the primary outcome (1 was discharged home, 1 had no 2 hour score, and 1 did not have a valid initial score). 81 of the 89 patients randomized to placebo were evaluable (1 inadvertently received standard therapy, 2 withdrew, and 5 were admitted before a 2 hour score evaluation). | Posted | Mar 2010 | Mean | 95% Confidence Interval | Units on a scale | Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator |
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| Secondary | Number of Participants With Adverse Events (Non-serious). | Of the 180 patients randomized, 91 were to BIS, 89 were to placebo. Two patients were lost to follow-up in the BIS group and 4 in the placebo group. | Posted | Mar 2010 | Number | Participants | within 30 days of the ED visit |
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| Secondary | Serious Adverse Events | Serious Adverse Events | 89 of the 91 patients randomized to BIS were available for follow-up. 85 of the 89 patients randomized to placebo were available. | Posted | Number | participants | 0-5 days |
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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 | Budesonide Inhalation Suspension (BIS) | standardized treatment with nebulized Budesonide Inhalation Suspension (BIS) | 3 | 91 | 30 | 91 | ||
| EG001 | Placebo (Saline) | standardized treatment with nebulized saline | 2 | 88 | 27 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization within 5 days of Emergency Department discharge home | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Increased level of care | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rhinorrhea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| headache | Nervous system disorders | Non-systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| sore throat | Infections and infestations | Non-systematic Assessment |
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| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| emesis | Gastrointestinal disorders | Non-systematic Assessment |
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| fever | Infections and infestations | Non-systematic Assessment |
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| epistaxis | Blood and lymphatic system disorders | Non-systematic Assessment |
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| ear infection | Infections and infestations | Non-systematic Assessment |
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| respiratory infection | Infections and infestations | Non-systematic Assessment |
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| stomach ache | Gastrointestinal disorders | Non-systematic Assessment |
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| chest pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| leg pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia J. Mollen | The Children's Hospital of Philadelphia | 215-590-4410 | mollenc@email.chop.edu |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D004630 | Emergencies |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| D019819 | Budesonide |
| D011239 | Prednisolone |
| D011241 | Prednisone |
| D008775 | Methylprednisolone |
| D009241 | Ipratropium |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011244 | Pregnadienediols |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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| >=65 years |
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| Male |
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