Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Background: The bronchodilator therapy is an essential component of the management of asthma exacerbation. The delivery of bronchodilators to the lungs in asthma exacerbations is usually achieved through nebulization (creating small particles to be inhaled). The commonly used nebulizer device is a small volume jet nebulizer which has not been consistently reliable in delivering bronchodilator therapy. The Aeroneb nebulizer device is a FDA approved device which produces consistently respirable sized particles which could potentially result in better bronchodilator effect than the standard jet nebulizer.
Aim: To study whether the Aeroneb nebulizer is more effective than a small volume jet nebulizer in delivering bronchodilators during a severe asthma exacerbation.
Experimental design: Patients will be randomized (like a flip of a coin) to receive bronchodilator therapy as per the emergency room protocol either via small volume jet nebulizer or Aeroneb nebulizer.
Subjects: Adult patients between age of 18 and 55 years who present to the emergency room with severe asthma exacerbation with peak expiratory flow rate <50% of predicted.
Study procedure: When enrolled in the study and after randomization, we will then collect data that is standard for the hospital like heart rate, blood pressure and breathing indices and also some non-routine things like some scoring scales for shortness of breath and serial measurements of peak expiratory flow rate. We anticipate that the Aeroneb device will be more effective in delivering bronchodilator medication and thus more effective in managing asthma exacerbations.
In order to blind the treating physician and the recording investigator, a sign "treatment in progress" will be displayed at the outdoor of the ER room when the patient is getting the bronchodilator treatment. The nebulizer devices will be placed in the box between the bronchodilator treatment sessions. The physician and the recording investigator will be asked if possible to see the patients only when the sign is taken off the outdoor.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Small volume jet nebulizer | Active Comparator | Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol. |
|
| Aeroneb nebulizer | Experimental | Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aeroneb nebulizer | Device | The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation. The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Mean of Peak Expiratory Flow Rate (PEFR) Percentage of Predicted Baseline at 30 Minutes After the Initial Bronchodilator Treatment | Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in the PEFR Percentage of Predicted Baseline to Disposition | Change in the PEFR percent predicted from the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group. | Initial bronchodilator treatment to disposition, an average of 4 hours |
| Percentage Change in the Forced Expiratory Volume (FEV1) Percentage of Predicted Baseline to Disposition |
| Measure | Description | Time Frame |
|---|---|---|
| The Total Dose of Ipratropium Used in Each Group During ED Stay | Ipratropium is used to prevent wheezing, shortness of breath, coughing and chest tightness in people with chronic obstructive pulmonary disease, chronic bronchitis, and emphysema. It is a bronchodilator which relaxes and opens the air passages to the lungs to make breathing easier. | Length of stay in the ER - up to one day |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicholas S Hill, MD | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14522812 | Background | McFadden ER Jr. Acute severe asthma. Am J Respir Crit Care Med. 2003 Oct 1;168(7):740-59. doi: 10.1164/rccm.200208-902SO. | |
| 17983880 | Background | National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Small Volume Jet Nebulizer | Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol. The bronchodilators will be administered via small volume jet nebulizer |
| FG001 | Aeroneb Nebulizer | Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol. The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation. The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Small Volume Jet Nebulizer | Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol. The bronchodilators will be administered via small volume jet nebulizer |
| BG001 | Aeroneb Nebulizer |
| 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 | Percentage Change in Mean of Peak Expiratory Flow Rate (PEFR) Percentage of Predicted Baseline at 30 Minutes After the Initial Bronchodilator Treatment | Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration. | Posted | Mean | Standard Deviation | percent change | 30 minutes |
|
Adverse events data was collected for 2 years, the duration of the study.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Small Volume Jet Nebulizer | Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol. The bronchodilators will be administered via small volume jet nebulizer |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicholas S. Hill | Tufts Medical Center | 617-636-0688 | nhill@tuftsmedicalcenter.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2016 | Apr 11, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Small volume jet nebulizer | Device | The bronchodilators will be administered via small volume jet nebulizer |
|
Forced expiratory volume refers to the volume of air that an individual can exhale during a forced breath in 1 second. |
| initial bronchodilator treatment to disposition, an average of 4 hours |
| Change in the Borg-Dyspnea Score From Baseline to Disposition | The Borg-Dyspnea score measures an individual's effort, exertion, breathlessness and fatigue during physical work. This scale ranges from 6-20 with 6 representing no exertion at all and 20 representing maximal exertion. | initial bronchodilator treatment to disposition, an average of 4 hours |
| Change in Heart Rate Baseline to Disposition | Change in the heart rate at baseline after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group. | The initial bronchodilator treatment to to disposition, an average of 4 hours |
| Length of Stay in the ER | Total length from admission to discharge. | Length of stay in the ER - up to one day |
| Percentage of Patients Requiring Hospitalization | Total amount of patients requiring hospitalization after ER admission. | Length of stay in the ER - up to one day |
| The Total Dose of Albuterol Used in Each Group During ED Stay | Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease. | Length of stay in the ER - up to one day |
| 9002561 | Background | Rodrigo G, Rodrigo C. A new index for early prediction of hospitalization in patients with acute asthma. Am J Emerg Med. 1997 Jan;15(1):8-13. doi: 10.1016/s0735-6757(97)90039-5. |
| 9792570 | Background | Rodrigo G, Rodrigo C. Early prediction of poor response in acute asthma patients in the emergency department. Chest. 1998 Oct;114(4):1016-21. doi: 10.1378/chest.114.4.1016. |
| 17273562 | Background | Piovesan DM, Menegotto DM, Kang S, Franciscatto E, Millan T, Hoffmann C, Pasin LR, Fischer J, Barreto SS, Dalcin Pde T. Early prognosis of acute asthma in the emergency room. J Bras Pneumol. 2006 Jan-Feb;32(1):1-9. doi: 10.1590/s1806-37132006000100004. English, Portuguese. |
| 20587095 | Background | Ari A, Atalay OT, Harwood R, Sheard MM, Aljamhan EA, Fink JB. Influence of nebulizer type, position, and bias flow on aerosol drug delivery in simulated pediatric and adult lung models during mechanical ventilation. Respir Care. 2010 Jul;55(7):845-51. |
| 26106207 | Background | Galindo-Filho VC, Ramos ME, Rattes CS, Barbosa AK, Brandao DC, Brandao SC, Fink JB, de Andrade AD. Radioaerosol Pulmonary Deposition Using Mesh and Jet Nebulizers During Noninvasive Ventilation in Healthy Subjects. Respir Care. 2015 Sep;60(9):1238-46. doi: 10.4187/respcare.03667. Epub 2015 Jun 23. |
| 1735247 | Background | Alvine GF, Rodgers P, Fitzsimmons KM, Ahrens RC. Disposable jet nebulizers. How reliable are they? Chest. 1992 Feb;101(2):316-9. doi: 10.1378/chest.101.2.316. |
| 5523831 | Background | Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2(2):92-8. No abstract available. |
| 8630538 | Background | Patrick W, Webster K, Ludwig L, Roberts D, Wiebe P, Younes M. Noninvasive positive-pressure ventilation in acute respiratory distress without prior chronic respiratory failure. Am J Respir Crit Care Med. 1996 Mar;153(3):1005-11. doi: 10.1164/ajrccm.153.3.8630538. |
Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol. The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation. The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Secondary | Percentage Change in the PEFR Percentage of Predicted Baseline to Disposition | Change in the PEFR percent predicted from the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group. | Posted | Mean | Standard Deviation | percent change | Initial bronchodilator treatment to disposition, an average of 4 hours |
|
|
|
| Secondary | Percentage Change in the Forced Expiratory Volume (FEV1) Percentage of Predicted Baseline to Disposition | Forced expiratory volume refers to the volume of air that an individual can exhale during a forced breath in 1 second. | Posted | Mean | Standard Deviation | percent change | initial bronchodilator treatment to disposition, an average of 4 hours |
|
|
|
| Secondary | Change in the Borg-Dyspnea Score From Baseline to Disposition | The Borg-Dyspnea score measures an individual's effort, exertion, breathlessness and fatigue during physical work. This scale ranges from 6-20 with 6 representing no exertion at all and 20 representing maximal exertion. | Posted | Mean | Standard Deviation | score on a scale | initial bronchodilator treatment to disposition, an average of 4 hours |
|
|
|
| Secondary | Change in Heart Rate Baseline to Disposition | Change in the heart rate at baseline after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group. | Posted | Mean | Standard Deviation | Change in heart rate (beats/min) | The initial bronchodilator treatment to to disposition, an average of 4 hours |
|
|
|
| Secondary | Length of Stay in the ER | Total length from admission to discharge. | Posted | Mean | Standard Deviation | minutes | Length of stay in the ER - up to one day |
|
|
|
| Secondary | Percentage of Patients Requiring Hospitalization | Total amount of patients requiring hospitalization after ER admission. | Posted | Count of Participants | Participants | Length of stay in the ER - up to one day |
|
|
|
| Secondary | The Total Dose of Albuterol Used in Each Group During ED Stay | Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease. | Posted | Mean | Standard Deviation | dosage (mg) | Length of stay in the ER - up to one day |
|
|
|
| Other Pre-specified | The Total Dose of Ipratropium Used in Each Group During ED Stay | Ipratropium is used to prevent wheezing, shortness of breath, coughing and chest tightness in people with chronic obstructive pulmonary disease, chronic bronchitis, and emphysema. It is a bronchodilator which relaxes and opens the air passages to the lungs to make breathing easier. | Posted | Mean | Standard Deviation | dosage (mg) | Length of stay in the ER - up to one day |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Aeroneb Nebulizer | Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol. The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation. The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium). | 0 | 16 | 0 | 16 | 0 | 16 |
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |