AsthmaPhase 4NCT00393367
Budesonide Inhalation Suspension for Acute Asthma in Children
A Phase 4 study testing Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg, Prednisolone, prednisone, or methylprednisolone and Albuterol, ipratropium bromide in people with Asthma and Acute Asthma, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Asthma, Acute Asthma, Reactive Airway Exacerbation
- What is being tested?
- Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg, Prednisolone, prednisone, or methylprednisolone and Albuterol, ipratropium bromide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Nov 2007
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Chief complaint of "respiratory distress", "asthma", "trouble breathing", or "reactive airway disease"
- Males or females age 2 to 18 years
- Weight greater than or equal to 10 kilograms
- Two or more prior Emergency Department or primary care visits for asthma or reactive airway disease
- Identified in triage as either "acute" or "critical"
- Asthma score of 8 or greater
Show all 9Show fewer
- Systemic corticosteroid prescribed in the Emergency Department
- English-speaking parent/guardian present
- Parental/guardian permission (informed consent) and if appropriate, child assent
Who cannot join
- Systemic corticosteroid use in the last 30 days
- Chronic lung diseases including cystic fibrosis
- Sickle cell anemia
- Immunodeficiency
- Cardiac disease requiring surgery or medications
- Adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone
Show all 12Show fewer
- Known renal or hepatic dysfunction
- Exposure to varicella in the last 21 days
- Impending respiratory failure requiring positive pressure ventilation
- Altered level of consciousness
- Suspected foreign body aspiration or croup
- Prior enrollment in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia Emergency Department
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the detailed description
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.
- Conditions
- Asthma, Acute Asthma, Reactive Airway Exacerbation
- Being tested
- Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg, Prednisolone, prednisone, or methylprednisolone, Albuterol, ipratropium bromide, Ipratropium bromide
- Keywords
- Asthma, Acute, Treatment, Children, Pediatric, Inhaled corticosteroid, Budesonide, Budesonide inhalation suspension, Asthma score, Emergency, Emergency Department, Asthma flare, Clinical trial, Randomized clinical trial, Randomized trial, Pulmonary index score, Hospitalization, Moderate asthma, Severe asthma, Mixing budesonide
- Medical subject headings
- Asthma, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mgDrug
Also called Pulmicort, Albuterol
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.
Prednisolone, prednisone, or methylprednisoloneDrug
Also called Prednisolone, prednisone, methylprednisolone
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.
Albuterol, ipratropium bromideDrug
Also called Albuterol, Atrovent
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.
Ipratropium bromideDrug
Also called Atrovent
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Prednisolone, prednisone, or methylprednisolone; Drug: Albuterol, ipratropium bromide; Drug: Ipratropium bromide |
| 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. Receives: Drug: Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg; Drug: Prednisolone, prednisone, or methylprednisolone; Drug: Albuterol, ipratropium bromide; Drug: Ipratropium bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator
Secondary outcomes (10)
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.
Measured: within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: within 5 days of ED visit
Number of Participants With Adverse Events (Non-serious).
Measured: within 30 days of the ED visit
Serious Adverse Events
Serious Adverse Events
Measured: 0-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2006 (estimated)
- Study startDec 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia J Mollen, M.D., Principal investigator, Children's Hospital of PhiladelphiaBryan D. Upham, M.D., Study director, University of New Mexico Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393367
- Sponsor's protocol ID
- 2006-8-4875
- Status last verified
- Aug 2012
- First submitted
- 25 Oct 2006
- Last updated
- 10 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 12917930Qureshi 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.
PubMed 9761804Sung 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.
PubMed 9523927Devidayal, 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.
PubMed 10503681Scarfone 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.
PubMed 7574132Nuhoglu 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.
PubMed 16261956Schuh 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.
PubMed 10974132
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Budesonide Inhalation Suspension for Acute Asthma in Children
- ClinicalTrials.gov ID
- NCT00393367
- Acronym / sponsor ID
- 2006-8-4875
- Conditions
- Asthma, Acute Asthma, Reactive Airway Exacerbation
- Keywords
- Asthma, Acute, Treatment, Children, Pediatric, Inhaled corticosteroid, Budesonide, Budesonide inhalation suspension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 27 Oct 2006 (estimated)
- Results
- Posted 25 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline Placebo | Placebo comparator | Drug: Prednisolone, prednisone, or methylprednisolone, Drug: Albuterol, ipratropium bromide, Drug: Ipratropium bromideAll 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. |
| Budesonide Inhalaiton Suspension | Experimental | Drug: Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg, Drug: Prednisolone, prednisone, or methylprednisolone, Drug: Albuterol, ipratropium bromide, Drug: Ipratropium bromideAll 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Chief complaint of "respiratory distress", "asthma", "trouble breathing", or "reactive airway disease"
- Males or females age 2 to 18 years
- Weight greater than or equal to 10 kilograms
- Two or more prior Emergency Department or primary care visits for asthma or reactive airway disease
- Identified in triage as either "acute" or "critical"
Key exclusion criteria (12 listed)
- Systemic corticosteroid use in the last 30 days
- Chronic lung diseases including cystic fibrosis
- Sickle cell anemia
- Immunodeficiency
- Cardiac disease requiring surgery or medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mgAlso: Pulmicort, AlbuterolPatients 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. | Drug | Budesonide Inhalaiton Suspension |
| Prednisolone, prednisone, or methylprednisoloneAlso: Prednisolone, prednisone, methylprednisoloneAll 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. | Drug | Budesonide Inhalaiton Suspension, Saline Placebo |
| Albuterol, ipratropium bromideAlso: Albuterol, AtroventWhile 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. | Drug | Budesonide Inhalaiton Suspension, Saline Placebo |
| Ipratropium bromideAlso: Atrovent500 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. | Drug | Budesonide Inhalaiton Suspension, Saline Placebo |
Primary outcome
Median Change in Asthma Score 2 Hours After Intervention
Time frame: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator
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.
Mean Change in Asthma Score at 2 Hours
Time frame: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator
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.
10 secondary outcomes
Number of Patients Hospitalized
Time frame: within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo
Change in Mean Heart Rate
Time frame: From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator
Mean Change in Respiratory Rate.
Time frame: Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator
Oxygen Saturation.
Time frame: 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator
Number of Subjects Remaining in the Severe Asthma Category
Time frame: 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
Time frame: 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
Time frame: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator
Relapse / Readmission Numbers.
Time frame: within 5 days of ED visit
Number of Participants With Adverse Events (Non-serious).
Time frame: within 30 days of the ED visit
Serious Adverse Events
Time frame: 0-5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12917930Edmonds 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.
- Background: PubMed 9761804Qureshi 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.
- Background: PubMed 9523927Sung 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.
- Background: PubMed 10503681Devidayal, 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.
- Background: PubMed 7574132Scarfone 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.
- Background: PubMed 16261956Nuhoglu 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.
- Background: PubMed 10974132Schuh 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia J Mollen, M.D. principal investigator
Children's Hospital of Philadelphia
Bryan D. Upham, M.D. study director
University of New Mexico Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg, Prednisolone, prednisone, or methylprednisolone and Albuterol, ipratropium bromide in people with Asthma and Acute Asthma, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Change in Asthma Score 2 Hours After Intervention (time frame: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00393367, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2012.