Budesonide Inhalation Suspension for Acute Asthma in Children

NCT00393367 | Completed Phase 4 Results

• 1 other identifier: 2006-8-4875
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma; Acute Asthma; Reactive Airway Exacerbation

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; Budesonide admixture; Albuterol; Continuous albuterol; Ipratropium bromide

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (10)

• Number of Patients Hospitalized

  within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo

• Change in Mean Heart Rate

  From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

• Mean Change in Respiratory Rate.

  Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator

• Oxygen Saturation.

  2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator

• Number of Subjects Remaining in the Severe Asthma Category

  From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

Study Arms (2)

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.

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.

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

Interventions

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.

Also known as: Pulmicort, Albuterol

Budesonide Inhalaiton Suspension

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.

Also known as: Prednisolone, prednisone, methylprednisolone

Budesonide Inhalaiton Suspension; Saline Placebo

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.

Also known as: Albuterol, Atrovent

Budesonide Inhalaiton Suspension; Saline Placebo

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.

Also known as: Atrovent

Budesonide Inhalaiton Suspension; Saline Placebo

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Systemic corticosteroid prescribed in the Emergency Department
• English-speaking parent/guardian present
• Parental/guardian permission (informed consent) and if appropriate, child assent

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia Emergency Department

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (7)

• 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.

  PMID: 12917930 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.

  PMID: 9761804 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.

  PMID: 9523927 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.

  PMID: 10503681 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.

  PMID: 7574132 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.

  PMID: 16261956 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.

  PMID: 10974132 BACKGROUND

MeSH Terms

Conditions

Asthma; Emergencies

Interventions

Albuterol; Budesonide; Prednisolone; Prednisone; Methylprednisolone; Ipratropium

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnadienediols; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Cynthia J. Mollen
• Organization: The Children's Hospital of Philadelphia

mollenc@email.chop.edu

215-590-4410

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2006
• First Posted: October 27, 2006
• Study Start: December 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: August 10, 2012
• Results First Posted: July 25, 2011

Record last verified: 2012-08

Locations

US (1)