Steroids Helping Albuterol Responders Exclusively - Full Text View

Sponsored by:	University Hospitals of Cleveland
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00798616

Purpose

The purpose of the study is to determine whether corticosteroids are beneficial to children with bronchiolitis whose breathing gets better after being given a breathing treatment with albuterol.

Condition	Intervention
Bronchiolitis	Drug: prednisolone or methylprednisolone Drug: placebo

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Corticosteroids Albuterol sulfate Albuterol Levalbuterol hydrochloride Levalbuterol tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Are Steroids Efficacious in Hospitalized Patients With Bronchiolitis Who Show an Objective Clinical Improvement After Albuterol ("Albuterol Responders")?

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:

respiratory rate and respiratory distress score [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
length of hospitalization (actual and until meets "ready for discharge" criteria) [ Time Frame: variable, likely no more than 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

need for increased respiratory support (intubation, CPAP, BiPAP) [ Time Frame: variable, likely up to 2 weeks ] [ Designated as safety issue: Yes ]
amount of oxygen used during hospitalization [ Time Frame: variable, likely less than 2 weeks ] [ Designated as safety issue: No ]
number of doses of bronchodilators used during hospitalization [ Time Frame: variable, likely no more than 2 weeks ] [ Designated as safety issue: No ]
total duration of symptoms [ Time Frame: variable, likely no more than 3 weeks ] [ Designated as safety issue: No ]
need for unanticipated medical care after discharge [ Time Frame: variable, likely no more than 3 weeks ] [ Designated as safety issue: No ]
tachycardia and/or hypertension during hospitalization [ Time Frame: variable, likely no more than 2 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	December 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Responders/Placebo: Placebo Comparator Albuterol responders being given placebo	Drug: placebo oral or IV placebo
Responders/Steroids: Active Comparator albuterol responders being given steroids	Drug: prednisolone or methylprednisolone either prednisolone 2mg/kg PO once daily or methylprednisolone 1.6mg/kg IV once daily (if IV access is present) for length of hospitalization, for a maximum of seven days
Non-responders/placebo: Placebo Comparator non-albuterol responders being given placebo	Drug: placebo oral or IV placebo
non-responders/steroids: Active Comparator non-albuterol responders being given steroids	Drug: prednisolone or methylprednisolone either prednisolone 2mg/kg PO once daily or methylprednisolone 1.6mg/kg IV once daily (if IV access is present) for length of hospitalization, for a maximum of seven days

Eligibility

Ages Eligible for Study:	up to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosis of bronchiolitis
Respiratory Distress Assessment Index score of 4 or more

Exclusion Criteria:

prior prescription of bronchodilators or inhaled corticosteroids
birth at <36 weeks gestation
chronic cardiac disease
chronic pulmonary disease (including asthma)
immunodeficiency
non-topical steroid use in the prior week
parents that don't understand English
baseline systolic blood pressure >118 mmHg
home oxygen use
evidence of systemic fungal or varicella infection
bronchodilator use in the prior week
allergy to albuterol or corticosteroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798616

Contacts

Contact: Steven L Shein, MD	216-844-1117	drstevenshein@gmail.com
Contact: Ethan Leonard, MD	216-844-8735	ethan.leonard@uhhs.com

Locations

United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

University Hospitals of Cleveland

Investigators

Principal Investigator:

Steven L Shein, MD

University Hospitals of Cleveland

More Information

Publications:

American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93.

Shay DK, Holman RC, Newman RD, Liu LL, Stout JW, Anderson LJ. Bronchiolitis-associated hospitalizations among US children, 1980-1996. JAMA. 1999 Oct 20;282(15):1440-6.

Stang P, Brandenburg N, Carter B. The economic burden of respiratory syncytial virus-associated bronchiolitis hospitalizations. Arch Pediatr Adolesc Med. 2001 Jan;155(1):95-6. No abstract available.

Wang EE, Law BJ, Boucher FD, Stephens D, Robinson JL, Dobson S, Langley JM, McDonald J, MacDonald NE, Mitchell I. Pediatric Investigators Collaborative Network on Infections in Canada (PICNIC) study of admission and management variation in patients hospitalized with respiratory syncytial viral lower respiratory tract infection. J Pediatr. 1996 Sep;129(3):390-5.

Schweich PJ, Hurt TL, Walkley EI, Mullen N, Archibald LF. The use of nebulized albuterol in wheezing infants. Pediatr Emerg Care. 1992 Aug;8(4):184-8.

Kristjánsson S, Lødrup Carlsen KC, Wennergren G, Strannegård IL, Carlsen KH. Nebulised racemic adrenaline in the treatment of acute bronchiolitis in infants and toddlers. Arch Dis Child. 1993 Dec;69(6):650-4.

Gadomski AM, Bhasale AL. Bronchodilators for bronchiolitis. Cochrane Database Syst Rev. 2006 Jul 19;3:CD001266. Review.

Dobson JV, Stephens-Groff SM, McMahon SR, Stemmler MM, Brallier SL, Bay C. The use of albuterol in hospitalized infants with bronchiolitis. Pediatrics. 1998 Mar;101(3 Pt 1):361-8.

Patel H, Platt R, Lozano JM, Wang EE. Glucocorticoids for acute viral bronchiolitis in infants and young children. Cochrane Database Syst Rev. 2004;(3):CD004878. Review. Update in: Cochrane Database Syst Rev. 2008;(1):CD004878.

Garrison MM, Christakis DA, Harvey E, Cummings P, Davis RL. Systemic corticosteroids in infant bronchiolitis: A meta-analysis. Pediatrics. 2000 Apr;105(4):E44.

Kuzik BA, Al-Qadhi SA, Kent S, Flavin MP, Hopman W, Hotte S, Gander S. Nebulized hypertonic saline in the treatment of viral bronchiolitis in infants. J Pediatr. 2007 Sep;151(3):266-70, 270.e1. Epub 2007 Jun 29.

Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr. 2003 Nov;143(5 Suppl):S127-32.

Rodriguez WJ, Gruber WC, Groothuis JR, Simoes EA, Rosas AJ, Lepow M, Kramer A, Hemming V. Respiratory syncytial virus immune globulin treatment of RSV lower respiratory tract infection in previously healthy children. Pediatrics. 1997 Dec;100(6):937-42.

Hartling L, Wiebe N, Russell K, Patel H, Klassen TP. A meta-analysis of randomized controlled trials evaluating the efficacy of epinephrine for the treatment of acute viral bronchiolitis. Arch Pediatr Adolesc Med. 2003 Oct;157(10):957-64. Review.

Wainwright C, Altamirano L, Cheney M, Cheney J, Barber S, Price D, Moloney S, Kimberley A, Woolfield N, Cadzow S, Fiumara F, Wilson P, Mego S, VandeVelde D, Sanders S, O'Rourke P, Francis P. A multicenter, randomized, double-blind, controlled trial of nebulized epinephrine in infants with acute bronchiolitis. N Engl J Med. 2003 Jul 3;349(1):27-35.

Tal A, Levy N, Bearman JE. Methylprednisolone therapy for acute asthma in infants and toddlers: a controlled clinical trial. Pediatrics. 1990 Sep;86(3):350-6.

Connett GJ, Warde C, Wooler E, Lenney W. Prednisolone and salbutamol in the hospital treatment of acute asthma. Arch Dis Child. 1994 Mar;70(3):170-3.

Smith M, Iqbal S, Elliott TM, Everard M, Rowe BH. Corticosteroids for hospitalised children with acute asthma. Cochrane Database Syst Rev. 2003;(2):CD002886. Review.

Gorelick MH, Shaw KN, Murphy KO. Validity and reliability of clinical signs in the diagnosis of dehydration in children. Pediatrics. 1997 May;99(5):E6.

Responsible Party:	University Hospitals of Cleveland ( Steven Shein, Chief Resident, Department of Pediatrics )
Study ID Numbers:	UHC 07-08-36
Study First Received:	November 25, 2008
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00798616
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:

bronchiolitis
steroids
corticosteroids
albuterol

child
infant
pediatric

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Methylprednisolone
Lung Diseases
Bronchiolitis

Albuterol
Prednisolone
Methylprednisolone acetate
Prednisolone acetate
Bronchitis
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Neuroprotective Agents
Hormones
Adrenergic Agonists

Tocolytic Agents
Therapeutic Uses
Adrenergic beta-Agonists
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Anti-Asthmatic Agents
Protective Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009