Steroids Helping Albuterol Responders Exclusively

NCT00798616 | Withdrawn

• 1 other identifier: UHC 07-08-36
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bronchiolitis

Keywords

bronchiolitis; steroids; corticosteroids; albuterol; child; infant; pediatric

Outcome Measures

Primary Outcomes (2)

• respiratory rate and respiratory distress score

  4 hours

• length of hospitalization (actual and until meets "ready for discharge" criteria)

  variable, likely no more than 2 weeks

Secondary Outcomes (6)

• need for increased respiratory support (intubation, CPAP, BiPAP)

  variable, likely up to 2 weeks

• amount of oxygen used during hospitalization

  variable, likely less than 2 weeks

• number of doses of bronchodilators used during hospitalization

  variable, likely no more than 2 weeks

• total duration of symptoms

  variable, likely no more than 3 weeks

• need for unanticipated medical care after discharge

  variable, likely no more than 3 weeks

Study Arms (4)

Responders/Placebo

PLACEBO COMPARATOR

Albuterol responders being given placebo

Drug: placebo

Responders/Steroids

ACTIVE COMPARATOR

albuterol responders being given steroids

Drug: prednisolone or methylprednisolone

Non-responders/placebo

PLACEBO COMPARATOR

non-albuterol responders being given placebo

Drug: placebo

non-responders/steroids

ACTIVE COMPARATOR

non-albuterol responders being given steroids

Drug: prednisolone or methylprednisolone

Interventions

prednisolone or methylprednisolone DRUG

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

Also known as: corticosteroids, Solu-Medrol, Orapred

Responders/Steroids; non-responders/steroids

placebo DRUG

oral or IV placebo

Non-responders/placebo; Responders/Placebo

Eligibility Criteria

• Age: 4 Weeks - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Publications (19)

• American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93. doi: 10.1542/peds.2006-2223.

  PMID: 17015575 BACKGROUND

• 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. doi: 10.1001/jama.282.15.1440.

  PMID: 10535434 BACKGROUND

• 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. doi: 10.1001/archpedi.155.1.95. No abstract available.

  PMID: 11177073 BACKGROUND

• 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. doi: 10.1016/s0022-3476(96)70071-9.

  PMID: 8804328 BACKGROUND

• 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. doi: 10.1097/00006565-199208000-00003.

  PMID: 1513726 BACKGROUND

• Kristjansson S, Lodrup Carlsen KC, Wennergren G, Strannegard 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. doi: 10.1136/adc.69.6.650.

  PMID: 8285776 BACKGROUND

• Gadomski AM, Bhasale AL. Bronchodilators for bronchiolitis. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD001266. doi: 10.1002/14651858.CD001266.pub2.

  PMID: 16855963 BACKGROUND

• 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. doi: 10.1542/peds.101.3.361.

  PMID: 9480998 BACKGROUND

• 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. doi: 10.1002/14651858.CD004878.

  PMID: 15266547 BACKGROUND

• Garrison MM, Christakis DA, Harvey E, Cummings P, Davis RL. Systemic corticosteroids in infant bronchiolitis: A meta-analysis. Pediatrics. 2000 Apr;105(4):E44. doi: 10.1542/peds.105.4.e44.

  PMID: 10742365 BACKGROUND

• 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. doi: 10.1016/j.jpeds.2007.04.010. Epub 2007 Jun 29.

  PMID: 17719935 BACKGROUND

• 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. doi: 10.1067/s0022-3476(03)00510-9.

  PMID: 14615711 BACKGROUND

• 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. doi: 10.1542/peds.100.6.937.

  PMID: 9374560 BACKGROUND

• 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. doi: 10.1001/archpedi.157.10.957.

  PMID: 14557155 BACKGROUND

• 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. doi: 10.1056/NEJMoa022226.

  PMID: 12840089 BACKGROUND

• 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.

  PMID: 2201941 BACKGROUND

• 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. doi: 10.1136/adc.70.3.170.

  PMID: 8135557 BACKGROUND

• Smith M, Iqbal S, Elliott TM, Everard M, Rowe BH. Corticosteroids for hospitalised children with acute asthma. Cochrane Database Syst Rev. 2003;2003(2):CD002886. doi: 10.1002/14651858.CD002886.

  PMID: 12804441 BACKGROUND

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  PMID: 9113963 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis

Interventions

Prednisolone; Methylprednisolone; Adrenal Cortex Hormones; Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Steven L Shein, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Last Updated: December 9, 2014

Record last verified: 2010-10

Locations

US (1)