Steroids Helping Albuterol Responders Exclusively

Bronchiolitis Clinical Trial

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Official title:

Are Steroids Efficacious in Hospitalized Patients With Bronchiolitis Who Show an Objective Clinical Improvement After Albuterol ("Albuterol Responders")?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00798616
• Other study ID #: UHC 07-08-36
• Status: Withdrawn
• Phase: N/A
• First received: November 25, 2008
• Last updated: December 5, 2014

Study information

• Verified date: October 2010
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

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
• placebo
oral or IV placebo

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Case Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Gadomski AM, Bhasale AL. Bronchodilators for bronchiolitis. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD001266. Review. Update in: Cochrane Database Syst Rev. 2010;(12):CD001266. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	respiratory rate and respiratory distress score		4 hours	No
Primary	length of hospitalization (actual and until meets "ready for discharge" criteria)		variable, likely no more than 2 weeks	No
Secondary	need for increased respiratory support (intubation, CPAP, BiPAP)		variable, likely up to 2 weeks	Yes
Secondary	amount of oxygen used during hospitalization		variable, likely less than 2 weeks	No
Secondary	number of doses of bronchodilators used during hospitalization		variable, likely no more than 2 weeks	No
Secondary	total duration of symptoms		variable, likely no more than 3 weeks	No
Secondary	need for unanticipated medical care after discharge		variable, likely no more than 3 weeks	No
Secondary	tachycardia and/or hypertension during hospitalization		variable, likely no more than 2 weeks	Yes