Bronchiolitis All-study, SE-Norway

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Oslo
Ostfold University College, Fredrikstad, Norway
Vestre Viken Hospital Trust
Sykehuset i Vestfold HF
Sykehuset Telemark
Sorlandet Hospital HF
Sykehuset Innlandet HF
Haukeland University Hospital
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00817466
First received: January 5, 2009
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

Bronchiolitis is a common lower respiratory disease typically affecting infants and children generally younger than 2 years of age. The disease leads to hospital admissions, is a major cause for hospitalisation of young children and infants during winter epidemics, may be severe sometimes requiring ventilatory support and rarely death. The clinical disease as described by Court is characterised by nasal flaring, tachypnoea, dyspnoea, chest recessions, crepitations and sometimes sibiliations. Respiratory Syncytial virus is the most common cause, but also other respiratory vira may cause the disease. Bronchiolitis is a well known risk factor of asthma development in childhood1,2.

Management is generally supportive, whereas symptom reducing therapy is debated with no international consensus. Furthermore, there are many unresolved questions related to the prognosis of bronchiolitis, its role in development of chronic lung disease in particular regarding the association between early bronchiolitis and asthma development. The present project will particularly focus on: 1)Treatment efficacy related to various outcomes during active disease, 2) retrospectively assess treatment efficacy in relation to later development of allergic disease, 3) assess the role between different vira and asthma prognosis as well as 4) identify possible prognostic factors involved in the progression from bronchiolitis to further airways disease.


Condition Intervention Phase
Bronchiolitis
Drug: Racemic adrenaline
Drug: Isotonic saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Bronchiolitis All-study, SE-Norway What is the Optimal Inhalation Treatment for Children 0-12 Months With Acute Bronchiolitis?

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • No of hours before deemed fit for discharge from hospital [ Time Frame: Throughout the hospital stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical status (by parents as well as nurses) every 12 hrs [ Time Frame: prior to inhalation every morning and evening ] [ Designated as safety issue: No ]
  • Need for feeding support (no. of hours) [ Time Frame: Throughout the hospital stay. ] [ Designated as safety issue: No ]
  • Need for supplementary oxygen. [ Time Frame: Throughout the hospital stay. ] [ Designated as safety issue: Yes ]
  • Clinical score measured by doctor [ Time Frame: Throughout the hospital stay. Daily before and 30min after inhalation in daytime. ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Racemic adrenaline, fixed intervals
Active drug with fixed intervals of inhalation, adjusted at least every 24h.
Drug: Racemic adrenaline

For inhalation.

Dosing (as in previous study):

1) 0,1ml<5kg, 0,15ml 5-6,9kg, 0,20ml 7-9,9kg, 0,25ml >10kg of racemic adrenaline 20mg/ml diluted in 2ml NaCl 9mg/ml.3

Maximum 12 inhalations/24 hours. One bottle (10ml) per patient. The bottles will be marked with the name of the study and a randomisation number.

Other Name: Racemic adrenaline, racemic epinephrine, S2, vaponefrin, micronefrin
Experimental: Racemic adrenalin, on demand
Racemic adrenaline, inhalations on demand (max every 2 hrs)
Drug: Racemic adrenaline

For inhalation.

Dosing (as in previous study):

1) 0,1ml<5kg, 0,15ml 5-6,9kg, 0,20ml 7-9,9kg, 0,25ml >10kg of racemic adrenaline 20mg/ml diluted in 2ml NaCl 9mg/ml.3

Maximum 12 inhalations/24 hours. One bottle (10ml) per patient. The bottles will be marked with the name of the study and a randomisation number.

Other Name: Racemic adrenaline, racemic epinephrine, S2, vaponefrin, micronefrin
Active Comparator: Saline, fixed intervals
Saline inhalation fixed intervals, adjusted at least every 24 hrs
Drug: Isotonic saline
2ml NaCl 9mg/ml.
Other Name: Isotonic saline. NaCl 0,9%. NaCl 9mg/ml.
Active Comparator: saline on demand
Saline inhalations on demand, max every 2 hrs, adjusted every 12 hrs
Drug: Isotonic saline
2ml NaCl 9mg/ml.
Other Name: Isotonic saline. NaCl 0,9%. NaCl 9mg/ml.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 11 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children 0 inclusive 11 months admitted to the hospital with symptoms and signs of acute bronchiolitis during the winter season of 2009-11.
  • bronchiolitis as defined on clinical criteria by SDM Court (Post graduate medical journal 1973).
  • Clinical score of 4 or more (Kristjansson, Arch.Dis.Child. 1993)

Exclusion criteria:

  • Use of regular inhaled corticosteroids.
  • Use of systemic or inhaled corticosteroids within the last 4 weeks.
  • Significant cardiac, previous severe or persisting (>4 weeks) respiratory disease, neurologic, immunologic, oncologic or other disease that may significantly influence the outcomes, including Down's syndrome. Prematurity per se is not a reason for exclusion.
  • One single previous mild-moderate episode suspect of bronchial obstruction is not an exclusion criterion, >1 are.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817466

Locations
Norway
Sykehuset Buskerud, Vestre Viken
Drammen, Buskerud, Norway, N-3004
Sykehuset Innlandet, Elverum
Elverum, Hedmark, Norway, NO-2409
Sykehuset Innlandet, Lillehammer
Lillehammer, Oppland, Norway, N-2609
Sykehuset Telemark, Skien
Skien, Telemark, Norway, N-3710
Sørlandet sykehus HF, Kristiansand
Kristiansand, Vest-Agder, Norway, N-4604
Sykehuset Vestfold, Tønsberg
Tønsberg, Vestfold, Norway, N-3103
Ullevaal University Hospital, department of Paediatrics
Oslo, Norway, NO-0407
Oslo University Hospital, Rikshospitalet
Oslo, Norway, N-0027
Sykehuset Østfold, Fredrikstad
Fredrikstad, Østfold, Norway, N-1603
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Ostfold University College, Fredrikstad, Norway
Vestre Viken Hospital Trust
Sykehuset i Vestfold HF
Sykehuset Telemark
Sorlandet Hospital HF
Sykehuset Innlandet HF
Haukeland University Hospital
Investigators
Study Director: Karin C. Lødrup Carlsen, MD,pHD Ullevål University Hospital HF
Principal Investigator: Håvard O Skjerven, MD Ullevål University Hospital HF
  More Information

Additional Information:
No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00817466     History of Changes
Other Study ID Numbers: EudraCT 2009-012667-34
Study First Received: January 5, 2009
Last Updated: November 1, 2012
Health Authority: Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
bronchiolitis
infants
racemic adrenaline
inhalations
treatment

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 22, 2014