Bronchiolitis All-study, SE-Norway

NCT00817466 | Unknown Phase 4 DMC

• 1 other identifier: EudraCT 2009-012667-34
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Bronchiolitis

Keywords

bronchiolitis; infants; racemic adrenaline; inhalations; treatment

Outcome Measures

Primary Outcomes (1)

• No of hours before deemed fit for discharge from hospital

  Throughout the hospital stay

Secondary Outcomes (4)

• Clinical status (by parents as well as nurses) every 12 hrs

  prior to inhalation every morning and evening

• Need for feeding support (no. of hours)

  Throughout the hospital stay.

• Need for supplementary oxygen.

  Throughout the hospital stay.

• Clinical score measured by doctor

  Throughout the hospital stay. Daily before and 30min after inhalation in daytime.

Study Arms (4)

Racemic adrenaline, fixed intervals

EXPERIMENTAL

Active drug with fixed intervals of inhalation, adjusted at least every 24h.

Drug: Racemic adrenaline

Racemic adrenalin, on demand

EXPERIMENTAL

Racemic adrenaline, inhalations on demand (max every 2 hrs)

Drug: Racemic adrenaline

Saline, fixed intervals

ACTIVE COMPARATOR

Saline inhalation fixed intervals, adjusted at least every 24 hrs

Drug: Isotonic saline

saline on demand

ACTIVE COMPARATOR

Saline inhalations on demand, max every 2 hrs, adjusted every 12 hrs

Drug: Isotonic saline

Interventions

Racemic adrenaline DRUG

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.

Also known as: Racemic adrenaline, racemic epinephrine, S2, vaponefrin, micronefrin

Racemic adrenalin, on demand; Racemic adrenaline, fixed intervals

Isotonic saline DRUG

2ml NaCl 9mg/ml.

Also known as: Isotonic saline. NaCl 0,9%. NaCl 9mg/ml.

Saline, fixed intervals; saline on demand

Eligibility Criteria

• Age: Up to 11 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Use of regular inhaled corticosteroids.
• Use of systemic or inhaled corticosteroids within the last 4 weeks.

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator
• Ostfold University College: collaborator
• Vestre Viken Hospital Trust: collaborator
• Sykehuset i Vestfold HF: collaborator
• Sykehuset Telemark: collaborator
• Sorlandet Hospital HF: collaborator
• Sykehuset Innlandet HF: collaborator
• Haukeland University Hospital: collaborator

Study Sites (9)

Sykehuset Buskerud, Vestre Viken

Drammen, Buskerud, N-3004, Norway

Location

Sykehuset Innlandet, Elverum

Elverum, Hedmark, NO-2409, Norway

Location

Sykehuset Innlandet, Lillehammer

Lillehammer, Oppland, N-2609, Norway

Location

Oslo University Hospital, Rikshospitalet

Oslo, Oslo County, N-0027, Norway

Location

Sykehuset Telemark, Skien

Skien, Telemark, N-3710, Norway

Location

Sørlandet sykehus HF, Kristiansand

Kristiansand, Vest-Agder, N-4604, Norway

Location

Sykehuset Vestfold, Tønsberg

Tønsberg, Vestfold, N-3103, Norway

Location

Ullevaal University Hospital, department of Paediatrics

Oslo, NO-0407, Norway

Location

Sykehuset Østfold, Fredrikstad

Fredrikstad, Østfold fylke, N-1603, Norway

Location

Related Publications (7)

• Skjerven HO, Hunderi JOG, Carlsen KH, Rolfsjord LB, Nordhagen L, Berents TL, Bains KES, Buchmann M, Carlsen KCL. Allergic sensitisation in infants younger than one year of age. Pediatr Allergy Immunol. 2020 Feb;31(2):203-206. doi: 10.1111/pai.13135. Epub 2019 Nov 7. No abstract available.

  PMID: 31594030 DERIVED

• Gjengsto Hunderi JO, Lodrup Carlsen KC, Rolfsjord LB, Carlsen KH, Mowinckel P, Skjerven HO. Parental severity assessment predicts supportive care in infant bronchiolitis. Acta Paediatr. 2019 Jan;108(1):131-137. doi: 10.1111/apa.14443. Epub 2018 Jun 29.

  PMID: 29889987 DERIVED

• Berents TL, Carlsen KCL, Mowinckel P, Skjerven HO, Rolfsjord LB, Nordhagen LS, Kvenshagen B, Hunderi JOG, Bradley M, Thorsby PM, Carlsen KH, Gjersvik P. Weight-for-length, early weight-gain velocity and atopic dermatitis in infancy and at two years of age: a cohort study. BMC Pediatr. 2017 Jun 7;17(1):141. doi: 10.1186/s12887-017-0889-6.

  PMID: 28592289 DERIVED

• Rolfsjord LB, Bakkeheim E, Berents TL, Alm J, Skjerven HO, Carlsen KH, Mowinckel P, Sjobeck AC, Carlsen KCL. Morning Salivary Cortisol in Young Children: Reference Values and the Effects of Age, Sex, and Acute Bronchiolitis. J Pediatr. 2017 May;184:193-198.e3. doi: 10.1016/j.jpeds.2017.01.064. Epub 2017 Mar 8.

  PMID: 28284475 DERIVED

• Skjerven HO, Megremis S, Papadopoulos NG, Mowinckel P, Carlsen KH, Lodrup Carlsen KC; ORAACLE Study Group. Virus Type and Genomic Load in Acute Bronchiolitis: Severity and Treatment Response With Inhaled Adrenaline. J Infect Dis. 2016 Mar 15;213(6):915-21. doi: 10.1093/infdis/jiv513. Epub 2015 Oct 27.

  PMID: 26508124 DERIVED

• Skjerven HO, Rolfsjord LB, Berents TL, Engen H, Dizdarevic E, Midgaard C, Kvenshagen B, Aas MH, Hunderi JOG, Stensby Bains KE, Mowinckel P, Carlsen KH, Lodrup Carlsen KC. Allergic diseases and the effect of inhaled epinephrine in children with acute bronchiolitis: follow-up from the randomised, controlled, double-blind, Bronchiolitis ALL trial. Lancet Respir Med. 2015 Sep;3(9):702-708. doi: 10.1016/S2213-2600(15)00319-7. Epub 2015 Aug 25.

  PMID: 26321593 DERIVED

• Skjerven HO, Hunderi JO, Brugmann-Pieper SK, Brun AC, Engen H, Eskedal L, Haavaldsen M, Kvenshagen B, Lunde J, Rolfsjord LB, Siva C, Vikin T, Mowinckel P, Carlsen KH, Lodrup Carlsen KC. Racemic adrenaline and inhalation strategies in acute bronchiolitis. N Engl J Med. 2013 Jun 13;368(24):2286-93. doi: 10.1056/NEJMoa1301839.

  PMID: 23758233 DERIVED

Related Links

• Oslo University Hospital

MeSH Terms

Conditions

Bronchiolitis; Respiratory Aspiration

Interventions

Racepinephrine; Epinephrine; Sodium Chloride

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Karin C. Lødrup Carlsen, MD,pHD

  Ullevål University Hospital HF

  STUDY DIRECTOR

• Håvard O Skjerven, MD

  Ullevål University Hospital HF

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 6, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2013
• Last Updated: November 2, 2012

Record last verified: 2012-11

Locations

NO (9)