Condition category
Respiratory
Date applied
21/09/2005
Date assigned
29/09/2005
Last edited
22/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.breathe-heliox.com

Contact information

Type

Scientific

Primary contact

Dr Parviz Habibi

ORCID ID

Contact details

Department of Paediatrics
Room 250
Wright Fleming Institute
St Mary's Campus
Imperial College London
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)20 7594 3990
p.habibi@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HP002A

Study information

Scientific title

Acronym

BREATHE

Study hypothesis

Helium-oxygen gas mixtures reduce the total duration of treatment needed in the management of bronchiolitis

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Bronchiolitis

Intervention

1. Heliox-21 +/- additional oxygen
2. Medical air +/- additional oxygen

Intervention type

Drug

Phase

Not Specified

Drug names

Helium-oxygen gas

Primary outcome measures

Total length of treatment needed

Secondary outcome measures

1. Proportion of cases needing continuous positive airway pressure (nCPAP)
2. Duration of nCPAP needed
3. Changes in clinical assessment parameters and measurements

Overall trial start date

03/10/2005

Overall trial end date

31/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Chronological age = 1 year or less
2. Bronchiolitis likely as a diagnosis
3. Requiring admission for treatment of respiratory distress or hypoxia (i.e. SpO2 <93%)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

298

Participant exclusion criteria

1. Any condition requiring immediate intubation (including apnoea or bradycardia)
2. Unable to maintain SpO2 >92% despite 15 l/min oxygen
3. Legal incapacity of parent/guardian to give consent
4. Participating in another drug trial in the past 4 weeks
5. Inappropriate for child to enter study, in clinician's opinion
6. Child has a tracheostomy
7. Readmitted (with a diagnosis of bronchiolitis) within 24 hours of exiting from the BREATHE study
8. If any of the following drugs were given prior to entry/enrolment into the BREATHE study:
a. Salbutamol or ipratropium/atrovent (less than 1 hour prior to entry into BREATHE)
b. Adrenaline (less than 1 hour prior to entry into BREATHE)
c. Systemic steroids (less than 4 hours prior to entry into BREATHE)

Recruitment start date

03/10/2005

Recruitment end date

31/08/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Paediatrics
London
W2 1PG
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

Faculty of Medicine
Level 2
Faculty Building
South Kensington Campus
Imperial College of Science
Technology & Medicine
Exhibition Road
London
SW7 2AZ
United Kingdom
+44 (0)20 7594 1188
gary.roper@imperial.ac.uk

Sponsor type

University/education

Website

http://www.imperial.ac.uk

Funders

Funder type

Industry

Funder name

BOC Medical

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23509160

Publication citations

  1. Results

    Chowdhury MM, McKenzie SA, Pearson CC, Carr S, Pao C, Shah AR, Reus E, Eliahoo J, Gordon F, Bland H, Habibi P, Heliox therapy in bronchiolitis: phase III multicenter double-blind randomized controlled trial., Pediatrics, 2013, 131, 4, 661-669, doi: 10.1542/peds.2012-1317.

Additional files

Editorial Notes