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ISRCTN
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ISRCTN94092997
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DOI
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10.1186/ISRCTN94092997
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Double-blind, placebo-controlled crossover trial of inhaled oxygen in the treatment of acute cluster headache
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Scientific title
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Acronym
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CHAO2
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Serial number at source
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CHO2
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Study hypothesis
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Oxygen is a more effective treatment of acute cluster headache than air.
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Lay summary
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Ethics approval
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The National Hospital for Neurology and Neurosurgery, approved on 3 March 2003 (ref: 01/N122)
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Study design
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Double-blind, placebo-controlled, cross-over randomised trial.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cluster headache
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Participants - inclusion criteria
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1. Active Cluster headache
2. Attack duration between 45 minutes and three hours
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Participants - exclusion criteria
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1. Pregnant and lactating women will be excluded
2. Patients with moderate to severe chronic obstructive pulmonary disease will be excluded as the high-dose high-flow oxygen may affect their hypoxic respiratory drive.
3. Patients who cannot tolerate the oxygen mask in the correct fitting will be excluded from the study
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Anticipated start date
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02/04/2003
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Anticipated end date
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30/04/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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55
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Interventions
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Treatment of acute cluster headache with inhaled air or oxygen. Each participant will be randomised to treatment sequence of either AB or BA, where A is oxygen and B is inhaled air.
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Primary outcome measure(s)
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Proportion of patients pain free after 15 minutes of treatment comparing oxygen and air.
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Secondary outcome measure(s)
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1. Rendering the patient pain free at 30 minutes
2. Reduction in pain scale at 15, 30, 45 and 60 minutes
3. Need for rescue medication from 15 minutes after treatment
4. Overall response to the treatment and overall functional disability
5. Effect on associated symptoms
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Sources of funding
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BOC Gases (International)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19996400
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Contact name
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Prof
Peter
Goadsby
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Address
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Institute of Neurology
Queen Square
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City/town
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London
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Zip/Postcode
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WC1N 3BG
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Country
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United Kingdom
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Sponsor
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BOC Ltd (UK)
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Address
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Chertsey Road
Windlesham
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City/town
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Surrey
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Zip/Postcode
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GU20
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Country
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United Kingdom
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Sponsor website:
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http://www.boc-gases.com/
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Date applied
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22/04/2007
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Last edited
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10/12/2009
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Date ISRCTN assigned
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15/06/2007
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