Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CHO2
Study information
Scientific title
Acronym
CHAO2
Study hypothesis
Oxygen is a more effective treatment of acute cluster headache than air.
Ethics approval
The National Hospital for Neurology and Neurosurgery, approved on 3 March 2003 (ref: 01/N122)
Study design
Double-blind, placebo-controlled, cross-over randomised trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cluster headache
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Proportion of patients pain free after 15 minutes of treatment comparing oxygen and air.
Secondary outcome measures
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
Overall trial start date
02/04/2003
Overall trial end date
30/04/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Active Cluster headache
2. Attack duration between 45 minutes and three hours
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
55
Participant exclusion criteria
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
Recruitment start date
02/04/2003
Recruitment end date
30/04/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Neurology
London
WC1N 3BG
United Kingdom
Sponsor information
Organisation
BOC Ltd (UK)
Sponsor details
Chertsey Road
Windlesham
Surrey
GU20
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
BOC Gases (International)
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19996400
Publication citations
-
Results
Cohen AS, Burns B, Goadsby PJ, High-flow oxygen for treatment of cluster headache: a randomized trial., JAMA, 2009, 302, 22, 2451-2457, doi: 10.1001/jama.2009.1855.