Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study 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
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 study start date
02/04/2003
Overall study 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(s)
Patient
Age group
Not Specified
Sex
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
England, United Kingdom
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/12/2009 | Yes | No |