Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Goadsby

ORCID ID

Contact details

Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom

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 measures

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

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

http://www.boc-gases.com/

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19996400

Publication citations

  1. 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.

Editorial Notes