Double-blind, placebo-controlled crossover trial of inhaled oxygen in the treatment of acute cluster headache
| ISRCTN | ISRCTN94092997 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94092997 |
| Secondary identifying numbers | CHO2 |
- Submission date
- 22/04/2007
- Registration date
- 15/06/2007
- Last edited
- 10/12/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Peter Goadsby
Scientific
Scientific
Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom
Study information
| 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 |
| Scientific title | |
| Study acronym | CHAO2 |
| Study objectives | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 30/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 55 |
| Key inclusion criteria | 1. Active Cluster headache 2. Attack duration between 45 minutes and three hours |
| Key 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 |
| Date of first enrolment | 02/04/2003 |
| Date of final enrolment | 30/04/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Neurology
London
WC1N 3BG
United Kingdom
WC1N 3BG
United Kingdom
Sponsor information
BOC Ltd (UK)
Industry
Industry
Chertsey Road
Windlesham
Surrey
GU20
United Kingdom
| Website | http://www.boc-gases.com/ |
|---|---|
"ROR" |
https://ror.org/052v1zn95 |
Funders
Funder type
Industry
BOC Gases (International)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/12/2009 | Yes | No |
