| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN94092997 |
| Date ISRCTN assigned | 15/06/2007 |
| Local reference number(s) | CHO2 |
| Public title | Double-blind, placebo-controlled crossover trial of inhaled oxygen in the treatment of acute cluster headache |
| Scientific title |
|
| Acronym | CHAO2 |
| Disease/condition/study domain | Cluster headache |
| Study hypothesis | Oxygen is a more effective treatment of acute cluster headache than air. |
| Design/methodology | Double-blind, placebo-controlled, cross-over randomised trial. |
| Research ethics review | The National Hospital for Neurology and Neurosurgery, approved on 3 March 2003 (ref: 01/N122)
|
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Active Cluster headache
2. Attack duration between 45 minutes and three hours |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 02/04/2003 |
| Anticipated end date | 30/04/2007 |
| Status of trial | Completed |
| Target number of participants | 55 |
| Interventions | 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. |
| Primary outcome measure(s) | Proportion of patients pain free after 15 minutes of treatment comparing oxygen and air. |
| Secondary outcome measure(s) | 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 |
| Sources of funding | BOC Gases (International) |
| Sponsor name | BOC Ltd (UK) |
| Sponsor details | Chertsey Road
Windlesham
Surrey
United Kingdom
GU20 |
| Sponsor website | http://www.boc-gases.com/ |
| Contact name | Prof Peter Goadsby |
| Contact details | Institute of Neurology
Queen Square
London
United Kingdom
WC1N 3BG |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN94092997 |
| Date last extracted from ISRCTN register | 17/04/2008 |
