077078; OUCRU # 17AV; B9RJIXO
Treatment of high altitude cough (HAC) with salmeterol 50 µg and fluticasone 250 µg, one puff twice daily (bid) on Mount Everest: a randomised controlled trial
In this study we want to test the hypothesis that inhaled salmeterol and flucatisone will be effective in the treatment of high altitude cough (HAC) in climbers at the base camp or while climbing Everest.
Oxford Tropical Research Ethics Committee (UK) approved on the 10th February 2010 (ref: 09-10)
Single centre randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
High altitude cough (HAC)
Please note that as of 30/07/10 this trial has been extended from 01/10/2010 to 01/10/2011
The study will take place in the Everest base camp (5300 m).
Mountaineers as they ascend to base camp will be made aware of this study by means of recruitment posters in the lodges that provide accommodation in the villages along the way to the Everest Base Camp and also by requests for volunteers at the daily altitude education talks given at the Himalayan Rescue Association post in Pheriche.
Interested mountaineers will have the study explained again by the Base Camp Clinic doctors and asked if they would like to participate. Study staff will ensure that participants do not meet any of the exclusion criteria.
Participants who consent will be assigned a study number and then requested to fill out a baseline modified Leicester Cough Questionnaire. They will also have their blood pressure, pulse, peak flow, O2 saturation measured and lung and heart auscultation carried out. Participants will then be randomised by computer program to either arm of the study:
1. Inhaled (through a rotahaler) salmeterol 50 µg and fluticasone 250 µg puffs twice daily (bid)
2. Placebo bid
The rotahalers have a 14 day supply of drugs. Their randomisation number will correspond to prepackaged identical rotahalers.
At day 7 and day 14, the subjects will again be re-assessed using the above parameters and again filling out the modified Leicester Cough Questionnaire. Unused medication will be collected and disposed of according to local regulations.
Primary outcome measures
The incidence of HAC using the modified the Leicester Cough Questionnaire before and after the rotahaler intervention. Measured at day 0, day 7 and day 14 of the study.
Secondary outcome measures
Measured at day 0, day 7 and day 14 of the study:
1. Oxygen saturation
2. Peak flow
4. Lung auscultation
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Healthy men or women
2. Between the ages of 18 and 65 years
3. Have HAC, defined as persistent (greater than 1 day) sometimes paroxysmal cough that disturbs sleep or daily activity or both. The cough may be dry or productive but is not associated with fever, chills, shortness of breath or desaturation less than 75% at Everest Base Camp (EBC) (5300 m).
Target number of participants
Participant exclusion criteria
1. Individuals with other obvious diagnoses causing cough (e.g., viral or bacterial pneumonia, high altitude pulmonary oedema [HAPE])
2. Unwillingness to comply with study treatment
3. Lack of informed consent
4. Individuals on beta agonists or steroid inhalers, steroid nasal sprays or oral steroids within the last 2 weeks
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University of Oxford (UK)
Centre for Tropical Medicine
The Wellcome Trust (UK) (grant ref: 077078)
Funding Body Type
Funding Body Subtype
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