Treatment trial of high altitude cough

ISRCTN	ISRCTN76835758
DOI	https://doi.org/10.1186/ISRCTN76835758
Secondary identifying numbers	077078; OUCRU # 17AV; B9RJIXO

Submission date: 01/03/2010
Registration date: 16/04/2010
Last edited: 30/07/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Buddha Basnyat
Scientific

Lal Durbar
GPO Box 3596
Kathmandu
44600
Nepal

Study information

Study design	Single centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	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
Study acronym	17AV
Study objectives	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.
Ethics approval(s)	Oxford Tropical Research Ethics Committee (UK) approved on the 10th February 2010 (ref: 09-10)
Health condition(s) or problem(s) studied	High altitude cough (HAC)
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Salmeterol, fluticasone
Primary outcome measure	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 3. Pulse 4. Lung auscultation
Overall study start date	01/04/2010
Completion date	01/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	72
Key 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).
Key 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
Date of first enrolment	01/04/2010
Date of final enrolment	01/10/2011

Locations

Countries of recruitment

Nepal

Study participating centre

Lal Durbar

Kathmandu
44600
Nepal

Sponsor information

University of Oxford (UK)
University/education

Centre for Tropical Medicine, CCVTM
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
England
United Kingdom

Website	http://www.ox.ac.uk/
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Charity

The Wellcome Trust (UK) (grant ref: 077078)

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