Condition category
Respiratory
Date applied
01/03/2010
Date assigned
16/04/2010
Last edited
30/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Buddha Basnyat

ORCID ID

Contact details

Lal Durbar
GPO Box 3596
Kathmandu
44600
Nepal

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

077078; OUCRU # 17AV; B9RJIXO

Study information

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

Acronym

17AV

Study hypothesis

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

Oxford Tropical Research Ethics Committee (UK) approved on the 10th February 2010 (ref: 09-10)

Study design

Single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase II

Drug names

Salmeterol, fluticasone

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
3. Pulse
4. Lung auscultation

Overall trial start date

01/04/2010

Overall trial end date

01/10/2011

Reason abandoned

Eligibility

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).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

72

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

01/04/2010

Recruitment end date

01/10/2011

Locations

Countries of recruitment

Nepal

Trial participating centre

Lal Durbar
Kathmandu
44600
Nepal

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

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

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

Publication citations

Additional files

Editorial Notes