127
Participants
Start Date
June 30, 2011
Primary Completion Date
June 27, 2014
Study Completion Date
June 27, 2014
Blood sample
Blood samples will be collected from all patients at enrolment, at follow-up visits, at exacerbation visits, and during the final visit.
Sputum sample
Sputum will be collected from all patients at enrolment, at monthly follow-up visits, at exacerbation visits, and during the final visit. Sputum will be obtained by spontaneous expectoration or induced by stimulation according to standard methods.
Nasopharyngeal swab
Nasopharyngeal swabs will be collected from all patients at enrolment and from a subcohort of 30 patients at monthly follow-up visits and at exacerbation visits during the first year.
Urine sample
Urine samples will be taken at enrolment and exacerbation visits from all subjects and from the same subcohort of 30 patients providing nasopharyngeal swabs, at monthly follow-up visits during the first year.
End tidal breath sample
Breath samples will be collected from all patients at enrolment, at follow-up visits (monthly), at exacerbation visits, and during the final visit.
Data collection
Patient interview, diary cards review and questionnaires completion
Tests
Urine pregnancy test, chest CT-scan, lung function testing and 6-min walk test
GSK Investigational Site, Southampton
Lead Sponsor
GlaxoSmithKline
INDUSTRY