Last updated: 11/04/2018 11:52:55
SERETIDE Plus Tiotropium Versus Individual Components
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomised, double-blind, double dummy, 3 way crossover study evaluating the effects of a combination of Seretide 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual agents (tiotropium bromide 18mcg alone and Seretide50/500mcg alone) in the treatment of subjects with COPD
Trial description: This study was designed to evaluate the effects on lung function of a combination of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice daily alone) in subjects with COPD. The study will utilise a three-way cross-over design with a 2-week wash-out period between each 2-week consecutive treatment period.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Tiotropium + SERETIDE 50/500
Enrollment:
41
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, tiotropium bromide
Collaborators
Not applicable
Study date(s)
December 2005 to August 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
- Has an established clinical history of COPD as defined as per the GOLD definition.
- Post-bronchodilator FEV1 of >30% to 75% of predicted normal at Visit 1, a post-bronchodilator FEV1 / FVC ratio = 70%.
- Has unstable COPD (Chronic Obstructive Pulmonary Disease).
Inclusion and exclusion criteria
Inclusion criteria:
- Has an established clinical history of COPD as defined as per the GOLD definition.
- Post-bronchodilator FEV1 of >30% to 75% of predicted normal at Visit 1, a post-bronchodilator FEV1 / FVC ratio = 70%.
- Current or ex-smoker with a smoking history of > 10 pack-years.
Exclusion criteria:
- Has unstable COPD (Chronic Obstructive Pulmonary Disease).
- Has a current medical diagnosis of asthma and/or allergic rhinitis or know respiratory disorders (lung cancer, sarcoidosis, tuberculosis or lung fibrosis) Requires regular (daily) or long term oxygen therapy (LTOT). (LTOT is defined as > 12 hours oxygen use per day).
Trial location(s)
Location
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9LT
Status
Study Complete
Location
GSK Investigational Site
Southampton, Hampshire, United Kingdom, SO16 6YD
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-07-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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