Clinical trial NCT00325169: SERETIDE Plus Tiotropium Versus Individual Components
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Cross-over
Tiotropium
Triple
COPD
SERETIDE 50/500
Dyspnoea
Impulse oscillometry
Plethysmography
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-12
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: A randomised, double-blind, double dummy, 3 way cross-over study evaluating the effects of SERETIDE™ 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg alone and SERETIDE 50/500mcg alone) in the treatment of subjects with COPD

Eligibility 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).

Primary outcomes:
measure: AUC (0-4hrs, sGAW after morning dose of medication at day 14)
Secondary outcomes:
measure: Effects of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments on further elements of lung function, dyspnoea, symptoms and a patient/physician assessment of treatment effect.
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Southampton
country: United Kingdom
facility: GSK Investigational Site
state: Hampshire
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Singh D, Brooks J, Hagan G, Cahn A, O'Connor BJ. Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD. Thorax. 2008 Jul;63(7):592-8. doi: 10.1136/thx.2007.087213. Epub 2008 Feb 1.