Clinical Outcomes of Tiotropium Plus Fluticasone Propionate/Salmeterol Compared With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD) in Korea

The Korean Academy of Tuberculosis and Respiratory Diseases

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: tiotropium; Drug: tiotropium with fluticasone propionate/salmeterol (FSC)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00864812

112942

Details and patient eligibility

About

Study title

• A randomized, open label, multicenter, phase 4 study for the comparison of efficacy of tiotropium plus salmeterol/ fluticasone propionate compared with tiotropium alone in COPD patients

Study objectives

• To investigate clinical outcomes of combining tiotropium with fluticasone propionate/salmeterol (FSC) 250/50μg bid compared with tiotropium alone in patients with moderate or severe COPD in Korea

Study Design

• Randomized, open-label, multicenter, parallel-group, two group study

Study assessment

• FEV1
• Inspiratory capacity (IC)
• History of COPD exacerbation
• History of hospitalization for COPD exacerbation and all causes
• QoL (SGRQ-C)

Enrollment: 509 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects Aged 40 to 80 years.
• Subjects diagnosed with COPD.
• Tobacco smoking 10 pack-years or more.
• Subjects with post-bronchodilator FEV1/FVC < 0.7 and FEV1 < 65% predicted.

Exclusion criteria

• Subjects with a history of physician-diagnosed asthma or a respiratory disorder other than COPD which is clinically significant such as diffuse bilateral bronchiectasis.
• Subjects suffering from serious diseases likely to interfere with the study such as chronic congestive heart failure.
• Subjects who used systemic corticosteroids within 4 weeks prior to study entry.
• Subjects with any malignant disease.
• Subjects with a history of severe glaucoma, urinary tract obstruction.
• Previous lung volume reduction surgery.
• Subjects who are pregnant or breastfeeding.
• Subjects with a known hypersensitivity or intolerance to tiotropium or fluticasone-salmeterol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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509 participants in 2 patient groups

1

Experimental group

Description:

tiotropium with fluticasone propionate/salmeterol (FSC)

Treatment:

Drug: tiotropium with fluticasone propionate/salmeterol (FSC)

2

Active Comparator group

Description:

tiotropium

Treatment:

Drug: tiotropium