Assessments of the effect of Salmeterol and Fluticasone Propionate (SFC250) on the patients with chronic obstructive pulmonary disease by Impulse Oscillometry

Assessments of the effect of Salmeterol and Fluticasone Propionate (SFC250) on the patients with chronic obstructive pulmonary disease by Impulse Oscillometry - Assessments of the effect of Salmeterol and Fluticasone Propionate (SFC250) on the patients with chronic obstructive pulmonary disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004196

Enrollment

200

Registered

2010-09-13

Start date

2010-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Salmeterol and fluticasone propionate (25/250), 1 puff twice daily. Control(continue treatment without SFC)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient is able to read and understand the Informed Consent Form and he/she will sign the Informed Consent. 2. COPD patient, in the age range of 40-80 years, meets all of the following inclusion criteria. FEV1 < 80% of predicted value Current or former smokers with at least 10 pack years smoking history Patient is able to use Diskus. Patient is already treated with tiotropium Patient has COPD symptoms in spite of tiotropium treatment

Exclusion criteria

Exclusion criteria: 1. Patient is receiving inhaled steroids and long-acting beta2-agonists. 2. Patient is diagnosis as asthma. 3. Patient is decided as inappropriate for this study by the investigator.

Design outcomes

Primary

Measure	Time frame
To assess the additive effects of SFC250 on pulmonary functions (IOS, etc) of COPD patients treated by tiotropium on 4, 8,12weeks	—

Secondary

Measure	Time frame
a) Improvement of clinical symptoms (dyspnea, cough, sputum) and QOL b) Reduction of the exacerbations (follow up to 52weeks) c) Adverse events	—

Countries

Japan

Contacts

Public ContactMasamichi Mineshita

St.Marianna University School ofMedicine Division of Respiratory and Infectious diseases

m-mine@marianna-u.ac.jp044-977-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026