A randomized, comparative study of Budesonide/formoterol versus Fluticasone/Salmeterol in COPD with asthma patients to improve oxidative stress and inflammatory mediators

A randomized, comparative study of Budesonide/formoterol versus Fluticasone/Salmeterol in COPD with asthma patients to improve oxidative stress and inflammatory mediators - A randomized, comparative study of Budesonide/formoterol versus Fluticasone/Salmeterol in COPD with asthma patients to improve oxidative stress and inflammatory mediators

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005204

Enrollment

Registered

2011-03-06

Start date

2011-01-01

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

COPD with asthma

Interventions

At first, COPD with asthma patients are assinged with FP/SM( Adair) 50ug/250ug 2 BLY per day for 4 weeks as a standard. Then, half patients are assigned randomly to BUD/FM 160/4.5ug 4 puffs per day an

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. patients who fit the criteria [1] and [2] are defined as COPD with asthma. Criteria [3] and [4] are for reference. [1] FEV1.0% less than 70% (measurements are done after inhaling 2 puffs of short acting beta-stimulants). [2] the history of sudden breathing difficulties (especially sudden wheeze or coughing at night or in the morning) that are not caused by labor or infections [3] history of asthma diagnosis by physicians [4] elevations of eosinophil in blood serum

Exclusion criteria

Exclusion criteria: 1.patients with other respiratory illness(IPF, ABPA, Chug-Strass syndrome, lung cancer, tuberculosis, bronchiectasis etc) 2.patients with circulatory illness( heart failure etc) 3.past allergic history to ICS

Design outcomes

Primary

Measure	Time frame
improvement in the urine samples of 8-OhdG/Cr and in the blood serum of TNF-a, hs-CRP amounts.	—

Secondary

Measure	Time frame
frequency of asthma attacks, ACT score, improvement in the respiratory functions(FEV1.0 etc), frequency of getting upper tract infections	—

Countries

Japan

Outcome results

None listed

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