The study comparing the effects of transitioning from long-acting bronchodilators: beta2 agonists (LABA) (inhaled) and anticholinergics (LAMA) (inhaled) treatment to the addition of inhaled corticosteroids (ICS) in the ICS/LAMA/LABA regimen on the clinical course of COPD, and the additional impact of ICS based on the results from MostGraph.

UMIN ID: UMIN000054323

Registered date:06/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic obstructive pulmonary disease
• Date of first enrollment: 2022/07/05
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Transition from 12 months of LAMA/LABA treatment to 12 months of ICS/LAMA/LABA treatment.
Transition from 12 months of ICS/LAMA/LABA treatment to 12 months of LAMA/LABA treatment.

Outcome(s)

• Primary Outcome: Temporal changes in IOS (impulse oscillometry system) over a period of one year, including R5 (respiratory system resistance values at 5 Hz) as an index of total airway resistance, R20 (respiratory system resistance values at 20 Hz) as an index of central airway resistance, X5 (reactance at 5 Hz) as an index of frequency-dependent resistance, and Fres (frequency of resonance) as an index of airway resistance components.
• Secondary Outcome: Changes in assessment items commonly used for observing the clinical course of COPD, such as lung function tests and clinical symptoms, before and after LAMA/LABA therapy and ICS/LAMA/LABA therapy.

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: "Patients with a history of bronchial asthma. Patients with an increase in FEV1 (forced expiratory volume in one second) of 200 ml or more before and after inhalation of short-acting bronchodilators (400 mcg salbutamol). Patients with peripheral blood eosinophil counts of 300 cells/uL or more. Patients with asthma-like symptoms believed to be due to allergic factors. Patients with a recorded serum IgE level exceeding 170 IU/mL. Patients already on LAMA, LABA, or ICS therapy outside of this study. Patients with conditions causing respiratory symptoms other than COPD, such as heart disease leading to congestion. Patients with angle-closure glaucoma. Patients with urinary disturbances due to conditions such as prostatic hypertrophy. Patients with infections for which there are no effective antibiotics or patients with deep-seated fungal infections. Other patients deemed unsuitable for participation in this study by the principal investigator or co-investigators.&quot

Related Information

• Primary Sponsor: Nippon Medical School
• Source(s) of Monetary Support: Nippon Medical School