Efficacy of formoterol inhalation in patients with chronic obstructive pulmonary disease: investigation of the effects on the central and peripheral airways starting from immediately after inhalation

Efficacy of formoterol inhalation in patients with chronic obstructive pulmonary disease: investigation of the effects on the central and peripheral airways starting from immediately after inhalation - Bronchodilator effects on the central and peripheral airways of formoterol inhalation treatment (BENEFIT Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013318

Enrollment

Registered

2014-03-07

Start date

2014-03-07

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 (COPD)

Interventions

9 mcg of formoterol is inhaled once daily. 18 mcg of tiotropium is inhaled once daily.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Smoking history 10 pack-year or more 2) COPD stage II or III (according to the 4th edition of Guidelines for the diagnosis and treatment of COPD published by the Japanese Respiratory Society)

Exclusion criteria

Exclusion criteria: 1) Patients with asthma 2) Treatment with oral corticosteroid 3) Insufficient inspiratory flow rate 4) Hospitalization within last 1 month 5) Emergency or unsheduled department visit for COPD within last 1 month 6) Respiratory infection within last 2 weeks 7) Cardiovascular disease 8) Lactating, pregnancy, or suspected pregnancy 9) Other unsuitable patients judged by the investigator

Design outcomes

Primary

Measure	Time frame
Area under the FEV1-time curve from 0 (before drug inhalation) to 120 minutes after inhalation (AUC)	—

Secondary

Measure	Time frame
(1) Changes in spirometry parameters (2) Changes in MostGraph parameters (3) Respiratory function questionnaire (4) Safety	—

Countries

Japan

Contacts

Public ContactHiroyuki Ohbayashi

Tohno Chuo Clinic Tohno Chuo Clinic

ohbayasi@nn.iij4u.or.jp0572-67-1118

Outcome results

None listed

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