Efficacy and safety of inhaled formoterol in Japanese COPD patients with %FEV1>=80%

Efficacy and safety of inhaled formoterol in Japanese COPD patients with %FEV1>=80% - Efficacy and safety of inhaled formoterol in Japanese COPD patients with %FEV1>=80%

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019118

Enrollment

Registered

2015-09-25

Start date

2015-09-14

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

Japanese COPD patients with %FEV1&gt

Interventions

Patients receives inhaled formoterol 9 micro g twice daily via turbuhaler for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and female patients >= 40 years of age with a clinical diagnosis of COPD (post-bronchodilator FEV1 >= 80% of predicted norma, and post-bronchodilator FEV1/FVC < 70%) are eligible for inclusion. Patients are also required to have a crrent or previous smoking history of >= 10 pack-years.

Exclusion criteria

Exclusion criteria: Key exclusion criteria ware: a history or current clinical diagnosis of asthma or atopic disease such as allergic rhinitis; positive to specific IgE for environmental allergens; positive results of a methacholine inhalation challenge (<10,000 micro g/ml); use of long acting beta2-aganist, long acting muscarinic antagonist, theophylline, inhaled/oral/intravenous steroid, leukotriene receptor antagonist; sensitivity to the study drug; poor inhalation technique of the study drug; exhaled nitric oxide over 22 ppb in ex smoker or 18 ppb in current smoker (NIOX MINO); respiratory infection or respiratory tract disorder other than COPD; unstable ischemic heart disease or any other relevant cardiovascular disorder; women of childbearing potential or of breast-feeding; mental disorder or psychiatric symptom; several medical conditions prohibiting partitipation

Design outcomes

Primary

Measure	Time frame
The primary outcome is change from baseline FEV1 to the end of tratment period in FEV1 60-min post-dose.	—

Countries

Japan

Contacts

Public ContactJohsuke Hara

Cellular Transplantation Biology, Kanazawa University Graduate School of Medicine Respiratory Medicine

hara0728@gmail.com076-265-2276

Outcome results

None listed

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

Efficacy and safety of inhaled formoterol in Japanese COPD patients with %FEV1&gt;=80%