Phase II Study of Formoterol DPI

A Phase II, Randomized, Double-blind, Two-week 3 Way Cross-over, Placebo-Controlled Study Evaluating the Efficacy and Safety of Formoterol DPI Compared With Placebo in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221870

Enrollment

Registered

2012-07-30

Start date

2012-07-30

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

Interventions

investigational material(s) Generic name etc : Formoterol DPI INN of investigational material : Therapeutic category code : 229 Other agents affecting respiratory organs Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: COPD patients with post-bronchodilator FEV1 between 30 and 80 % of predicted .

Exclusion criteria

Exclusion criteria: - History or current diagnosis of asthma - Patient hospitalized for an acute COPD exacerbation within 3 months prior to screening visit, and others.

Design outcomes

Primary

Measure	Time frame
FEV1AUC0-6 The change from baseline in FEV1AUC0-6	—

Secondary

Measure	Time frame
Trough FEV1, and others. The change from baseline in trough FEV1, and others.	—

Outcome results

None listed

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