Phase III Significance Study of KRP-AB1102F DPI

A Phase III, Randomized, Double-blind, Active-controlled 12 week Study Evaluating the Efficacy and Safety of KRP-AB1102F DPI Compared with KRP-AB1102 DPI in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222230

Enrollment

600

Registered

2013-09-24

Start date

2013-09-24

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 : KRP-AB1102F DPI INN of investigational material : Therapeutic category code : 229 Other agents affecting respiratory organs Dosage and Administration fo

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
Trough FEV1 The change from baseline in trough FEV1 at Week 12	—

Secondary

Measure	Time frame
1h Post dose FEV1 The change from baseline in 1 h post dose FEV1 at Week 12	—

Outcome results

None listed

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