Open-label study of tiotropium/pirfenidone for idiopathic pulmonary fibrosis with emphysema

Open-label study of tiotropium/pirfenidone for idiopathic pulmonary fibrosis with emphysema - PS study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005793

Enrollment

Registered

2011-06-16

Start date

2009-11-01

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

Idiopathic pulmonary fibrosis (IPF) with centrilobular emphysema (CLE)

Interventions

tiotropium for 8 weeks and then tiotropium + pirfenidone for 44 weeks pirfenidone 44 weeks and then tiotropium + pirfenidone for 8 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with IPF diagnosed by ATS/ERS/JRS guideline 2011 and with CLE

Exclusion criteria

Exclusion criteria: Patients who are not eligible for the administration of tiotropium or pirfenidone. Patients who cannot undergo pulmonary function tests and/or 6 minutes walk test.

Design outcomes

Primary

Measure	Time frame
Change in FVC,FEV1,DLco, and DLco/VA	—

Secondary

Measure	Time frame
Time to progression Progression free survival Dyspnea (SGRQ) Change in brain natiuretic peptide Change in predicted right ventricular pressure Change in high-resolution CT findings Change in 6 minutes walk test	—

Countries

Japan

Contacts

Public ContactYutaka Usui

Saitma Medical University Department of Respiratory Medicine

yusui@saitama-med.ac.jp0492761319

Outcome results

None listed

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