A case-control study evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.

A case-control study evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. - Combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016045

Enrollment

Registered

2014-12-26

Start date

2009-10-03

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

Interventions

Using Micro Air nebulizers and vibration mesh technology (NE-U07, Omron, Tokyo, Japan), patients receiving NAC combined with pirfenidone were treated twice daily with 352.4 mg of inhaled NAC, which wa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients diagnosed as IPF/UIP according to ATS/ERS/JRS/ALAT guidline. Stage III or IV according to JRS criteria. (1)adult (2)sex:male or female (3)patient who had declines in FVC of 10% or more during the 6 months before the study. (4)all patients must provide written informed consent

Exclusion criteria

Exclusion criteria: The exclusion criteria were (1) clinical features of idiopathic interstitial pneumonia other than IPF, (2) duration of pirfenidone therapy shorter than 1 month, due to adverse events, (3) poor adherence to inhaled NAC therapy, (4) an extent of emphysema greater than that of fibrotic change on HRCT, or physiological evidence of airflow obstruction, defined as a ratio of forced expiratory volume in 1 second (FEV1) to FVC of <0.7 or a residual volume >120%, and (5) evidence of coexisting respiratory infection or lung cancer

Design outcomes

Primary

Measure	Time frame
Change in forced vital capacity	—

Secondary

Measure	Time frame
Progression-free survival time Incidence of acute exacerbation	—

Countries

Japan

Contacts

Public Contactsusumu Sakamoto

Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo, Department of Respiratory Medicine

susumu1029@med.toho-u.ac.jp03-3762-4151

Outcome results

None listed

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