A prospective randomized, multicenter trial evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.

A prospective randomized, multicenter trial 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-UMIN000015508

Enrollment

150

Registered

2014-10-24

Start date

2015-01-01

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

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. (1)age:>=40years (2)sex:male or female (3)patient who intiate pirfenidone or under treatment with pirfenidone. (4)%FVC >= 50%, %DLco>= 35%, FEV1% > 70% (5)all patients must provide written informed consent (6)patient who did not have a treatment with inhaled NAC in previous 3 months.

Exclusion criteria

Exclusion criteria: 1.coexisting severe cardiovascular disease 2.coexisting severe liver disfunction 3.coexisting chronic kidney disease 4.patients who had a history of receiving chemotherapy or thoracic radiotherapy 5.patients who are pregnant or possibly pregnant, or nursing 6.patients who were unable to undergo physiologic tests 7.candidates for lung transplantation 8.improving physiologic tests or HRCT findings compared with previous 6 months. 9.patient who were administered with 20 mg/day or more of predonisolone during the preceding 3 months. Treated with NAC or nintedanib during the preceding 3 months. 10.treated with immunosuppressive agents. 11.coexisting pulmonary arterial hypertension, bronchial asthma,sarcoidosis,bronchiectasis, neoplasm,infectious disease. 12.patients who participated in another clinical study within 3 months prior to the administration period of the study drug. 13.considered ineligible for the study by the investigator.

Design outcomes

Primary

Measure	Time frame
Change in forced vital capacity	—

Secondary

Measure	Time frame
(1)Changes in distance and lowest SpO2 in 6-minute walk test, (2)Changes in vital capacity(VC), %VC, total lung capacity(TLC), %TLC, diffusion capacity of the lung for carbon monoxide (DLco), %DLco. A category analysis of FVC (5% or greater decline or decline less than 5% in FVC) (3) Changes in serum maker (KL-6, SP-D, SP-A) (4) Changes in high-resolution computed tomography (HRCT) findings (5) Changes in dyspnea (mMRC) (6) Changes in health Health-related Quality of Life (CAT score) (7) Safety (8) Incidence of acute exacerbation (9) Progression-free survival time (10) Survival	—

Measure

Time frame

(1)Changes in distance and lowest SpO2 in 6-minute walk test, (2)Changes in vital capacity(VC), %VC, total lung capacity(TLC), %TLC, diffusion capacity of the lung for carbon monoxide (DLco), %DLco. A category analysis of FVC (5% or greater decline or decline less than 5% in FVC) (3) Changes in serum maker (KL-6, SP-D, SP-A) (4) Changes in high-resolution computed tomography (HRCT) findings (5) Changes in dyspnea (mMRC) (6) Changes in health Health-related Quality of Life (CAT score) (7) Safety (8) Incidence of acute exacerbation (9) Progression-free survival time (10) Survival

—

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