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

UMIN ID: UMIN000016045

Registered date:26/12/2014

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Idiopathic pulmonary fibrosis
• Date of first enrollment: 2009/10/03
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 was diluted with saline to a total volume of 6 mL for 48 weeks.
Pirfenidone 1200-1800mg (control group)

Outcome(s)

• Primary Outcome: Change in forced vital capacity
• Secondary Outcome: Progression-free survival time Incidence of acute exacerbation

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo,
• Source(s) of Monetary Support: None