Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of MN-001 (Tipelukast) in Patients With Idiopathic Pulmonary Fibrosis (NCT NCT02503657)

The study was conducted at a single site.

In the double-blind period, participants were randomly assigned to receive MN-001 or placebo in a 2:1 ratio, meaning that 10 participants received MN-001 and 5 participants received placebo. In the Open-label period, all 15 participants who completed the double-blind period received MN-001.

Safety, Tolerability, and Efficacy of MN-001 (Tipelukast) in Patients With Idiopathic Pulmonary Fibrosis

Predicted forced vital capacity (FVC) is a reference value for lung function based on your age, height, sex, and ethnicity measured by a spirometer and is an established method of pulmonary function. FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters (L).

FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters (L). The mean relative change was calculated as 100\*\[FVC (L) at Week 26 - FVC (L) at baseline\].

FVC(%pred.) refers to the expected FVC for a healthy individual with the same age, sex, height, and weight. The actual FVC result is then expressed as a percentage of this predicted value; values of 80% or higher are generally considered normal and indicate no significant impairment.

FVC (%pred/) refers to the expected FVC for a healthy individual with the same age, sex, height, and weight. The actual FVC result is then expressed as a percentage of this predicted value; values of 80% or higher are generally considered normal and indicate no significant impairment. Relative change is measured as percent (%) change from FVC (%pred.).

The semiannual rates of change in FVC, measured in liters, were estimated using simple linear regression, with time measured in half-years.

Treatment-related serious adverse events (TRSAEs) are defined as possibly related, probably related, or related to MN-001 treatment.

The Modified Medical Research Council Dyspnea Score is a simple grading system widely used in the assessment of dyspnea (difficulty breathing) in chronic respiratory diseases, such as IPF. The breathlessness scale comprises five statements that cover respiratory disability from 0 (zero) to 4, in which 0 = not troubled by breathlessness, except on strenuous exercise, 1= shortness of breath when hurrying on the level or walking up a slight hill, 2 = walks slower than people of the same age or has to stop for breath when walking at own pace on level ground, 3 = stops for breath after walking just 100 meters (100 yards) or after a few minutes, and 4 = too breathless to leave the house or breathless when dressing or undressing. A higher score corresponds to greater difficult in breathing.

The A Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis score is a quality-of-life questionnaire that has 13 domains (cough, dyspnea, forethought, sleep, mortality, exhaustion, emotional well-being, social participation, finances, independence, sexual health, relationships, therapy). The domain scores and the Total score from these domain scores are calculated by summation. Higher scores correspond to greater impairment. The Total score ranges from 74 to 370.

The number of participants who experienced worsening in IPF. Worsening of IPF is defined as acute IPF exacerbation, hospitalization due to respiratory symptoms, IPF-related fatal events, and/or lung transplantation.