NCT02503657Phase 2Completed

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

Study sponsor: MediciNova

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2020-12-07Actual

Enrollment · participants15Actual

Source updated2026-01-23Last update listed in the registry record

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Changes to this trial

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Posted 2026-01-23 · 1 field changed

Main study measure wording changed

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− Before

Measure: Change ~~from~~ ~~baseline~~ of ~~FVC~~ ~~(forced~~ ~~vital~~ ~~capacity)~~ at 26 ~~weeks~~

+ After

Measure: Absolute Change From Baseline in Forced Vital Capacity for 26 Weeks Measure: Percent Change in Forced Vital Capacity From Baseline to Week 26 Measure: Absolute Change From Baseline in Forced Vital Capacity (% Predicted) Measure: Relative Change From Baseline in Percent Predicted Forced Vital Capacity From Baseline to Week 26 Measure: Semiannual Rate of Decline of Disease Activity Based on Forced Vital Capacity

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Study details

Conditions studied

Idiopathic Pulmonary Fibrosis; IPF

Treatments or interventions studied

MN-001DrugAlso known as Tipelukast
PlaceboDrug

Primary outcomes · main study measures

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measure: Absolute Change From Baseline in Forced Vital Capacity for 26 Weeks; description: 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).; timeFrame: Baseline and Week 26 at the end of Double-blind treatment period.; measure: Percent Change in Forced Vital Capacity From Baseline to Week 26; description: 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\*\[FVC (L) at Week 26 - FVC (L) at baseline\].; timeFrame: Baseline, and Week 26 at the endpoint of the Double-blind treatment period.; measure: Absolute Change From Baseline in Forced Vital Capacity (% Predicted); description: 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.; timeFrame: Baseline and Week 26 at the end of Double-blind treatment period.; measure: Relative Change From Baseline in Percent Predicted Forced Vital Capacity From Baseline to Week 26; description: 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.).; timeFrame: Baseline and Week 26 at the end of Double-blind treatment period.; measure: Semiannual Rate of Decline of Disease Activity Based on Forced Vital Capacity; description: The semiannual rates of change in FVC, measured in liters, were estimated using simple linear regression, with time measured in half-years.; timeFrame: Baseline and Week 26 at the end of Double-blind treatment period.

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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