This is a Phase 2, randomized, double-blind, placebo-controlled safety and tolerability study of N-acetylcysteine or placebo in participants with mild to moderate idiopathic pulmonary fibrosis (IPF) receiving background pirfenidone therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
123
Matching Placebo, oral administration, three times daily for 24 weeks.
N-acetylcysteine, 600 mg, oral administration, three times daily for 24 weeks.
Pirfenidone, at least 1602 mg/day, oral administration, for 32 weeks, during the wash-out and screening period and for at least 8 weeks prior to randomization.
Percentage of Participants With Dose Reductions
Percentage of participants with dose reductions in N-Acetylcysteine and placebo cohorts during the 24-week treatment period.
Time frame: From baseline up to 24 weeks
Percentage of Participants With Early Treatment Discontinuations
Percentage of participants with early treatment discontinuations in N-Acetylcysteine and placebo cohorts during the 24-week treatment period.
Time frame: From baseline up to 24 weeks
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
Time frame: Until 28 days from last dose of study treatment (Week 28)
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect.
Time frame: Until 28 days from last dose of study treatment (Week 28)
Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Permanent Discontinuation of Study Treatment
Time frame: Until 28 days from last dose of study treatment (Week 28)
Percentage of Participants With Treatment-Emergent Deaths of All Causes
Time frame: Until 28 days from last dose of study treatment (Week 28)
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Graz, Austria
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Innsbruck, Austria
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Salzburg, Austria
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Brussels, Belgium
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Leuven, Belgium
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Mont-godinne, Belgium
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Aarhus, Denmark
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Hellerup, Denmark
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Odense C, Denmark
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Bobigny, France
...and 59 more locations
Percentage of Participants With Treatment-Emergent Adverse Events That Led to Dose Reduction or Temporary Discontinuation of Study Treatment
Time frame: Until 28 days from last dose of study treatment (Week 28)