A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Matching Placebo; N-acetylcysteine; Pirfenidone
Intervention description: 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.
Intervention MeSH terms: Acetylcysteine; Pirfenidone; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical symptoms consistent with IPF of >=3 months' duration (relative to Day 1)

          -  Must have been on a dose of pirfenidone not less than 1602 mg/day for at least 8 weeks
             prior to randomization at Day 1

          -  Able to understand the importance of adherence to study treatment and the study
             protocol and willing to follow all study requirements, including the concomitant
             medication restrictions, throughout the study

          -  Women of childbearing capacity were required to have a negative serum pregnancy test
             before treatment and must have agreed to maintain highly effective contraception by
             practicing abstinence or by using at least two methods of birth control from the date
             of consent through the end of the study

          -  Diagnosis of usual interstitial pneumonia (UIP) or IPF by high-resolution computed
             tomography (HRCT) and surgical lung biopsy. Previous HRCT scans, typically and if
             available, one at the point of time of diagnosis and one more recent, made during the
             last year before study inclusion, will be used and assessed by a central Reading
             Committee

        Exclusion Criteria:

          -  Significant clinical worsening of IPF between screening and Day 1 of study, in the
             opinion of the investigator

          -  Unlikely to comply with the requirements of this study, in the opinion of the
             investigator

          -  Patient-reported cigarette smoking within 3 months of screening or unwilling to avoid
             use of tobacco products throughout the study

          -  History of clinically significant environmental exposure known to cause pulmonary
             fibrosis (PF), including but not limited to drugs (such as amiodarone), asbestos,
             beryllium, radiation, and domestic birds

          -  Known cause of interstitial lung disease, including but not limited to radiation, drug
             toxicity, sarcoidosis, hypersensitivity pneumonitis, and cryptogenic organizing
             pneumonia

          -  Clinical diagnosis of any connective tissue disease, including but not limited to
             scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and
             rheumatoid arthritis

          -  Clinical evidence of active infection, including but not limited to bronchitis,
             pneumonia, sinusitis, urinary tract infection, or cellulitis (as a diffuse
             inflammation of connective tissue and or skin)

          -  Any history of malignancy likely to result in significant disability or likely to
             require significant medical or surgical intervention within the next 6 months
             (relative to Day 1). This does not include minor surgical procedures for localized
             cancer (e.g., basal cell carcinoma, squamous skin carcinoma)

          -  History of severe hepatic impairment or end-stage liver disease

          -  History of end-stage renal disease requiring dialysis

          -  History of unstable or deteriorating cardiac or pulmonary disease (other than IPF)
             within the previous 6 months (relative to Day 1)

          -  Any condition that, in the opinion of the investigator, may have been significantly
             exacerbated by the known side effects associated with the administration of
             N-acetylcysteine taken as a single medication

          -  Suspected intolerance, allergy, or hypersensitivity to pirfenidone or any of its
             components

          -  Known intolerance, allergy, or hypersensitivity to N-acetylcysteine or any of its
             components