A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)

April 14, 2016 updated by: Hoffmann-La Roche

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N-Acetylcysteine in Patients With Idiopathic Pulmonary Fibrosis With Background Treatment of Pirfenidone

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
123

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
      • Innsbruck, Austria, 6020
      • Salzburg, Austria, 5020
  • Belgium
      • Bruxelles, Belgium, 1070
      • Leuven, Belgium, 3000
      • Mont-godinne, Belgium, 5530
  • Denmark
      • Aarhus, Denmark, 8000
      • Hellerup, Denmark, 2900
      • Odense C, Denmark, 5000
  • France
      • Bobigny, France, 93000
      • Brest, France, 29609
      • Bron, France, 69677
      • Dijon, France
      • Lille, France, 59037
      • Marseille cedex 20, France, 13915
      • Montpellier, France, 34295
      • Paris, France, 75877
      • Reims, France, 51092
      • Rennes, France, 35033
      • Toulouse, France, 31059
      • Tours, France, 37044
  • Germany
      • Bad Berka, Germany, 99437
      • Bamberg, Germany
      • Berlin, Germany, 10117
      • Berlin, Germany, 13125
      • Berlin, Germany, 14165
      • Bochum, Germany, 44789
      • Bonn, Germany, 53127
      • Coswig, Germany, 01640
      • Donaustauf, Germany, 93093
      • Essen, Germany, 45239
      • Freiburg, Germany
      • Gießen, Germany, 35392
      • Greifswald, Germany, 17475
      • Hamburg, Germany
      • Heidelberg, Germany, 69126
      • Immenhausen, Germany, 34376
      • Magdeburg, Germany, 39120
      • Marburg, Germany, 35037
      • Muenchen, Germany, 81377
      • Münnerstadt, Germany
      • Solingen, Germany, 42699
      • Würzburg, Germany
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
    • Friuli-Venezia Giulia
      • Cattinara Trieste, Friuli-Venezia Giulia, Italy, 34149
      • Trieste, Friuli-Venezia Giulia, Italy, 34129
    • Lazio
      • Roma, Lazio, Italy, 00133
    • Liguria
      • Catania, Liguria, Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20142
      • Monza, Lombardia, Italy, 20900
    • Piemonte
      • Orbassano, Piemonte, Italy, 10043
    • Toscana
      • Pisa, Toscana, Italy, 56124
      • Siena, Toscana, Italy, 53100
    • Veneto
      • Padova, Veneto, Italy
  • Sweden
      • Falun, Sweden, 79182
      • Lund, Sweden, 221 85
      • Stokholm, Solna, Sweden, 17176
      • Uppsala, Sweden, 751 85
  • United Kingdom
      • Bristol, United Kingdom, BS10-5NB
      • Cambridge, United Kingdom, CB23 3RE
      • Exeter, United Kingdom, EX2 5DW
      • Leeds, United Kingdom, LS9 7TF
      • Liverpool, United Kingdom, L9 7AL
      • London, United Kingdom
      • London, United Kingdom, NW1 2BU
      • London, United Kingdom, SW3 6NP
      • Oxford, United Kingdom
      • Sheffield, United Kingdom
      • Southampton, United Kingdom, SO16 6YD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Matching Placebo
Drug: Matching Placebo
Matching Placebo, oral administration, three times daily for 24 weeks.
Drug: Pirfenidone
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.
EXPERIMENTAL: N-Acetylcysteine
Drug: Pirfenidone
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.
Drug: N-acetylcysteine
N-acetylcysteine, 600 mg, oral administration, three times daily for 24 weeks.
OTHER: Pirfenidone
Background therapy
Drug: Pirfenidone
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Dose Reductions
Time Frame: From baseline up to 24 weeks
Percentage of participants with dose reductions in N-Acetylcysteine and placebo cohorts during the 24-week treatment period.
From baseline up to 24 weeks
Percentage of Participants With Early Treatment Discontinuations
Time Frame: From baseline up to 24 weeks
Percentage of participants with early treatment discontinuations in N-Acetylcysteine and placebo cohorts during the 24-week treatment period.
From baseline up to 24 weeks
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Until 28 days from last dose of study treatment (Week 28)
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.
Until 28 days from last dose of study treatment (Week 28)
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Time Frame: Until 28 days from last dose of study treatment (Week 28)
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.
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)
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)
Until 28 days from last dose of study treatment (Week 28)
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)
Until 28 days from last dose of study treatment (Week 28)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WA29976
  • 2012-000564-14 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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