Idiopathic Pulmonary FibrosisPhase 2NCT02707640
A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing N-acetylcysteine and Pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche at 69 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- N-acetylcysteine and Pirfenidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 69 sitesin 8 countries
- Study dates
- Aug 2013to Feb 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
69 sites in 8 countries.
69 sites in 8 countries
Germany22 sites
Study site
Bad Berka, 99437
Study site
Bamberg
Study site
Berlin, 10117
Study site
Berlin, 13125
Study site
Berlin, 14165
Study site
Bochum, 44789
Study site
Bonn, 53127
Study site
Coswig, 01640
Study site
Donaustauf, 93093
Study site
Essen, 45239
Study site
Freiburg im Breisgau
Study site
Giessen, 35392
Study site
Greifswald, 17475
Study site
Hamburg
Study site
Heidelberg, 69126
Study site
Immenhausen, 34376
Study site
Magdeburg, 39120
Study site
Marburg, 35037
Study site
München, 81377
Study site
Münnerstadt
Study site
Solingen, 42699
Study site
Würzburg
France12 sites
Study site
Bobigny, 93000
Study site
Brest, 29609
Study site
Bron, 69677
Study site
Dijon
Study site
Lille, 59037
Study site
Marseille, 13915
Study site
Montpellier, 34295
Study site
Paris, 75877
Study site
Reims, 51092
Study site
Rennes, 35033
Study site
Toulouse, 31059
Study site
Tours, 37044
Italy11 sites
Study site
Catania, Liguria
Study site
Cattinara Trieste, Friuli Venezia Giulia, 34149
Study site
Milan, Lombardy, 20142
Study site
Monza, Lombardy, 20900
Study site
Naples, Campania, 80131
Study site
Orbassano, Piedmont, 10043
Study site
Padova, Veneto
Study site
Pisa, Tuscany, 56124
Study site
Rome, Lazio, 00133
Study site
Siena, Tuscany, 53100
Study site
Trieste, Friuli Venezia Giulia, 34129
United Kingdom11 sites
Study site
Bristol, BS10-5NB
Study site
Cambridge, CB23 3RE
Study site
Exeter, EX2 5DW
Study site
Leeds, LS9 7TF
Study site
Liverpool, L9 7AL
Study site
London, NW1 2BU
Study site
London, SW3 6NP
Study site
London
Study site
Oxford
Study site
Sheffield
Study site
Southampton, SO16 6YD
Sweden4 sites
Study site
Falun, 79182
Study site
Lund, 221 85
Study site
Stokholm, Solna, 17176
Study site
Uppsala, 751 85
Austria3 sites
Study site
Graz, 8036
Study site
Innsbruck, 6020
Study site
Salzburg, 5020
Belgium3 sites
Study site
Brussels, 1070
Study site
Leuven, 3000
Study site
Mont-godinne, 5530
Denmark3 sites
Study site
Aarhus, 8000
Study site
Hellerup, 2900
Study site
Odense C, 5000
About this study
Official title: 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Matching Placebo, N-acetylcysteine, Pirfenidone
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matching PlaceboDrug
Matching Placebo, oral administration, three times daily for 24 weeks.
N-acetylcysteineDrug
N-acetylcysteine, 600 mg, oral administration, three times daily for 24 weeks.
PirfenidoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Matching Placebo | Placebo comparator | Not described Receives: Drug: Matching Placebo; Drug: Pirfenidone |
| N-Acetylcysteine | Experimental | Not described Receives: Drug: N-acetylcysteine; Drug: Pirfenidone |
| Pirfenidone | Other | Background therapy Receives: Drug: Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Dose Reductions
Percentage of participants with dose reductions in N-Acetylcysteine and placebo cohorts during the 24-week treatment period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Until 28 days from last dose of study treatment (Week 28)
Percentage of Participants With Treatment-Emergent Deaths of All Causes
Measured: 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
Measured: Until 28 days from last dose of study treatment (Week 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startAug 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707640
- Sponsor's protocol ID
- WA29976
- Other IDs
- 2012-000564-14
- Status last verified
- Apr 2016
- First submitted
- 9 Mar 2016
- Last updated
- 20 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02707640
- Acronym / sponsor ID
- WA29976
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Posted 20 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Matching Placebo | Placebo comparator | Drug: Matching Placebo, Drug: Pirfenidone |
| N-Acetylcysteine | Experimental | Drug: N-acetylcysteine, Drug: Pirfenidone |
| Pirfenidone | Other | Drug: PirfenidoneBackground therapy |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Matching PlaceboMatching Placebo, oral administration, three times daily for 24 weeks. | Drug | Matching Placebo |
| N-acetylcysteineN-acetylcysteine, 600 mg, oral administration, three times daily for 24 weeks. | Drug | N-Acetylcysteine |
| PirfenidonePirfenidone, 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 | Matching Placebo, N-Acetylcysteine, Pirfenidone |
Primary outcome
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.
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.
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.
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.
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
69 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetylcysteine and Pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche at 69 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in Germany, France, Italy, United Kingdom, Sweden and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Dose Reductions (time frame: From baseline up to 24 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016.