Idiopathic Pulmonary FibrosisPhase 4NCT02606877

A Study to Compare the Amount of Nintedanib and Pirfenidone in the Blood When Nintedanib and Pirfenidone Are Given Separately or in Combination

A Phase 4 study testing nintedanib and pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 9 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Idiopathic Pulmonary Fibrosis
What is being tested?: nintedanib and pirfenidone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 9 sitesUnited Kingdom
Study dates: 19 Apr 2016to 22 Mar 2017
Phase: Phase 4
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Any patients diagnosed with IPF and who comply with eligibility requirements may qualify for participation in the trial.
Written informed consent consistent with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local laws, signed prior to any study procedures being performed (including any required washout).
Male or female patients aged >=40 years at Visit 1
IPF diagnosis, based upon the American Thoracic Society (ATS)/European Respiratory Society(ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) 2011 guideline and chest high-resolution computed tomography (HRCT) scan.
Force Vital Capacity (FVC) >=50% of predicted normal at Visit 1
Diffusing capacity of the Lung for Carbon monoxide (DLCO) (corrected for Hb [visit 1]): 30%-79% predicted of normal at visit 2. (test can be performed at visits 1 or 2, or during the screening period)
Currently treated with pirfenidone at full dose (this is only for patients going into Group 2).

Who cannot join

Alanine transaminase (ALT), Aspartate aminotransferase (AST) >1.5 fold upper limit of normal (ULN) at visit 1.
Total bilirubin >1.5 fold ULN at visit 1.
Underlying chronic liver disease (Child Pugh A, B, or C hepatic impairment)
Relevant airways obstruction (i.e. pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/FVC <0.7 at visit 1).
History of myocardial infarction within 6 months of visit 1 or unstable angina within 1 month of visit 1.
Bleeding Risk:

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Known genetic predisposition to bleeding
Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, dabigatran, heparin, hirudin, etc.) or high dose antiplatelet therapy.
History of haemorrhagic central nervous system (CNS) event within 12 months prior to visit 1.
History of haemoptysis or haematuria, active gastro-intestinal bleeding or ulcers and/or major injury or surgery within 3 months prior to visit 1.
International normalised ratio (INR) >2 at visit 1.
Prothrombin time (PT) and partial thromboplastin time (PTT) >150% of institutional ULN at visit 1.
Planned major surgery during the trial participation, including lung transplantation, major abdominal or major intestinal surgery.
History of thrombotic event (including stroke and transient ischemic attack) within 12 months of visit 1.
Severe renal impairment (Creatinine clearance <30 mL/min calculated by Cockcroft-Gault formula at visit 1) or end-stage renal disease requiring dialysis.
Treatment with n-acetylcysteine, prednisone >15 mg daily or >30 mg every 2 days OR equivalent dose of other oral corticosteroids or fluvoxamine within 2 weeks of visit 2.
Treatment with azathioprine, cyclophosphamide, cyclosporine as well as any other investigational drug within 8 weeks of visit 2.
Previous treatment with pirfenidone in the past three months prior to Visit 2 (Group 1 only).
Previous treatment with nintedanib in the past 14 days prior to Visit 2.
Permanent discontinuation of nintedanib or pirfenidone in the past due to adverse events considered drug-related.
Known hypersensitivity to nintedanib, pirfenidone or their excipients; or to peanut or soya.
A disease or condition which in the opinion of the investigator may interfere with testing procedures or put the patient at risk when participating in this trial.
Alcohol or drug abuse, which in the opinion of the treating physician would interfere with treatment.
Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Women of childbearing potential not using highly effective methods of birth control per ICH M3, note 3, highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner. Barrier contraceptives (e.g. male condom or diaphragm) are acceptable if used in combination with spermicides (e.g. foam, gel). Contraception must be used for 28 days prior to and 3 months after nintedanib and pirfenidone administration.
Patients not able to understand and follow study procedures including completion of diaries without help.
Current smoker (vaping and e-cigarettes are acceptable)

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United Kingdom9 sites

Southmead Hospital
Bristol, BS10 5NB
Papworth Hospital
Cambridge, CB23 3RE
Glenfield Hospital
Leicester, LE3 9QP
University College London Hospital
London, NW1 2PG
Guy's Hospital
London, SE1 9RT
Royal Brompton Hospital
London, SW3 6NP
Wythenshawe Hospital
Manchester, M23 9LT
Churchill Hospital
Oxford, OX3 7LE
Southampton General Hospital
Southampton, SO16 6YD

Other trials in United Kingdom

About this study

Official title: Investigation of Drug-drug Interaction Between Nintedanib and Pirfenidone in Patients With IPF (an Open Label, Multiple-dose, Two Group Study)

The primary objective of this study is to investigate the effect of steady state pirfenidone on the pharmacokinetics of nintedanib and its metabolites following oral administration of 2403 mg/day pirfenidone and to investigate the effect of steady state nintedanib on the pharmacokinetics of pirfenidone at steady state following oral administration of 150 mg bid nintedanib. There will be two cohorts of patients; the first one will consist of patients not treated with pirfenidone or nintedanib, while the second one will consist of patients on pirfenidone treatment.

Conditions: Idiopathic Pulmonary Fibrosis
Being tested: nintedanib, 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.

nintedanibDrug
pirfenidoneDrug

Study groups in NCT02606877
Study group	Role	What they receive
Treatment naïve	Experimental	Treatment naïve to pirfenidone Receives: Drug: nintedanib; Drug: pirfenidone
Pirfenidone-treated	Experimental	Treatment before with pirfenidone Receives: Drug: nintedanib; Drug: pirfenidone

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment naïve, Area Under the Concentration-time Curve of the Nintedanib in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz).
AUC0-tz , area under the concentration-time curve of nintedanib in plasma over the time interval from 0 to the last quantifiable concentration. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Measured: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.
Treatment naïve, Maximum Measured Concentration of Nintedanib in Plasma After Single Dose Administration (Cmax).
Cmax, maximum measured concentration of nintedanib in plasma. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Measured: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.
Pirfenidone-treated, Area Under the Concentration-time Curve of Pirfenidone in Plasma Over a Dosing Interval at Steady State (AUCτ,ss)
AUCτ,ss, area under the concentration-time curve of pirfenidone in plasma over a dosing interval at steady state. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Measured: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.
Pirfenidone-treated, Maximum Measured Concentration of Pirfenidone in Plasma at Steady State (Cmax,ss)
Cmax,ss, maximum measured concentration of pirfenidone in plasma at steady state. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Measured: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.

Secondary outcomes (1)

Treatment naïve, Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
AUC0-∞, area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Measured: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Apr 201622 Mar 2017

First posted17 Nov 2015 (estimated)
Study start19 Apr 2016
Primary completion22 Mar 2017
Study completion22 Mar 2017

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 Boehringer IngelheimThe 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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02606877
Sponsor's protocol ID: 1199.229
Other IDs: 2015-000732-15, 2015
Status last verified: Nov 2018
First submitted: 16 Nov 2015
Last updated: 4 Mar 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Idiopathic Pulmonary Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Drug-drug Interaction Between Nintedanib and Pirfenidone in Patients With IPF (an Open Label, Multiple-dose, Two Group Study)
ClinicalTrials.gov ID: NCT02606877
Acronym / sponsor ID: 1199.229
Conditions: Idiopathic Pulmonary Fibrosis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 19 Apr 2016 (actual)
Primary completion: 22 Mar 2017 (actual)
Study completion: 22 Mar 2017 (actual)
First posted: 17 Nov 2015 (estimated)
Results: Posted 4 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment naïve	Experimental	Drug: nintedanib, Drug: pirfenidoneTreatment naïve to pirfenidone
Pirfenidone-treated	Experimental	Drug: nintedanib, Drug: pirfenidoneTreatment before with pirfenidone

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Any patients diagnosed with IPF and who comply with eligibility requirements may qualify for participation in the trial.
Written informed consent consistent with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local laws, signed prior to any study procedures being performed (including any required washout).
Male or female patients aged >=40 years at Visit 1
IPF diagnosis, based upon the American Thoracic Society (ATS)/European Respiratory Society(ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) 2011 guideline and chest high-resolution computed tomography (HRCT) scan.
Force Vital Capacity (FVC) >=50% of predicted normal at Visit 1

Key exclusion criteria (27 listed)

Alanine transaminase (ALT), Aspartate aminotransferase (AST) >1.5 fold upper limit of normal (ULN) at visit 1.
Total bilirubin >1.5 fold ULN at visit 1.
Underlying chronic liver disease (Child Pugh A, B, or C hepatic impairment)
Relevant airways obstruction (i.e. pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/FVC <0.7 at visit 1).
History of myocardial infarction within 6 months of visit 1 or unstable angina within 1 month of visit 1.

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
nintedanib	Drug	Pirfenidone-treated, Treatment naïve
pirfenidone	Drug	Pirfenidone-treated, Treatment naïve

Primary outcome

Treatment naïve, Area Under the Concentration-time Curve of the Nintedanib in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz).
Time frame: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.
AUC0-tz , area under the concentration-time curve of nintedanib in plasma over the time interval from 0 to the last quantifiable concentration. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Treatment naïve, Maximum Measured Concentration of Nintedanib in Plasma After Single Dose Administration (Cmax).
Time frame: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.
Cmax, maximum measured concentration of nintedanib in plasma. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Pirfenidone-treated, Area Under the Concentration-time Curve of Pirfenidone in Plasma Over a Dosing Interval at Steady State (AUCτ,ss)
Time frame: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.
AUCτ,ss, area under the concentration-time curve of pirfenidone in plasma over a dosing interval at steady state. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.
Pirfenidone-treated, Maximum Measured Concentration of Pirfenidone in Plasma at Steady State (Cmax,ss)
Time frame: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.
Cmax,ss, maximum measured concentration of pirfenidone in plasma at steady state. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.

1 secondary outcome

Treatment naïve, Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.

Results and safety

Results posted to the registry on 4 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment naïve	20	16
Pirfenidone-treated	17	16

Primary outcome: Treatment naïve, Area Under the Concentration-time Curve of the Nintedanib in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz).

Time frame: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.. Geometric mean (Standard Error). Unit: nanogram*hour/mililitre [ng*h/mL]

Measure	Nintedanib + Pirfenidone (T1) n = 12	Nintedanib (R1) n = 17
Value	150.31 (1.18)	169.69 (1.15)

Nintedanib + Pirfenidone (T1) vs Nintedanib (R1): T1/R1 Ratio (%): 88.58 (90% CI 65.40 to 119.97), ANOVA

Population analysed: Pharmacokinetic Analysis Set (PKS) - The PKS includes all patients in the treated set with at least one evaluable primary or secondary PK endpoint. (Observed cases)

Primary outcome: Treatment naïve, Maximum Measured Concentration of Nintedanib in Plasma After Single Dose Administration (Cmax).

Time frame: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.. Geometric mean (Standard Error). Unit: nanogram/mililitre [ng/mL]

Measure	Nintedanib + Pirfenidone (T1) n = 12	Nintedanib (R1) n = 17
Value	23.04 (1.23)	28.58 (1.19)

Nintedanib + Pirfenidone (T1) vs Nintedanib (R1): T1/R1 Ratio (%): 80.63 (90% CI 51.27 to 126.79), ANOVA

Population analysed: Pharmacokinetic Analysis Set (PKS) - The PKS includes all patients in the treated set with at least one evaluable primary or secondary PK endpoint. (Observed cases)

Primary outcome: Pirfenidone-treated, Area Under the Concentration-time Curve of Pirfenidone in Plasma Over a Dosing Interval at Steady State (AUCτ,ss)

Measure	Pirfenidone+Nintedanib (T2) n = 13	Pirfenidone (R2) n = 15
Value	39040.84 (1.07)	40178.46 (1.07)

Pirfenidone+Nintedanib (T2) vs Pirfenidone (R2): T2/R2 Ratio (%): 97.17 (90% CI 87.84 to 107.48), ANOVA

Population analysed: Pharmacokinetic Analysis Set (PKS) - The PKS includes all patients in the treated set with at least one evaluable primary or secondary PK endpoint. (Observed cases)

Primary outcome: Pirfenidone-treated, Maximum Measured Concentration of Pirfenidone in Plasma at Steady State (Cmax,ss)

Time frame: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.. Geometric mean (Standard Error). Unit: nanogram/mililitre [ng/mL]

Measure	Pirfenidone+Nintedanib (T2) n = 13	Pirfenidone (R2) n = 15
Value	10537.26 (1.08)	10591.08 (1.08)

Pirfenidone+Nintedanib (T2) vs Pirfenidone (R2): T2/R2 Ratio (%): 99.49 (90% CI 87.94 to 112.56), ANOVA

Population analysed: Pharmacokinetic Analysis Set (PKS) - The PKS includes all patients in the treated set with at least one evaluable primary or secondary PK endpoint. (Observed cases)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first drug administration until 28 days after last drug administration, up to 6 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment naïve	0 of 20 (0%)	13 of 20 (65%)	0 of 20
Pirfenidone-treated	0 of 17 (0%)	15 of 17 (88.2%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing nintedanib and pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 9 sites in United Kingdom.

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 7 inclusion and 27 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 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United Kingdom. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 4 Mar 2019). 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?

Treatment naïve, Area Under the Concentration-time Curve of the Nintedanib in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz). (time frame: Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02606877.

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 4 Mar 2019.