NCT00287716

Brief Summary

The objectives of this study are to assess the safety and efficacy of treatment with pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone 1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
435

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

July 14, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2008

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

June 13, 2011

Completed
Last Updated

May 22, 2017

Status Verified

April 1, 2017

Enrollment Period

2.3 years

First QC Date

February 6, 2006

Results QC Date

June 2, 2010

Last Update Submit

April 18, 2017

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

IdiopathicPulmonaryFibrosisLungPirfenidoneInterMune

Outcome Measures

Primary Outcomes (1)

  • Absolute Change in Percent Predicted Forced Vital Capacity (FVC)

    Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72.

    From baseline up to 72 weeks

Secondary Outcomes (7)

  • Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC)

    baseline up to 72 weeks

  • Progression-free Survival (PFS)

    Baseline to Week 72

  • Change in Six-Minute Walk Test (6MWT)Distance

    Baseline to Week 72

  • Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test

    Baseline to Week 72

  • Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs

    Baseline to Week 72

  • +2 more secondary outcomes

Study Arms (3)

2403 mg/day pirfenidone

ACTIVE COMPARATOR

Active arm 1, 2403 mg/day pirfenidone dose group.

Drug: Pirfenidone

1197 mg/day pirfenidone

ACTIVE COMPARATOR

Active arm 2, 1197 mg/day pirfenidone.

Drug: Pirfenidone

placebo

PLACEBO COMPARATOR

Placebo equivalent.

Drug: Placebo

Interventions

PirfenidoneDRUG

1197 or 2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study.

1197 mg/day pirfenidone2403 mg/day pirfenidone
PlaceboDRUG

Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study.

placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of idiopathic pulmonary fibrosis
  • to 80 years of age
  • Forced Vital Capacity greater than or equal to 50% predicted value
  • Carbon monoxide diffusing capacity greater than or equal to 35% predicted value
  • either Forced Vital Capacity or Carbon monoxide diffusing capacity less than or equal to 90% predicted value
  • no improvement in past year
  • able to walk 150 meters in 6 minutes and maintain saturation greater than or equal to 83% while on no more than 6 liters per minute (L/min) supplemental oxygen

You may not qualify if:

  • unable to undergo pulmonary function testing
  • evidence of significant obstructive lung disease or airway hyper-responsiveness
  • in opinion of investigator patient is expected to need and be eligible for a lung transplant within 72 weeks after randomization
  • active infection
  • liver disease
  • cancer or other medical condition likely to result in death within 2 years
  • diabetes
  • pregnancy or lactation
  • substance abuse
  • personal or family history of long QT (Q wave,T wave) syndrome
  • other IPF treatment
  • unable to take study medication
  • withdrawal from other IPF trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

InterMune, Inc.

Brisbane, California, 94005, United States

Location

Related Publications (14)

  • Behr J, Nathan SD, Costabel U, Albera C, Wuyts WA, Glassberg MK, Haller H Jr, Alvaro G, Gilberg F, Samara K, Lancaster L. Efficacy and Safety of Pirfenidone in Advanced Versus Non-Advanced Idiopathic Pulmonary Fibrosis: Post-Hoc Analysis of Six Clinical Studies. Adv Ther. 2023 Sep;40(9):3937-3955. doi: 10.1007/s12325-023-02565-3. Epub 2023 Jun 30.

    PMID: 37391667DERIVED

  • Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.

    PMID: 35688625DERIVED

  • Kreuter M, Lee JS, Tzouvelekis A, Oldham JM, Molyneaux PL, Weycker D, Atwood M, Kirchgaessler KU, Maher TM. Monocyte Count as a Prognostic Biomarker in Patients with Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2021 Jul 1;204(1):74-81. doi: 10.1164/rccm.202003-0669OC.

    PMID: 33434107DERIVED

  • Glassberg MK, Nathan SD, Lin CY, Morgenthien EA, Stauffer JL, Chou W, Noble PW. Cardiovascular Risks, Bleeding Risks, and Clinical Events from 3 Phase III Trials of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. Adv Ther. 2019 Oct;36(10):2910-2926. doi: 10.1007/s12325-019-01052-y. Epub 2019 Aug 10.

    PMID: 31401786DERIVED

  • Nathan SD, Costabel U, Albera C, Behr J, Wuyts WA, Kirchgaessler KU, Stauffer JL, Morgenthien E, Chou W, Limb SL, Noble PW. Pirfenidone in patients with idiopathic pulmonary fibrosis and more advanced lung function impairment. Respir Med. 2019 Jul;153:44-51. doi: 10.1016/j.rmed.2019.04.016. Epub 2019 Apr 24.

    PMID: 31153107DERIVED

  • Kreuter M, Lederer DJ, Molina-Molina M, Noth I, Valenzuela C, Frankenstein L, Weycker D, Atwood M, Kirchgaessler KU, Cottin V. Association of Angiotensin Modulators With the Course of Idiopathic Pulmonary Fibrosis. Chest. 2019 Oct;156(4):706-714. doi: 10.1016/j.chest.2019.04.015. Epub 2019 Apr 29.

    PMID: 31047956DERIVED

  • Nathan SD, Costabel U, Glaspole I, Glassberg MK, Lancaster LH, Lederer DJ, Pereira CA, Trzaskoma B, Morgenthien EA, Limb SL, Wells AU. Efficacy of Pirfenidone in the Context of Multiple Disease Progression Events in Patients With Idiopathic Pulmonary Fibrosis. Chest. 2019 Apr;155(4):712-719. doi: 10.1016/j.chest.2018.11.008. Epub 2018 Nov 22.

    PMID: 30472023DERIVED

  • Nathan SD, Lancaster LH, Albera C, Glassberg MK, Swigris JJ, Gilberg F, Kirchgaessler KU, Limb SL, Petzinger U, Noble PW. Dose modification and dose intensity during treatment with pirfenidone: analysis of pooled data from three multinational phase III trials. BMJ Open Respir Res. 2018 Aug 2;5(1):e000323. doi: 10.1136/bmjresp-2018-000323. eCollection 2018.

    PMID: 30116539DERIVED

  • Neighbors M, Cabanski CR, Ramalingam TR, Sheng XR, Tew GW, Gu C, Jia G, Peng K, Ray JM, Ley B, Wolters PJ, Collard HR, Arron JR. Prognostic and predictive biomarkers for patients with idiopathic pulmonary fibrosis treated with pirfenidone: post-hoc assessment of the CAPACITY and ASCEND trials. Lancet Respir Med. 2018 Aug;6(8):615-626. doi: 10.1016/S2213-2600(18)30185-1. Epub 2018 Jun 29.

    PMID: 30072107DERIVED

  • Paterniti MO, Bi Y, Rekic D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC.

    PMID: 28388260DERIVED

  • Kreuter M, Bonella F, Maher TM, Costabel U, Spagnolo P, Weycker D, Kirchgaessler KU, Kolb M. Effect of statins on disease-related outcomes in patients with idiopathic pulmonary fibrosis. Thorax. 2017 Feb;72(2):148-153. doi: 10.1136/thoraxjnl-2016-208819. Epub 2016 Oct 5.

    PMID: 27708114DERIVED

  • Nathan SD, Albera C, Bradford WZ, Costabel U, du Bois RM, Fagan EA, Fishman RS, Glaspole I, Glassberg MK, Glasscock KF, King TE Jr, Lancaster L, Lederer DJ, Lin Z, Pereira CA, Swigris JJ, Valeyre D, Noble PW, Wells AU. Effect of continued treatment with pirfenidone following clinically meaningful declines in forced vital capacity: analysis of data from three phase 3 trials in patients with idiopathic pulmonary fibrosis. Thorax. 2016 May;71(5):429-35. doi: 10.1136/thoraxjnl-2015-207011. Epub 2016 Mar 11.

    PMID: 26968970DERIVED

  • Lancaster L, Albera C, Bradford WZ, Costabel U, du Bois RM, Fagan EA, Fishman RS, Glaspole I, Glassberg MK, King TE Jr, Lederer DJ, Lin Z, Nathan SD, Pereira CA, Swigris JJ, Valeyre D, Noble PW. Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials. BMJ Open Respir Res. 2016 Jan 12;3(1):e000105. doi: 10.1136/bmjresp-2015-000105. eCollection 2016.

    PMID: 26835133DERIVED

  • Noble PW, Albera C, Bradford WZ, Costabel U, Glassberg MK, Kardatzke D, King TE Jr, Lancaster L, Sahn SA, Szwarcberg J, Valeyre D, du Bois RM; CAPACITY Study Group. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet. 2011 May 21;377(9779):1760-9. doi: 10.1016/S0140-6736(11)60405-4. Epub 2011 May 13.

    PMID: 21571362DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisFibrosis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Bill Bradford, MD, PhD
Organization
InterMune, Inc.
bbradford@intermune.com
(415) 466-2200

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 7, 2006

Study Start

July 14, 2006

Primary Completion

November 10, 2008

Study Completion

November 10, 2008

Last Updated

May 22, 2017

Results First Posted

June 13, 2011

Record last verified: 2017-04

Locations

US(1)