Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

• ClinicalTrials.gov Identifier: NCT00287729
• Recruitment Status: Completed
• First Posted: February 7, 2006
• Results First Posted: June 13, 2011
• Last Update Posted: April 17, 2017
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Pirfenidone; Drug: Placebo
• Enrollment: 344

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Pirfenidone (2403 mg/d)	Placebo
Arm/Group Description	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	placebo equivalent, given as 3 divided doses 3 times/day
Period Title: Overall Study
Started	171	173
Completed	137	142
Not Completed	34	31

Baseline Characteristics

Arm/Group Title		Pirfenidone (2403 mg/d)	Placebo	Total
Arm/Group Description		pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	placebo equivalent, given as 3 divided doses 3 times/day	Total of all reporting groups
Overall Number of Baseline Participants		171	173	344
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	171 participants	173 participants	344 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	70 40.9%	61 35.3%	131 38.1%
	>=65 years	101 59.1%	112 64.7%	213 61.9%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	171 participants	173 participants	344 participants
		66.8 (7.90)	67.0 (7.80)	66.9 (7.84)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	171 participants	173 participants	344 participants
	Female	48 28.1%	49 28.3%	97 28.2%
	Male	123 71.9%	124 71.7%	247 71.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	171 participants	173 participants	344 participants
United States		148	150	298
Europe		23	22	45
Australia		0	1	1

Outcome Measures

1. Primary Outcome

Title	Absolute Change in Percent Predicted Forced Vital Capacity(FVC)
Description	Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72. It is calculated as the simple difference between baseline Percent Predicted FVC measurements and week 72 Percent Predicted FVC measurements.
Time Frame	Baseline to week 72

Outcome Measure Data

Analysis Population Description

A modified intent-to-treat population of all randomized patients who received any amount of study drug is the primary population for efficacy and safety analyses. Missing FVC data due to death were assigned the worst rank and missing FVC data due to reasons other than death were imputed using the SSD method.

Arm/Group Title	Pirfenidone (2403 mg/d)	Placebo
Arm/Group Description:	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	placebo equivalent, given as 3 divided doses 3 times/day
Overall Number of Participants Analyzed	171	173
Mean (Standard Deviation); Unit of Measure: Change in Percent Predicted FVC
	-9 (19.58)	-10 (19.12)

2. Secondary Outcome

Title	Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity
Description	Based on the change in baseline percent predicted FVC at week 72, patients were assigned to 1 of 5 categories: mild decline (<10% but >=0% decline), moderate decline (<20% but >=10% decline), severe decline (>=20% decline), mild improvement (>0% but <10% improvement), or moderate improvement (>=10% improvement). Those who died or had a lung transplant before Week 72 were included in the severe decline category. The results indicate the number of patients who experience Categorical Change in Percent Predicted Forced Vital Capacity.
Time Frame	Baseline to week 72

Outcome Measure Data

Analysis Population Description

A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for all efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0% if the patient died before the protocol-specified time point.

Arm/Group Title	Pirfenidone (2403 mg/d)	Placebo
Arm/Group Description:	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	placebo equivalent, given as 3 divided doses 3 times/day
Overall Number of Participants Analyzed	171	173
Measure Type: Number; Unit of Measure: Patients
Decline >=20% or death or lung transplantation	20	23
Decline <20% but >= 10%	19	23
Decline <10% but > 0%	88	89
Improvement of >=0% but <10%	41	33
Improvement of >=10%	3	5

3. Secondary Outcome

Title	Progression-free Survival
Description	Progression is defined as the first occurrence of a 10% absolute decline from baseline in percent predicted Forced Vital Capacity, a 15% absolute decline from baseline in percent predicted hemoglobin(Hgb)-corrected carbon monoxide diffusing capacity (DLco), or, death.
Time Frame	Baseline to Week 72

Outcome Measure Data

Analysis Population Description

A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.

Arm/Group Title	Pirfenidone (2403 mg/d)	Placebo
Arm/Group Description:	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	placebo equivalent, given as 3 divided doses 3 times/day
Overall Number of Participants Analyzed	171	173
Measure Type: Number; Unit of Measure: Number of Patients with Progression
Death or Disease Progression	54	60
Decline in percent predicted FVC >=10%	31	41
Decline in percent predicted DLco >=15%	10	9
Death Before Disease Progression	13	10

4. Secondary Outcome

Title	Change in the Six-Minute Walk Test (6MWT) Distance
Description	The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test. This measure was calculated as the simple difference between baseline distanced walked over 6 minutes and week 72 distance walked over 6 minutes as measured in meters (m).
Time Frame	Baseline to Week 72

Outcome Measure Data

Analysis Population Description

A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0 meters if the patient had died before the protocol-specified time point.

Arm/Group Title	Pirfenidone (2403 mg/d)	Placebo
Arm/Group Description:	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	placebo equivalent, given as 3 divided doses 3 times/day
Overall Number of Participants Analyzed	171	173
Mean (Standard Deviation); Unit of Measure: Change in Distance Walked in Meters
	-45 (140)	-77 (128)

5. Secondary Outcome

Title	Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test
Description	The change from baseline to week 72 in worst oxygen saturation during the 6-Minute Walk Test as measure by Pulse Oximetry (SpO2) Level. It is calculated as the simple difference between baseline SpO2 measurements and week 72 SpO2 measurements.
Time Frame	Baseline to Week 72

Outcome Measure Data

Analysis Population Description

A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 83% if the patient died before the protocol-specified time point.

Arm/Group Title	Pirfenidone (2403 mg/d)	Placebo
Arm/Group Description:	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	placebo equivalent, given as 3 divided doses 3 times/day
Overall Number of Participants Analyzed	171	173
Mean (Standard Deviation); Unit of Measure: Change,Worst Oxygen Saturation (Percent)
	-1.9 (3.83)	-1.3 (6.63)

6. Secondary Outcome

Title	Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs
Description	The change from baseline to week 72 in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs. It is calculated as the simple difference between baseline DLco measurements and week 72 DLco measurements.
Time Frame	Baseline to Week 72

Outcome Measure Data

Analysis Population Description

A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0% if the patient died before the protocol-specified time point.

Arm/Group Title	Pirfenidone (2403 mg/d)	Placebo
Arm/Group Description:	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	placebo equivalent, given as 3 divided doses 3 times/day
Overall Number of Participants Analyzed	171	173
Mean (Standard Deviation); Unit of Measure: Change in Percent Predicted DLco
	-9.8 (12.61)	-9.2 (13.24)

7. Secondary Outcome

Title	Change in Dyspnea Score
Description	The mean change from baseline to week 72 in Dyspnea score was measured by the University of San Diego Shortness of Breath Questionnaire (UCSD SOBQ). The SOBQ is used to assess shortness of breath with various activities of daily living (for example, brushing ones teeth or mowing the lawn). Patients rated the severity of their shortness of breath experienced on an average day during the past week on a 6 point scale (0 to 5),with 0= not at all breathless, 4= severely breathless and 5= Maximally or unable to do because of breathlessness.
Time Frame	Baseline to Week 72

Outcome Measure Data

Analysis Population Description

A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.

Missing data were imputed by the SSD method if the patient was alive and imputed to a score of 120 if the patient died before the protocol-specified time point.

Arm/Group Title	Pirfenidone (2403 mg/d)	Placebo
Arm/Group Description:	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	placebo equivalent, given as 3 divided doses 3 times/day
Overall Number of Participants Analyzed	171	173
Mean (Standard Deviation); Unit of Measure: Change in Dyspnea Score
	11.9 (24.72)	13.9 (27.89)

8. Secondary Outcome

Title	Worsening of IPF
Description	Worsening of IPF was defined by the occurrence of any of the following events: Acute IPF exacerbation, IPF-related death, Lung transplantation, or Respiratory hospitalization.
Time Frame	Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.

Outcome Measure Data

Analysis Population Description

A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.

Arm/Group Title	Pirfenidone (2403 mg/d)	Placebo
Arm/Group Description:	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	placebo equivalent, given as 3 divided doses 3 times/day
Overall Number of Participants Analyzed	171	173
Measure Type: Number; Unit of Measure: Number of Patients Who Worsened
Woresening IPF	24	32
Acute IPF exacerbation	2	1
IPF-related death	3	6
Lung transplantation	2	2
Respiratory hospitalization	17	23
Patients Censored	146	141

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Pirfenidone (2403 mg/d)	Placebo
Arm/Group Description	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	placebo equivalent, given as 3 divided doses 3 times/day
All-Cause Mortality
	Pirfenidone (2403 mg/d)	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Pirfenidone (2403 mg/d)	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	53/171 (30.99%)	51/173 (29.48%)
Cardiac disorders
Angina Pectoris	1/171 (0.58%)	1/173 (0.58%)
Angina Unstable	0/171 (0.00%)	1/173 (0.58%)
Atrial Fibrillation	2/171 (1.17%)	1/173 (0.58%)
Cardiac Failure Congestive	1/171 (0.58%)	1/173 (0.58%)
Coronary Artery Disease	6/171 (3.51%)	0/173 (0.00%)
Coronary Artery Stenosis	0/171 (0.00%)	1/173 (0.58%)
Myocardial Infarction	1/171 (0.58%)	0/173 (0.00%)
Sick Sinus Syndrome	2/171 (1.17%)	0/173 (0.00%)
Supraventricular Tachycardia	1/171 (0.58%)	0/173 (0.00%)
Ventricular Tachycardia	1/171 (0.58%)	0/173 (0.00%)
Gastrointestinal disorders
Colitis	2/171 (1.17%)	0/173 (0.00%)
Diverticular Perforation	1/171 (0.58%)	1/173 (0.58%)
Ileus	0/171 (0.00%)	1/173 (0.58%)
Pancreatitis	1/171 (0.58%)	0/173 (0.00%)
General disorders
Asthenia	0/171 (0.00%)	1/173 (0.58%)
Chest Pain	1/171 (0.58%)	0/173 (0.00%)
Multi Organ Failure	1/171 (0.58%)	0/173 (0.00%)
Non-Cardiac Chest Pain	0/171 (0.00%)	1/173 (0.58%)
Pyrexia	1/171 (0.58%)	0/173 (0.00%)
Hepatobiliary disorders
Cholelithiasis	1/171 (0.58%)	0/173 (0.00%)
Hepatitis	1/171 (0.58%)	0/173 (0.00%)
Infections and infestations
Abdominal Abscess	0/171 (0.00%)	1/173 (0.58%)
Bronchiectasis	0/171 (0.00%)	1/173 (0.58%)
Bronchitis	0/171 (0.00%)	5/173 (2.89%)
Bronchitis Viral	1/171 (0.58%)	0/173 (0.00%)
Cholecystitis Infective	1/171 (0.58%)	0/173 (0.00%)
Chronic Sinusitis	1/171 (0.58%)	0/173 (0.00%)
Clostridium Difficile Colitis	0/171 (0.00%)	1/173 (0.58%)
Diverticulitis	0/171 (0.00%)	1/173 (0.58%)
Lobar Pneumonia	7/171 (4.09%)	7/173 (4.05%)
Pneumonia	1/171 (0.58%)	0/173 (0.00%)
Respiratory Tract Infection	1/171 (0.58%)	0/173 (0.00%)
Septic Shock	1/171 (0.58%)	0/173 (0.00%)
Sinusitis	0/171 (0.00%)	1/173 (0.58%)
Urinary Tract Infection	1/171 (0.58%)	1/173 (0.58%)
Viral Infection	0/171 (0.00%)	1/173 (0.58%)
Viral Upper Respiratory Tract Infection	1/171 (0.58%)	0/173 (0.00%)
Injury, poisoning and procedural complications
Ankle Fracture	1/171 (0.58%)	0/173 (0.00%)
Concussion	0/171 (0.00%)	1/173 (0.58%)
Endotracheal Intubation Complication	1/171 (0.58%)	0/173 (0.00%)
Fall	2/171 (1.17%)	1/173 (0.58%)
Femur Fracture	1/171 (0.58%)	0/173 (0.00%)
Hip Fracture	2/171 (1.17%)	0/173 (0.00%)
Psychosis Postoperative	1/171 (0.58%)	0/173 (0.00%)
Radius Fracture	1/171 (0.58%)	0/173 (0.00%)
Spinal Compression Fracture	1/171 (0.58%)	0/173 (0.00%)
Investigations
Hepatic Enzyme Increased	0/171 (0.00%)	1/173 (0.58%)
Liver Function Test Abnormal	2/171 (1.17%)	0/173 (0.00%)
Weight Decreased	0/171 (0.00%)	1/173 (0.58%)
Metabolism and nutrition disorders
Pelvic Fracture	1/171 (0.58%)	0/173 (0.00%)
Dehydration	1/171 (0.58%)	0/173 (0.00%)
Diabetes Mellitus Inadequate Control	0/171 (0.00%)	1/173 (0.58%)
Hyperkalaemia	1/171 (0.58%)	0/173 (0.00%)
Hypoglycaemia	1/171 (0.58%)	0/173 (0.00%)
Hyponatraemia	1/171 (0.58%)	0/173 (0.00%)
Musculoskeletal and connective tissue disorders
Bursitis	1/171 (0.58%)	0/173 (0.00%)
Intervertebral Disc Protrusion	2/171 (1.17%)	0/173 (0.00%)
Myalgia	1/171 (0.58%)	0/173 (0.00%)
Osteoarthritis	0/171 (0.00%)	1/173 (0.58%)
Pathological Fracture	0/171 (0.00%)	1/173 (0.58%)
Rotator Cuff Syndrome	0/171 (0.00%)	1/173 (0.58%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer	1/171 (0.58%)	1/173 (0.58%)
Bladder Transitional Cell Carcinoma	0/171 (0.00%)	1/173 (0.58%)
Breast Cancer	0/171 (0.00%)	1/173 (0.58%)
Colon Cancer Stage II	1/171 (0.58%)	0/173 (0.00%)
Metastases to Bone	1/171 (0.58%)	0/173 (0.00%)
Metastases to Lung	1/171 (0.58%)	0/173 (0.00%)
Metastastic Neoplasm	0/171 (0.00%)	1/173 (0.58%)
Metastatic Squamous Cell Carcinoma	0/171 (0.00%)	1/173 (0.58%)
Ovarian Cancer	0/171 (0.00%)	1/173 (0.58%)
Pancreatic Carcinoma	1/171 (0.58%)	0/173 (0.00%)
Prostate Cancer	2/171 (1.17%)	0/173 (0.00%)
Small Cell Lung Cancer Stage Unspecified	1/171 (0.58%)	1/173 (0.58%)
Squamous Cell Carcinoma	0/171 (0.00%)	1/173 (0.58%)
Transitional Cell Carcinoma	0/171 (0.00%)	2/173 (1.16%)
Nervous system disorders
Apraxia	0/171 (0.00%)	1/173 (0.58%)
Carotid Artery Stenosis	1/171 (0.58%)	1/173 (0.58%)
Cerebrovascular Accident	1/171 (0.58%)	0/173 (0.00%)
Sciatica	0/171 (0.00%)	1/173 (0.58%)
Transient Ischaemic Attack	0/171 (0.00%)	1/173 (0.58%)
Psychiatric disorders
Mental Status Changes	0/171 (0.00%)	1/173 (0.58%)
Suicidal Ideation	1/171 (0.58%)	0/173 (0.00%)
Renal and urinary disorders
Bladder Neck Obstruction	1/171 (0.58%)	0/173 (0.00%)
Glomerulonephritis Rapidly Progressive	0/171 (0.00%)	1/173 (0.58%)
Mesangioproliferative Glomerulonephritis	0/171 (0.00%)	1/173 (0.58%)
Nephrolithiasis	2/171 (1.17%)	0/173 (0.00%)
Renal Failure Acute	2/171 (1.17%)	2/173 (1.16%)
Reproductive system and breast disorders
Benign Prostatic Hyperpasia	0/171 (0.00%)	1/173 (0.58%)
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure	2/171 (1.17%)	3/173 (1.73%)
Chronic Obstructive Pulmonary Disease	0/171 (0.00%)	1/173 (0.58%)
Dyspnoea	1/171 (0.58%)	1/173 (0.58%)
Haemoptysis	0/171 (0.00%)	1/173 (0.58%)
Hypoxia	0/171 (0.00%)	2/173 (1.16%)
Idiopathic Pulmonary Fibrosis	13/171 (7.60%)	17/173 (9.83%)
Pleural Effusion	1/171 (0.58%)	0/173 (0.00%)
Pneumothorax	1/171 (0.58%)	1/173 (0.58%)
Productive Cough	1/171 (0.58%)	0/173 (0.00%)
Respiratory Arrest	0/171 (0.00%)	1/173 (0.58%)
Respiratory Distress	0/171 (0.00%)	1/173 (0.58%)
Respiratory Failure	4/171 (2.34%)	6/173 (3.47%)
Vascular disorders
Aortic Aneurysm	0/171 (0.00%)	1/173 (0.58%)
Hypertension	0/171 (0.00%)	2/173 (1.16%)
Hypotension	2/171 (1.17%)	1/173 (0.58%)
Malignant Hypertension	1/171 (0.58%)	0/173 (0.00%)
Thrombosis	1/171 (0.58%)	0/173 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Pirfenidone (2403 mg/d)	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	169/171 (98.83%)	170/173 (98.27%)
Metabolism and nutrition disorders
Anorexia †	18/171 (10.53%)	6/173 (3.47%)
Decreased appetite †	13/171 (7.60%)	9/173 (5.20%)
Musculoskeletal and connective tissue disorders
Arthralgia †	16/171 (9.36%)	11/173 (6.36%)
Back Pain †	21/171 (12.28%)	15/173 (8.67%)
Musculoskeletal Pain †	6/171 (3.51%)	9/173 (5.20%)
Pain in Extremity †	11/171 (6.43%)	11/173 (6.36%)
Nervous system disorders
Dizziness †	30/171 (17.54%)	18/173 (10.40%)
Headache †	28/171 (16.37%)	25/173 (14.45%)
Psychiatric disorders
Anxiety †	6/171 (3.51%)	10/173 (5.78%)
Depression †	10/171 (5.85%)	7/173 (4.05%)
Insomnia †	12/171 (7.02%)	11/173 (6.36%)
Respiratory, thoracic and mediastinal disorders
Cough †	51/171 (29.82%)	54/173 (31.21%)
Dyspnoea †	28/171 (16.37%)	34/173 (19.65%)
Idiopathic Pulmonary Fibrosis †	31/171 (18.13%)	40/173 (23.12%)
Nasal Congestion †	12/171 (7.02%)	14/173 (8.09%)
Pharyngolaryngeal pain †	8/171 (4.68%)	11/173 (6.36%)
Postnasal Drip †	7/171 (4.09%)	12/173 (6.94%)
Productive Cough †	11/171 (6.43%)	3/173 (1.73%)
Respiratory Failure †	5/171 (2.92%)	8/173 (4.62%)
Rhinitis Allergic †	11/171 (6.43%)	4/173 (2.31%)
Skin and subcutaneous tissue disorders
Photosensitivity reaction †	17/171 (9.94%)	4/173 (2.31%)
Pruritus †	10/171 (5.85%)	8/173 (4.62%)
Rash †	58/171 (33.92%)	22/173 (12.72%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

 

Results Point of Contact

• Name/Title: Bill Bradford, MD, PhD
• Organization: InterMune, Inc.
• Phone: (415) 466-2200
• EMail: bbradford@intermune.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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. Erratum In: Adv Ther. 2019 Sep 9;:

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.

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.

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.

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.

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.

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.

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.

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• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT00287729
• Other Study ID Numbers: PIPF-006; Capacity 1
• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Results First Submitted: June 2, 2010
• Results First Posted: June 13, 2011
• Last Update Posted: April 17, 2017