Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT00287716

Recruitment Status : Completed

First Posted : February 7, 2006

Results First Posted : June 13, 2011

Last Update Posted : May 22, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

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	435

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Pirfenidone 2403 mg/Day	Pirfenidone 1197 mg/Day	Placebo
Arm/Group Description	pirfenidone, total daily dose of 24...	pirfenidone, total daily dose of 11...	placebo equivalent, given as 3 divi...
Arm/Group Description	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	pirfenidone, total daily dose of 1197 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	174	87	174
Completed	136	70	143
Not Completed	38	17	31

Baseline Characteristics

Arm/Group Title		Pirfenidone 2403 mg/Day	Pirfenidone 1197 mg/Day	Placebo	Total
Arm/Group Description		pirfenidone, total daily dose of 24...	pirfenidone, total daily dose of 11...	placebo equivalent, given as 3 divi...	Total of all reporting groups
Arm/Group Description		pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	pirfenidone, total daily dose of 1197 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		174	87	174	435
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	174 participants	87 participants	174 participants	435 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	75 43.1%	28 32.2%	73 42.0%	176 40.5%
	>=65 years	99 56.9%	59 67.8%	101 58.0%	259 59.5%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	174 participants	87 participants	174 participants	435 participants
		65.7 (8.15)	68 (7.63)	66.3 (7.53)	66.4 (7.83)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	174 participants	87 participants	174 participants	435 participants
	Female	56 32.2%	22 25.3%	46 26.4%	124 28.5%
	Male	118 67.8%	65 74.7%	128 73.6%	311 71.5%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	174 participants	87 participants	174 participants	435 participants
United States		114	58	114	286
Europe		34	18	38	90
Mexico		2	0	1	3
Canada		21	8	18	47
Australia		3	3	3	9

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 measur...
Description	Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72.
Time Frame	From baseline up to 72 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Pirfenidone 2403 mg/Day	Pirfenidone 1197 mg/Day	Placebo
Arm/Group Description:	pirfenidone, total daily dose of 24...	pirfenidone, total daily dose of 11...	placebo equivalent, given as 3 divi...
Arm/Group Description:	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	pirfenidone, total daily dose of 1197 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	174	87	174
Mean (Standard Deviation) Unit of Measure: Change in Percent Predicted FVC
	-8.0 (16.47)	-10.0 (16.68)	-12.4 (18.45)

2.Secondary Outcome


Title	Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC)
Description	Based on the change in baseline percent predicted FVC at week 72, pati...
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 experienced a Categorical Change in Percent Predicted Forced Vital Capacity.
Time Frame	baseline up to 72 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Pirfenidone 2403 mg/Day	Pirfenidone 1197 mg/Day	Placebo
Arm/Group Description:	pirfenidone, total daily dose of 24...	pirfenidone, total daily dose of 11...	placebo equivalent, given as 3 divi...
Arm/Group Description:	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	pirfenidone, total daily dose of 1197 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	174	87	174
Measure Type: Number Unit of Measure: Patients
Severe decline of >=20%, death, or lung transplant	14	9	27
Moderate decline of <20% but >=10%	21	14	33
Mild decline of <10% but >=0%	97	51	90
Mild improvement of >0% but <10%	40	12	24
Moderate improvement of >=10%	2	1	0

3.Secondary Outcome


Title	Progression-free Survival (PFS)
Description	Progression is defined as the first occurrence of a 10% absolute decli...
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

[Not Specified]


Arm/Group Title	Pirfenidone 2403 mg/Day	Pirfenidone 1197 mg/Day	Placebo
Arm/Group Description:	pirfenidone, total daily dose of 24...	pirfenidone, total daily dose of 11...	placebo equivalent, given as 3 divi...
Arm/Group Description:	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	pirfenidone, total daily dose of 1197 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	174	87	174
Measure Type: Number Unit of Measure: Number of Patients with Progression
Death or Disease Progression	45	28	62
Decline in Percent Predicted FVC >=10%	28	16	39
Decline in Percent Predicted DLco >=15%	9	5	9
Death Before Disease Progression	8	7	14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pirfenidone 2403 mg/Day, Placebo
	Comments	The null hypothesis is that there is no treatment difference between the pirfenidone 2403 mg/day treatment group and the placebo treatment group.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.023
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 95% 0.44 to 0.95
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Change in Six-Minute Walk Test (6MWT)Distance
Description	The change from Baseline to week 72 in distance walked during the 6-Mi...
Description	The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test as measured in meters (m).
Time Frame	Baseline to Week 72

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Pirfenidone 2403 mg/Day	Pirfenidone 1197 mg/Day	Placebo
Arm/Group Description:	pirfenidone, total daily dose of 24...	pirfenidone, total daily dose of 11...	placebo equivalent, given as 3 divi...
Arm/Group Description:	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	pirfenidone, total daily dose of 1197 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	174	87	174
Mean (Standard Deviation) Unit of Measure: Change in Distance Walked in Meters
	-60 (121)	-76 (132)	-77 (135)

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 ...
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 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

[Not Specified]


Arm/Group Title	Pirfenidone 2403 mg/Day	Pirfenidone 1197 mg/Day	Placebo
Arm/Group Description:	pirfenidone, total daily dose of 24...	pirfenidone, total daily dose of 11...	placebo equivalent, given as 3 divi...
Arm/Group Description:	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	pirfenidone, total daily dose of 1197 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	174	87	174
Mean (Standard Deviation) Unit of Measure: Change,Worst Oxygen Saturation (Percent)
	-2 (4)	-1 (5)	-2 (5)

6.Secondary Outcome


Title	Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline to Week 72

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Pirfenidone 2403 mg/Day	Pirfenidone 1197 mg/Day	Placebo
Arm/Group Description:	pirfenidone, total daily dose of 24...	pirfenidone, total daily dose of 11...	placebo equivalent, given as 3 divi...
Arm/Group Description:	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	pirfenidone, total daily dose of 1197 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	174	87	174
Mean (Standard Deviation) Unit of Measure: Change in Percent Predicted DLco
	-8 (10)	-9 (11)	-10 (12)

7.Secondary Outcome


Title	Change in Dyspnea Score
Description	The mean change from baseline to week 72 in Dyspnea score was measured...
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

[Not Specified]


Arm/Group Title	Pirfenidone 2403 mg/Day	Pirfenidone 1197 mg/Day	Placebo
Arm/Group Description:	pirfenidone, total daily dose of 24...	pirfenidone, total daily dose of 11...	placebo equivalent, given as 3 divi...
Arm/Group Description:	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	pirfenidone, total daily dose of 1197 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	174	87	174
Mean (Standard Deviation) Unit of Measure: Change in Dyspnea Score
	12 (24)	14 (25)	15 (26)

8.Secondary Outcome


Title	Worsening of Idiopathic Pulmonary Fibrosis (IPF)
Description	Worsening of IPF was defined by the occurrence of any of the following...
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

[Not Specified]


Arm/Group Title	Pirfenidone 2403 mg/Day	Pirfenidone 1197 mg/Day	Placebo
Arm/Group Description:	pirfenidone, total daily dose of 24...	pirfenidone, total daily dose of 11...	placebo equivalent, given as 3 divi...
Arm/Group Description:	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day	pirfenidone, total daily dose of 1197 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	174	87	174
Measure Type: Number Unit of Measure: Number of Patients Who Worsened
	26	10	30

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pirfenidone 2403 mg/Day, Placebo
	Comments	The null hypothesis is that there is no treatment difference between the pirfenidone 2403-mg/d treatment group and the placebo treatment group.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.515
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95% 0.50 to 1.42
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Pirfenidone 2403 mg/Day		Pirfenidone 1197 mg/Day		Placebo
Arm/Group Description	pirfenidone, total daily dose of 24...		pirfenidone, total daily dose of 11...		placebo equivalent, given as 3 divi...
Arm/Group Description	pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day		pirfenidone, total daily dose of 1197 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/Day		Pirfenidone 1197 mg/Day		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events Serious Adverse Events
	Pirfenidone 2403 mg/Day		Pirfenidone 1197 mg/Day		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	60/174 (34.48%)		28/87 (32.18%)		58/174 (33.33%)
Blood and lymphatic system disorders
Anaemia	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Bone Marrow Failure	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Disseminated Intravascular Coagulation	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Haemorrhagic Disorder	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Cardiac disorders
Acute Myocardial Infarction	1/174 (0.57%)		0/87 (0.00%)		1/174 (0.57%)
Angina Pectoris	2/174 (1.15%)		2/87 (2.30%)		1/174 (0.57%)
Arteriosclerosis Coronary Artery	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Atrial Fibrillation	1/174 (0.57%)		3/87 (3.45%)		1/174 (0.57%)
Atrial Flutter	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Atrioventricular Block Complete	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Atrioventricular Block Second Degree	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Cardiac Failure Congestive	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
COR Pulmonale Acute	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Coronary Artery Disease	0/174 (0.00%)		3/87 (3.45%)		2/174 (1.15%)
Coronary Artery Occlusion	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Hypertrophic Cardiomyopathy	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Myocardial Infarction	0/174 (0.00%)		2/87 (2.30%)		4/174 (2.30%)
Myocardial Ischaemia	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Palpitations	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Right Ventricular Failure	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Tachycardia	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Ventricular Arrhythmia	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Ear and labyrinth disorders
Vertigo	1/174 (0.57%)		1/87 (1.15%)		0/174 (0.00%)
Endocrine disorders
Adrenal Insufficiency	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Eye disorders
Eye Haemorrhage	0/174 (0.00%)		1/87 (1.15%)		1/174 (0.57%)
Maculopathy	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Retinal Vein Occulusion	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Gastrointestinal disorders
Abdominal Compartment Syndrome	0/174 (0.00%)		0/87 (0.00%)		0/174 (0.00%)
Abdominal Pain Upper	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Colitis	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Colonic Obstruction	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Colonic Polyp	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Diarrhoea	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Diverticulum	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Erosive Duodenitis	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Gastrointestinal Haemorrhage	0/174 (0.00%)		1/87 (1.15%)		1/174 (0.57%)
Gastrooesophageal Reflux Disease	2/174 (1.15%)		0/87 (0.00%)		0/174 (0.00%)
Haemorrhoids	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Ileitis	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Internal Hernia	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Intestinal Obstruction	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Large Intestinal Haemorrhage	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Localised Intraabdominal Fluid Correction	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Megacolon	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Oesophagitis	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Pancreatitis Acute	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Peritoneal Haemorrhage	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Umbilical Hernia	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Volvulus	0/174 (0.00%)		1/87 (1.15%)		1/174 (0.57%)
General disorders
Chest Pain	5/174 (2.87%)		3/87 (3.45%)		3/174 (1.72%)
Fatigue	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Impaired Healing	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Non-Cardiac Chest Pain	2/174 (1.15%)		0/87 (0.00%)		2/174 (1.15%)
Oedema Peripheral	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Vestibulitis	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Hepatobiliary disorders
Cholecystitis	1/174 (0.57%)		0/87 (0.00%)		2/174 (1.15%)
Cholecystitis Acute	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Cholelithiasis	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Infections and infestations
Abdominal Wall Infection	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Appendicitis	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Bronchitis	2/174 (1.15%)		2/87 (2.30%)		2/174 (1.15%)
Cellulitis	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Clostridium Difficile Colitis	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Diverticulitis	0/174 (0.00%)		1/87 (1.15%)		1/174 (0.57%)
Empyema	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Gastroenteritis	0/174 (0.00%)		0/87 (0.00%)		2/174 (1.15%)
Influenza	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Lobar Pneumonia	2/174 (1.15%)		2/87 (2.30%)		2/174 (1.15%)
Lower Respiratory Tract Infection	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Lower Respiratory Tract Infection Viral	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Orchitis	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Perianal Abscess	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Pneumonia	4/174 (2.30%)		3/87 (3.45%)		6/174 (3.45%)
Pneumonia Primary Atypical	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Post Procedural Infection	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Respiratory Tract Infection	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Septic Shock	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Sinusitis	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Staphylococcal Infection	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Tracheitis	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Tracheobronchitis	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Urinary Tract Infection Bacterial	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Urinary Tract Infection Fungal	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Vulval Abscess	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Injury, poisoning and procedural complications
Burns First Degree	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Burns Second Degree	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Fall	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Muscle Rupture	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Post Procedural Myocardial Infarction	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Investigations
Blood Amylase Increased	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Gamma-Glutamyltransferase Increasesd	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Liver Function Test Abnormal	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Metabolism and nutrition disorders
Fluid Overload	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Hyperkalaemia	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Back Pain	1/174 (0.57%)		1/87 (1.15%)		0/174 (0.00%)
Osteoporotic Fracture	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Pain in Extremity	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Rheumatoid Arthritis	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Pancreas	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Bile Duct Cancer	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Bladder Cancer	2/174 (1.15%)		0/87 (0.00%)		0/174 (0.00%)
Bladder Neoplasm	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Breast Cancer	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Colon Cancer	1/174 (0.57%)		1/87 (1.15%)		1/174 (0.57%)
Lung Adenocarcinoma Metastatic	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Lung Cancer Metastatic	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Metastases to Lung	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Ovarian Cancer Metastatic	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Prostate Cancer	0/174 (0.00%)		1/87 (1.15%)		2/174 (1.15%)
Rectal Cancer	0/174 (0.00%)		2/87 (2.30%)		0/174 (0.00%)
Small Cell Lung Cancer Metastatic	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Small Cell Lung Cancer Stage Unspecified	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Tonsil Cancer	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Nervous system disorders
Anoxic Encephalopathy	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
carotid Artery Stenosis	0/174 (0.00%)		1/87 (1.15%)		1/174 (0.57%)
Cerebral Artery Occlusion	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Cerebrovascular Accident	1/174 (0.57%)		0/87 (0.00%)		1/174 (0.57%)
Hemiparesis	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Migraine with Aura	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Presyncope	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Syncope	3/174 (1.72%)		1/87 (1.15%)		1/174 (0.57%)
Thrombotic Stroke	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Transient Ischaemic Attack	1/174 (0.57%)		0/87 (0.00%)		1/174 (0.57%)
Psychiatric disorders
Depression	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Suicidal Ideation	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Renal and urinary disorders
Calculus Urinary	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Renal Failure Acute	1/174 (0.57%)		2/87 (2.30%)		0/174 (0.00%)
Renal Failure Chronic	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Stress Urinary Incontinence	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Urethral Disorder	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Urinary Retention	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Reproductive system and breast disorders
Benign Prostatic Hyperplasia	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Cystocele	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Prostatitis	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Acute Respiratory Failure	2/174 (1.15%)		0/87 (0.00%)		3/174 (1.72%)
Cough	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Dyspnoea	0/174 (0.00%)		1/87 (1.15%)		3/174 (1.72%)
Haemoptysis	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Hypoxia	1/174 (0.57%)		0/87 (0.00%)		2/174 (1.15%)
Idiopathic Pulmonary Fibrosis	13/174 (7.47%)		5/87 (5.75%)		14/174 (8.05%)
Pleural Effusion	1/174 (0.57%)		1/87 (1.15%)		0/174 (0.00%)
Pneumonia Aspiration	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Pneumonitis	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Pneumothorax	3/174 (1.72%)		2/87 (2.30%)		0/174 (0.00%)
Pulmonary Embolism	1/174 (0.57%)		3/87 (3.45%)		1/174 (0.57%)
Pulmonary Haemorrhage	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Respiratory Distress	0/174 (0.00%)		0/87 (0.00%)		1/174 (0.57%)
Respiratory Failure	2/174 (1.15%)		3/87 (3.45%)		2/174 (1.15%)
Skin and subcutaneous tissue disorders
Lichen Sclerosus	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Photosensitivity Reaction	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Rash	1/174 (0.57%)		0/87 (0.00%)		0/174 (0.00%)
Vascular disorders
Aortic Aneurysm	2/174 (1.15%)		1/87 (1.15%)		0/174 (0.00%)
Hypertension	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Orthostatic Hypertension	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Shock Haemorrhagic	0/174 (0.00%)		1/87 (1.15%)		0/174 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Pirfenidone 2403 mg/Day		Pirfenidone 1197 mg/Day		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	171/174 (98.28%)		86/87 (98.85%)		169/174 (97.13%)
Gastrointestinal disorders
Abdominal distension ^†	15/174 (8.62%)	16	3/87 (3.45%)	3	12/174 (6.90%)	14
Abdominal pain ^†	16/174 (9.20%)	18	6/87 (6.90%)	7	7/174 (4.02%)	10
Asthenia ^†	15/174 (8.62%)	18	10/87 (11.49%)	11	5/174 (2.87%)	5
Dyspepsia ^†	30/174 (17.24%)	34	12/87 (13.79%)	17	16/174 (9.20%)	34
Nausea ^†	60/174 (34.48%)	96	22/87 (25.29%)	27	32/174 (18.39%)	37
Stomach discomfort ^†	14/174 (8.05%)	16	4/87 (4.60%)	5	4/174 (2.30%)	4
Vomiting ^†	24/174 (13.79%)	34	11/87 (12.64%)	14	7/174 (4.02%)	9
Investigations
Weight decreased ^†	15/174 (8.62%)	15	8/87 (9.20%)	8	7/174 (4.02%)	8
Metabolism and nutrition disorders
Anorexia ^†	19/174 (10.92%)	20	9/87 (10.34%)	11	7/174 (4.02%)	7
Decreased appetite ^†	17/174 (9.77%)	18	3/87 (3.45%)	3	1/174 (0.57%)	1
Musculoskeletal and connective tissue disorders
Arthralgia ^†	20/174 (11.49%)	28	9/87 (10.34%)	10	13/174 (7.47%)	15
Nervous system disorders
Dizziness ^†	33/174 (18.97%)	42	14/87 (16.09%)	18	17/174 (9.77%)	19
Psychiatric disorders
Insomnia ^†	22/174 (12.64%)	27	13/87 (14.94%)	14	12/174 (6.90%)	13
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain ^†	16/174 (9.20%)	20	2/87 (2.30%)	2	5/174 (2.87%)	9
Skin and subcutaneous tissue disorders
Photosensitivity reaction ^†	25/174 (14.37%)	40	6/87 (6.90%)	6	2/174 (1.15%)	4
Pruritus ^†	12/174 (6.90%)	15	5/87 (5.75%)	8	6/174 (3.45%)	8
Rash ^†	53/174 (30.46%)	75	15/87 (17.24%)	27	18/174 (10.34%)	25
Vascular disorders
Hot flush ^†	11/174 (6.32%)	11	3/87 (3.45%)	3	2/174 (1.15%)	3
† 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

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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.

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.

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.

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.

Layout table for additonal information

Responsible Party:	Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00287716
Other Study ID Numbers:	PIPF-004 Capacity 2
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:	May 22, 2017

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