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Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) (ASCEND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01366209
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : March 12, 2015
Last Update Posted : April 5, 2017
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 555
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Arm Placebo Arm
Hide Arm/Group Description Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day. Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
Period Title: Overall Study
Started 278 277
Completed 243 [1] 241
Not Completed 35 36
Reason Not Completed
Adverse Event             6             7
Withdrawal by Subject             4             4
Death             12             19
Lung transplantation             6             1
Lost to Follow-up             2             1
Physician Decision             1             0
Sponsors decision             0             1
Withdrew consent             4             3
[1]
Participants completing study assessment at Week 52 were completers, even if treatment was withdrawn
Arm/Group Title Active Arm Placebo Arm Total
Hide Arm/Group Description Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day. Placebo: Placebo equivalent given as 3 divided doses 3 times per day. Total of all reporting groups
Overall Number of Baseline Participants 278 277 555
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 278 participants 277 participants 555 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
73
  26.3%
88
  31.8%
161
  29.0%
>=65 years
205
  73.7%
189
  68.2%
394
  71.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 278 participants 277 participants 555 participants
Female
56
  20.1%
64
  23.1%
120
  21.6%
Male
222
  79.9%
213
  76.9%
435
  78.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 278 participants 277 participants 555 participants
United States 187 184 371
Australia 33 31 64
Brazil 15 16 31
Croatia 1 1 2
Israel 11 9 20
Mexico 12 5 17
New Zealand 1 3 4
Peru 18 26 44
Singapore 0 2 2
1.Primary Outcome
Title Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52
Hide Description [Not Specified]
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat all randomized Patient
Arm/Group Title Active Arm Placebo Arm
Hide Arm/Group Description:
Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
Overall Number of Participants Analyzed 278 277
Measure Type: Number
Unit of Measure: percentage of patients
Decline or >=10% or Death 16.5 31.8
No Decline (Change >0%) 22.7 9.7
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Arm Placebo Arm
Hide Arm/Group Description Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day. Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
All-Cause Mortality
Active Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Active Arm Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   55/278 (19.78%)      69/277 (24.91%)    
Blood and lymphatic system disorders     
Thrombocytopenia * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Cardiac disorders     
Acute Myocardial Infarction * 1  1/278 (0.36%)  2 1/277 (0.36%)  1
Angina Pectoris * 1  3/278 (1.08%)  4 0/277 (0.00%)  0
Arrhythmia * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Atrial Fibrillation * 1  1/278 (0.36%)  1 2/277 (0.72%)  2
Atrial Flutter * 1  1/278 (0.36%)  1 1/277 (0.36%)  1
Atrioventricular Block * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Cardiac Arrest * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Cardiac Failure Congestive * 1  2/278 (0.72%)  2 0/277 (0.00%)  0
Cor Pulmonale * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Coronary Artery Occlusion * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Coronary Artery Disease * 1  1/278 (0.36%)  1 1/277 (0.36%)  1
Mitral Valve Incompetence * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Myocardial Infarction * 1  1/278 (0.36%)  1 1/277 (0.36%)  1
Myocardial Ischaemia * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Palpitations * 1  1/278 (0.36%)  1 1/277 (0.36%)  1
Sick Sinus Syndrome * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Tachycardia * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Gastrointestinal disorders     
Abdominal Pain * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Colitis Ulcerative * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Duodenal Ulcer Haemorrhage * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Gastrointestinal Haemorrhage * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Ileus * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Melaena * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Nausea * 1  3/278 (1.08%)  3 0/277 (0.00%)  0
Peptic Ulcer Haemorrhage * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Umbilical Hernia Obstructive * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Volvulus * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Vomiting * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
General disorders     
Non-cardiac chest pain * 1  1/278 (0.36%)  1 1/277 (0.36%)  1
Hepatobiliary disorders     
Hepatitis * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Infections and infestations     
Bronchitis * 1  1/278 (0.36%)  1 2/277 (0.72%)  2
Bronchopneumonia * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Clostridium difficile colitis * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Gastroenteritis viral * 1  0/278 (0.00%)  0 2/277 (0.72%)  2
Influenza * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Lower respiratiory tract infection * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Pneumonia mycoplasmal * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Pneumonia respiratory syncytial viral * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
pneumonia * 1  11/278 (3.96%)  11 14/277 (5.05%)  16
Pulmonary sepsis * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Respiratory syncytial virus infection * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Septic shock * 1  1/278 (0.36%)  1 2/277 (0.72%)  2
Tracheobronchitis * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Urinary tract infection * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Viral upper respiratory tract infection * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle fracture * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Hand fracture * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Hip fracture * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Rib fracture * 1  2/278 (0.72%)  2 0/277 (0.00%)  0
Road traffic accident * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Traumatic brain injury * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Investigations     
Alanine aminotransferase increased * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Aspartate aminotransferase increased * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Weight decreased * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  1/278 (0.36%)  1 1/277 (0.36%)  1
Diabetes Mellitus * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Failure to thrive * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Hyponatraemia * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Musculoskeletal and connective tissue disorders     
Arthritis * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Cervical spinal stenosis * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Intervertebral disc degeneration * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Intervertebral disc protrusion * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Musculoskeletal chest pain * 1  1/278 (0.36%)  1 1/277 (0.36%)  1
Osteoarthritis * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Pain in jaw * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Rotator cuff syndrome * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer in situ * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Breast cancer * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Gastric cancer * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Hepatic neoplasm malignant * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Hypopharyngeal cancer * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Prostate cancer * 1  2/278 (0.72%)  2 4/277 (1.44%)  4
Nervous system disorders     
Cerebrovascular Accident * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Haemorrhage intercranial * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Haemorrhagic stroke * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Ischaemic stroke * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
IVth nerve paralysis * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Loss of consciousness * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Spinal cord compression * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Syncope * 1  1/278 (0.36%)  1 1/277 (0.36%)  1
Psychiatric disorders     
Completed suicide * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Psychotic disorder * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Renal and urinary disorders     
Renal failure acute * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Renal failure * 1  1/278 (0.36%)  1 1/277 (0.36%)  1
Urethral pain * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Urinary retention * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure * 1  1/278 (0.36%)  1 1/277 (0.36%)  1
Cough * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Dyspnoea * 1  1/278 (0.36%)  1 2/277 (0.72%)  2
Hypoxia * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Idiopathic pulmonary fibrosis * 1  7/278 (2.52%)  11 27/277 (9.75%)  32
Interstitial lung disease * 1  1/278 (0.36%)  1 0/277 (0.00%)  0
Pneumothorax spontaneous tension * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Pneumothorax * 1  1/278 (0.36%)  1 1/277 (0.36%)  1
Pulmonary alveolar haemorrhage * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Pulmonary embolism * 1  1/278 (0.36%)  1 2/277 (0.72%)  2
Respiratory failure * 1  1/278 (0.36%)  1 1/277 (0.36%)  1
Pulmonary Hypertension * 1  1/278 (0.36%)  1/277 (0.36%) 
Vascular disorders     
Aortic aneurysm * 1  0/278 (0.00%)  0 2/277 (0.72%)  2
Deep vein thrombosis * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
Hypotension * 1  0/278 (0.00%)  0 1/277 (0.36%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active Arm Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   271/278 (97.48%)      253/277 (91.34%)    
Gastrointestinal disorders     
Abdominal pain upper * 1  20/278 (7.19%)  33 12/277 (4.33%)  14
Constipation * 1  32/278 (11.51%)  38 38/277 (13.72%)  39
Diarrhoea * 1  62/278 (22.30%)  112 60/277 (21.66%)  101
Dyspepsia * 1  49/278 (17.63%)  61 17/277 (6.14%)  22
Flatulence * 1  12/278 (4.32%)  13 17/277 (6.14%)  18
Gastrooesophageal Reflux * 1  33/278 (11.87%)  36 18/277 (6.50%)  21
Nausea * 1  100/278 (35.97%)  138 37/277 (13.36%)  46
Stomach Discomfort * 1  24/278 (8.63%)  38 12/277 (4.33%)  15
Vomiting * 1  36/278 (12.95%)  74 24/277 (8.66%)  28
General disorders     
Asthenia * 1  16/278 (5.76%)  17 11/277 (3.97%)  12
Oedema peripheral * 1  9/278 (3.24%)  9 23/277 (8.30%)  24
Pyrexia * 1  6/278 (2.16%)  7 17/277 (6.14%)  20
Fatigue * 1  58/278 (20.86%)  93 48/277 (17.33%)  55
Infections and infestations     
Bronchitis * 1  38/278 (13.67%)  50 34/277 (12.27%)  49
Influenza * 1  14/278 (5.04%)  16 12/277 (4.33%)  12
Lower respiratory tract infection * 1  11/278 (3.96%)  13 19/277 (6.86%)  23
Nasopharyngitis * 1  33/278 (11.87%)  45 30/277 (10.83%)  40
Sinusitis * 1  20/278 (7.19%)  25 24/277 (8.66%)  32
Upper respiratory tract infection * 1  61/278 (21.94%)  78 56/277 (20.22%)  79
Urinary tract infection * 1  8/278 (2.88%)  12 17/277 (6.14%)  28
Investigations     
Weight decreased * 1  35/278 (12.59%)  35 22/277 (7.94%)  23
Metabolism and nutrition disorders     
Anorexia * 1  44/278 (15.83%)  47 18/277 (6.50%)  19
Decreased appetite * 1  20/278 (7.19%)  23 10/277 (3.61%)  10
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  26/278 (9.35%)  36 20/277 (7.22%)  33
Back pain * 1  30/278 (10.79%)  35 37/277 (13.36%)  42
Musculoskeletal pain * 1  14/278 (5.04%)  14 9/277 (3.25%)  11
Pain in extremity * 1  14/278 (5.04%)  18 16/277 (5.78%)  18
Nervous system disorders     
Dizziness * 1  49/278 (17.63%)  88 36/277 (13.00%)  43
Dysgeusia * 1  25/278 (8.99%)  26 11/277 (3.97%)  12
Headache * 1  72/278 (25.90%)  117 64/277 (23.10%)  96
Psychiatric disorders     
Anxiety * 1  8/278 (2.88%)  8 14/277 (5.05%)  14
Depression * 1  9/278 (3.24%)  9 14/277 (5.05%)  14
Insomnia * 1  31/278 (11.15%)  33 18/277 (6.50%)  21
Respiratory, thoracic and mediastinal disorders     
Cough * 1  70/278 (25.18%)  104 82/277 (29.60%)  97
Dyspnoea * 1  41/278 (14.75%)  49 49/277 (17.69%)  66
Idiopathic pulmonary fibrosis * 1  19/278 (6.83%)  21 32/277 (11.55%)  43
Pharyngolaryngeal pain * 1  14/278 (5.04%)  14 20/277 (7.22%)  21
Productive cough * 1  9/278 (3.24%)  11 14/277 (5.05%)  14
Skin and subcutaneous tissue disorders     
Photosensitivity reaction * 1  16/278 (5.76%)  25 1/277 (0.36%)  1
Pruritis * 1  27/278 (9.71%)  35 19/277 (6.86%)  20
Rash * 1  78/278 (28.06%)  123 24/277 (8.66%)  27
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01366209     History of Changes
Other Study ID Numbers: PIPF-016
First Submitted: June 2, 2011
First Posted: June 3, 2011
Results First Submitted: February 27, 2015
Results First Posted: March 12, 2015
Last Update Posted: April 5, 2017