Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Brief Summary: The purposes of this study are to assess the efficacy of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis (IPF)and to assess the safety of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis.


Options:
A: Select Inclusion Criteria:

1. Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2011 Guidelines, of 6-48 months' duration
2. Age 40 to 80 at randomization
3. Percent Forced Vital Capacity (%FVC) ≥50% and ≤90% at screening
4. Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30% and ≤90% at screening

Select Exclusion Criteria:

1. Forced expiratory volume in one second (FEV1)/FVC ratio \<0.8 after administration of bronchodilator at Screening
2. Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization
3. Known explanation for interstitial lung disease
4. History of asthma or chronic obstructive pulmonary disease
5. Active infection
6. Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents
7. History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months
B: Inclusion Criteria:

* Ambulant
* Stable medical therapy
* Dyspnoea on exertion following maximal treatment

Exclusion Criteria:

* A history of syncope on exertion
* Too unwell to attend the hospital for exercise training
* Any other comorbidities which would prevent exercise training
* Previous Pulmonary Rehabilitation in the last 12 months
C: Primary Inclusion criteria:

* diagnosis of idiopathic pulmonary fibrosis
* 40 to 80 years of age
* Forced Vital Capacity ≥ 50% predicted value
* carbon monoxide diffusing capacity (DLco) ≥ 35% predicted value
* either Forced Vital Capacity or carbon monoxide diffusing capacity (DLco) ≤ 90% predicted value
* no improvement in past year
* able to walk 150 meters in 6 minutes and maintain saturation ≥ 83% while on no more than 6 liters per minute supplemental oxygen

Primary Exclusion criteria:

* unable to undergo pulmonary function testing
* evidence of significant obstructive lung disease or airway hyper-responsiveness
* in the clinical opinion of the investigator, the patient is expected to need and be eligible for a lung transplant within 72 weeks of 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 syndrome
* other IPF treatment
* unable to take study medication
* withdrawal from other IPF trials
D: Primary Inclusion criteria:

* diagnosis of idiopathic pulmonary fibrosis
* 40 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

Primary Exclusion criteria:

* 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

Answer: C