Fernando J. Martinez, MD, MS, prepared useful Practice Aids pertaining to interstitial lung diseases for this CME activity titled "Evaluating New Advances in Idiopathic Pulmonary Fibrosis and Other Interstitial Lung Diseases: Updates From San Diego." For the full presentation, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/2l5SmFr. CME credit will be available until June 26, 2019.

1. Access the activity, “Evaluating New Advances in Idiopathic Pulmonary
Fibrosis and Other Interstitial Lung Diseases: Updates From San Diego,”
at www.peerview.com/FBJ40.
Clinical Trials in Interstitial
Lung Diseases
PRACTICE AID
This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients.
FEV1
: forced expiratory volume in 1 second; FVC: forced vital capacity; RAILD: rheumatoid arthritis–associated interstitial lung disease.
1. https://clinicaltrials.gov/ct2/show/NCT03062943. Accessed June 7, 2018. 2. https://clinicaltrials.gov/ct2/show/NCT02999178. Accessed June 7, 2018. 3. https://clinicaltrials.gov/ct2/show/NCT02808871.
Accessed June 7, 2018. 4. https://clinicaltrials.gov/ct2/show/NCT02958917. Accessed June 7, 2018. 5. https://clinicaltrials.gov/ct2/show/NCT03099187. Accessed June 7, 2018.
Nintedanib
Pirfenidone
• Recruiting
• Phase 2, open-label trial
• Primary outcome: Annual rate of FEV1
decline
A Study of Nintedanib for LymphAngioleioMyomatosis (LAM)1
• Recruiting
• Phase 2, randomized, double-blind, placebo-controlled trial
• Primary outcome: Incidence of the composite endpoint of decline in percent predicted FVC
of ≥10% or death
Phase 2 Study of Pirfenidone in Patients With RAILD3
• Recruiting
• Randomized, double-blind, placebo-controlled study
• Primary outcome: Annual mean change from baseline in percent FVC
Study of Efficacy and Safety of Pirfenidone in Patients With Fibrotic Hypersensitivity Pneumonitis4
• Recruiting
• Phase 2, multicenter, international, double-blind, two-arm, randomized, placebo-controlled trial
• Primary outcome: Rate of FVC decline over the 24-week double-blind treatment period
A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease5
• Active, not recruiting
• Phase 3, double-blind, randomized, placebo-controlled trial
• Primary outcome: Annual rate of FEV1
decline
Efficacy and Safety of Nintedanib in Patients With Progressive
Fibrosing Interstitial Lung Disease (PF-ILD)2

2. Antifibrotic Therapy in
Scleroderma-Related Interstitial
Lung Disease
FVC: forced vital capacity.
1. https://clinicaltrials.gov/ct2/show/NCT02597933. Accessed June 7, 2018.
2. https://clinicaltrials.gov/ct2/show/NCT03313180. Accessed June 7, 2018.
3. https://clinicaltrials.gov/ct2/show/NCT03221257. Accessed June 7, 2018.
PRACTICE AID
Access the activity, “Evaluating New Advances in Idiopathic Pulmonary
Fibrosis and Other Interstitial Lung Diseases: Updates From San Diego,”
at www.peerview.com/FBJ40.
This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients.
Nintedanib
Pirfenidone
• Active, not recruiting
• Phase 3, double-blind, randomized, placebo-controlled trial
• Primary outcome: Annual rate of FVC decline
• Recruiting
• Phase 2, multicenter, double-blind, parallel-group, randomized and placebo-controlled trial
• Primary outcome: Percent predicted FVC
• Recruiting
• Phase 3, open-label extension trial
• Primary outcome: Incidence of overall adverse events
A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis1
Scleroderma Lung Study III – Combining Pirfenidone With Mycophenolate (SLSIII)3
A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in
Patients With Scleroderma Related Lung Fibrosis2

3. Combination Therapy Trials in
Idiopathic Pulmonary Fibrosis
PRACTICE AID
6MWD: 6-minute walking distance; SGRQ: St. George's Respiratory Questionnaire
1. https://clinicaltrials.gov/ct2/show/NCT02802345. Accessed June 7, 2018.
2. https://clinicaltrials.gov/ct2/show/NCT02951429. Accessed June 7, 2018.
Access the activity, “Evaluating New Advances in Idiopathic Pulmonary
Fibrosis and Other Interstitial Lung Diseases: Updates From San Diego,”
at www.peerview.com/FBJ40.
This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients.
Nintedanib + Sildenafil
Pirfenidone + Sildenafil
• Completed
• Phase 3, double-blind, randomized, parallel-group study
• Primary outcome: Change from baseline in SGRQ total score at week 12
• Recruiting
• Phase IIb, multicenter, randomized, double-blind, placebo-controlled study
• Primary outcome: Annual percentage of participants with disease progression, as determined
by relevant decline in 6MWD of at least ≥15% from baseline, respiratory-related non-elective
hospitalization, or death from any cause
Efficacy and Safety of Nintedanib When Co-administered With Sildenafil in Idiopathic
Pulmonary Fibrosis Patients With Advanced Lung Function Impairment1
Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil
in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Risk of Group 3
Pulmonary Hypertension2