18 and older, any sex, with Disorder Related to Lung Transplantation or Chronic Lung Allograft Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Percent of Functional Small Airways Disease (fSAD) as Measured by Parametric Response MappingPrimary· Baseline, 24 weeks
Evaluate if pirfenidone compared to placebo will stabilize progression of fSAD by comparison of inspiratory and expiratory high resolution computed tomography (HRCT) images through co-registration to provide quantitative measures of fSAD.
Baseline percentage fSAD
Group
Value
95% CI
Pirfenidone Capsule
14.21
± 8.80
Placebo Capsule
11.90
± 13.08
Post treatment percentage fSAD
Group
Value
95% CI
Pirfenidone Capsule
17.10
± 6.43
Placebo Capsule
10.62
± 9.25
Net change
Group
Value
95% CI
Pirfenidone Capsule
-5.8620625
± 6.636287
Placebo Capsule
0.4497328
± 10.91197
Change in Forced Expiratory Volume 1 Over 24 Weeks (FEV1)Secondary· Baseline, 24 weeks
Measured by spirometry
Baseline FEV1
Group
Value
95% CI
Pirfenidone Capsule
1.40
± 0.59
Placebo Capsule
1.41
± 0.47
24 week FEV1
Group
Value
95% CI
Pirfenidone Capsule
1.36
± 0.57
Placebo Capsule
1.35
± 0.54
Change in FEV1
Group
Value
95% CI
Pirfenidone Capsule
-0.12
± 0.13
Placebo Capsule
-0.09
± 0.30
Change in Forced Vital Capacity (FVC) Over 24 WeeksSecondary· Baseline, 24 weeks
Measured by spirometry
Baseline FVC
Group
Value
95% CI
Pirfenidone Capsule
2.54
± 0.84
Placebo Capsule
2.52
± 0.72
24-week FVC
Group
Value
95% CI
Pirfenidone Capsule
2.52
± 0.87
Placebo Capsule
2.36
± 0.86
Change in FVC
Group
Value
95% CI
Pirfenidone Capsule
-0.06
± 0.25
Placebo Capsule
-0.12
± 0.40
Number of Adverse Events Related to Study TreatmentSecondary· 28 weeks
Safety of pirfenidone will be measured by adverse events determined to be related to the study drug through review of medical history, physical exam and laboratory findings.
AE Definitely Related
Group
Value
95% CI
Pirfenidone Capsule
0
Placebo Capsule
0
AE Probably Related
Group
Value
95% CI
Pirfenidone Capsule
4
Placebo Capsule
0
AE Possibly Related
Group
Value
95% CI
Pirfenidone Capsule
15
Placebo Capsule
10
AE Unlikely to be Related
Group
Value
95% CI
Pirfenidone Capsule
8
Placebo Capsule
10
AE Definitely Not Related
Group
Value
95% CI
Pirfenidone Capsule
1
Placebo Capsule
12
Number of Subjects With Treatment IntoleranceSecondary· 24 weeks
Subjects permanently discontinuing study medication before 24 weeks
Drug Discontinued
Group
Value
95% CI
Pirfenidone Capsule
1
Placebo Capsule
1
Drug Not Discontinued, but Held or Dose Reduced
Group
Value
95% CI
Pirfenidone Capsule
5
Placebo Capsule
3
Drug Tolerated
Group
Value
95% CI
Pirfenidone Capsule
4
Placebo Capsule
6
Adverse events — posted to ClinicalTrials.gov
Time frame: 28 weeks from start of treatment.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Greater than 50% of lung transplant recipients show signs of chronic lung allograft dysfunction (CLAD) by 5 years post-transplantation.Therapies to prevent or slow CLAD are lacking. Anti-fibrotic therapies may offer an avenue to prevent progression of CLAD and prolong allograft survival. This study investigates if Pirfenidone therapy will stabilize lung function decline and slow progression of Functional small airways disease (fSAD) in lung transplant recipients with CLAD.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Michigan
Last refreshed: 17 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03473340.