Trial · NCT03099187
A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease
NCT03099187, Phase 2, Completed, Hoffmann-La Roche; results first posted 2020-01-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease. Trials, record NCT03099187. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03099187
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease
- NCT number
- NCT03099187
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 253 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Lung Diseases, Interstitial
- Interventions
- Pirfenidone, Placebo
- First posted
- 2017-04-04
- Last updated
- 2021-01-13
- Other registries' IDs
- eudract:2016-002744-17
- Results first posted
- 2020-01-03
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Decline in Forced Vital Capacity (FVC) Over the 24-week Double-blind Treatment Period | Up to Week 24 | Rate of decline in FVC was measured in mL by daily handheld spirometer. The analyses were repeated due to an additional independent review of the home spirometry data. |
| Secondary | Change in Percent Predicted FVC | Baseline (Day 1) to Week 24 | FVC was measured in liter (L) by spirometry. The analyses were repeated due to additional data cleaning activities that were not conducted during the primary analysis. |
| Secondary | Change in FVC | Baseline (Day 1) to Week 24 | FVC was measured in liter (L) by spirometry. The analyses were repeated due to additional data cleaning activities that were not conducted during the primary analysis. |
| Secondary | Categorical Change in FVC of >5% | Baseline (Day 1) to Week 24 | Categorical change in FVC was measured both by daily spirometry as well as by spirometry during clinical visits. Only the site spirometry data were used as the daily spirometry data were not normally distributed. The analyses were repeated due to additional data cleaning activities that were not conducted during the primary analysis. |
| Secondary | Categorical Change in FVC of >10% | Baseline (Day 1) to Week 24 | Categorical change in FVC was measured both by daily spirometry as well as by spirometry during clinical visits. Only the site spirometry data were used as the daily spirometry data were not normally distributed. The analyses were repeated due to additional data cleaning activities that were not conducted during the primary analysis. |
| Secondary | Change in Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLco) | Baseline (Day 1) to Week 24 | The DLco is a pulmonary function test that measures the capacity for the lung to carry out gas exchange between the inhaled breath and the pulmonary capillary blood vessels and the DLco %-predicted represents the DLco expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity. |
| Secondary | Change in 6-minute Walk Distance (6MWD) | Baseline (Day 1) to Week 24 | Comparison of 6-minute walk distance before beginning and after completing study therapy. |
| Secondary | Change in University of California, San Diego-Shortness of Breath Questionnaire Score | Baseline (Day 1) to Week 24 | University of California, San Diego Shortness of Breath Questionnaire (SOBQ) consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores were calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life. |
| Secondary | Change in Score in Leicester Cough Questionnaire Score | Baseline (Day 1) to Week 24 | The Leicester Cough Questionnaire is a patient-reported questionnaire evaluating the impact of cough on quality of life. The questionnaire comprises 19 items. Each item assesses symptoms, or the impact of symptoms, over the last 2 weeks on a seven-point Likert scale. Scores in three domains (physical, psychological and social) were calculated as a mean for each domain (range 1 to 7). A total score (range 3 to 21) was also calculated by adding the domain scores together. Higher scores indicate better quality of life. |
| Secondary | Change in Cough Visual Analog Scale (VAS) Score | Baseline (Day 1) to Week 24 | Cough VAS are 100-mm linear scales on which participants indicate the severity of their cough; 0 mm represents no cough and 100 mm the worst cough ever. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Decline in Forced Vital Capacity (FVC) Over the 24-week Double-blind Treatment Period | Up to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | milliliter (mL) | MEAN |
| SECONDARY | Change in Percent Predicted FVC | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | Percent predicted (%) | MEAN |
| SECONDARY | Change in FVC | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | Liter (L) | MEAN |
| SECONDARY | Categorical Change in FVC of >5% | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. | Number of Participants | NUMBER |
| SECONDARY | Categorical Change in FVC of >10% | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. | Number of Participants | NUMBER |
| SECONDARY | Change in Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLco) | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | % predicted | MEAN |
| SECONDARY | Change in 6-minute Walk Distance (6MWD) | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | meter (m) | MEAN |
| SECONDARY | Change in University of California, San Diego-Shortness of Breath Questionnaire Score | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | Scores on a Scale | MEAN |
| SECONDARY | Change in Score in Leicester Cough Questionnaire Score | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | Scores on a Scale | MEAN |
| SECONDARY | Change in Cough Visual Analog Scale (VAS) Score | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | millimeter (mm) | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group132
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Decline in Forced Vital Capacity (FVC) Over the 24-week Double-blind Treatment Period | Pirfenidone | Primary Analysis in 2019 | -17.9 | 95% Confidence Interval -311.7 to 275.9 | milliliter (mL) |
| Rate of Decline in Forced Vital Capacity (FVC) Over the 24-week Double-blind Treatment Period | Placebo | Primary Analysis in 2019 | 116.6 | 95% Confidence Interval -451.9 to 685.2 | milliliter (mL) |
| Rate of Decline in Forced Vital Capacity (FVC) Over the 24-week Double-blind Treatment Period | Pirfenidone | Final Analysis in 2020 | -90.3 | 95% Confidence Interval -157.0 to -23.7 | milliliter (mL) |
| Rate of Decline in Forced Vital Capacity (FVC) Over the 24-week Double-blind Treatment Period | Placebo | Final Analysis in 2020 | 125.6 | 95% Confidence Interval -458.4 to 709.6 | milliliter (mL) |
| Change in Percent Predicted FVC | Pirfenidone | Baseline (Day 1) | 73.95 | Standard Deviation 18.815 | Percent predicted (%) |
| Change in Percent Predicted FVC | Placebo | Baseline (Day 1) | 73.95 | Standard Deviation 19.974 | Percent predicted (%) |
| Change in Percent Predicted FVC | Pirfenidone | Week 4 | 74.04 | Standard Deviation 19.009 | Percent predicted (%) |
| Change in Percent Predicted FVC | Placebo | Week 4 | 74.55 | Standard Deviation 21.223 | Percent predicted (%) |
| Change in Percent Predicted FVC | Pirfenidone | Week 8 | 73.98 | Standard Deviation 19.324 | Percent predicted (%) |
| Change in Percent Predicted FVC | Placebo | Week 8 | 73.50 | Standard Deviation 20.168 | Percent predicted (%) |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Treatment | STARTED | Pirfenidone | 127 | |
| Double-blind Treatment | STARTED | Placebo | 126 | |
| Double-blind Treatment | STARTED | Open-Label Treatment (Pirfenidone) | 0 | |
| Double-blind Treatment | STARTED | Open-Label Treatment (Placebo) | 0 | |
| Double-blind Treatment | COMPLETED | Pirfenidone | 94 | |
| Double-blind Treatment | COMPLETED | Placebo | 110 | |
| Double-blind Treatment | COMPLETED | Open-Label Treatment (Pirfenidone) | 0 | |
| Double-blind Treatment | COMPLETED | Open-Label Treatment (Placebo) | 0 | |
| Double-blind Treatment | NOT COMPLETED | Pirfenidone | 33 | |
| Double-blind Treatment | NOT COMPLETED | Placebo | 16 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events388
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Pirfenidone | 7 | 127 | 7 |
| other | Constipation | Gastrointestinal disorders | Placebo | 4 | 124 | 4 |
| other | Constipation | Gastrointestinal disorders | Open-Label Treatment (Pirfenidone) | 6 | 94 | 6 |
| other | Constipation | Gastrointestinal disorders | Open-Label Treatment (Placebo) | 3 | 110 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Pirfenidone | 23 | 127 | 27 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 23 | 124 | 24 |
| other | Diarrhoea | Gastrointestinal disorders | Open-Label Treatment (Pirfenidone) | 9 | 94 | 16 |
| other | Diarrhoea | Gastrointestinal disorders | Open-Label Treatment (Placebo) | 15 | 110 | 15 |
| other | Dyspepsia | Gastrointestinal disorders | Pirfenidone | 17 | 127 | 21 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 7 | 124 | 7 |
1 to 10 of 388Source ClinicalTrials.gov
See all 388 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pirfenidone | 4 | 127 |
| Total, all-cause mortality | Placebo | 7 | 124 |
| Total, all-cause mortality | Open-Label Treatment (Pirfenidone) | 7 | 94 |
| Total, all-cause mortality | Open-Label Treatment (Placebo) | 9 | 110 |
| Total, other adverse events | Pirfenidone | 107 | 127 |
| Total, other adverse events | Placebo | 81 | 124 |
| Total, other adverse events | Open-Label Treatment (Pirfenidone) | 64 | 94 |
| Total, other adverse events | Open-Label Treatment (Placebo) | 86 | 110 |
| Total, serious adverse events | Pirfenidone | 18 | 127 |
| Total, serious adverse events | Placebo | 20 | 124 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pirfenidone vs Placebo: Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03099187
GET https://conductscience.org/api/trials/v1/NCT03099187/registered?page=2