Trial · NCT00650091

Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF

NCT00650091, Phase 3, Completed, Duke University; results first posted 2015-06-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF. Trials, record NCT00650091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00650091

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF
NCT number: NCT00650091
Status: Completed
Phases: Phase 3
Enrollment: 264 participants, actual
Lead sponsor: Duke University
Conditions: Pulmonary Fibrosis
Interventions: N-acetylcysteine (NAC), Placebo
First posted: 2008-04-01
Last updated: 2015-06-02
Results first posted: 2015-06-02

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Change in Forced Vital Capacity	Measured as the estimated change from baseline to Week 60	Change from Baseline in Forced Vital Capacity at 60 weeks (units in liters)
Secondary	Disease Progression	Measured at Week 60	The time-to-death or a 10% decline in FVC will be defined as the time-to-disease progression. The 10% decline in FVC from enrollment must be confirmed on 2 consecutive visits no less than 6 weeks apart. For subjects with 2 consecutive visits with a 10% decline in FVC, the time-to-disease progression will be defined as the time interval between enrollment and the initial visit with a 10% FVC decline.
Secondary	Acute Exacerbations	Measured at Week 60	The following 3 criteria will define acute exacerbations in subjects with acute worsening of their respiratory conditions: 1\. Clinical (all of the following required): A) Unexplained worsening of dyspnea or cough within 30 days, triggering unscheduled medical care (e.g., emergency room, clinic, study visit, hospitalization). B) No clinical suspicion or overt evidence of cardiac event, pulmonary embolism, or deep venous thrombosis to explain acute worsening of dyspnea. C) No pneumothorax.
Secondary	Respiratory Infections	Measured at Week 60
Secondary	Number of Participants With Maintained Forced Vital Capacity Response	Measured at Week 60	Maintained forced vital capacity response was a binary variable taking on a value of 1 for participants with higher FVC % predicted at week 60 compared to baseline.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Change in Forced Vital Capacity	Measured as the estimated change from baseline to Week 60	Analysis population includes participants from the amended study design only.	liters	MEAN
SECONDARY	Disease Progression	Measured at Week 60	Analysis population includes participants from the amended study design only.	percentage of participants	NUMBER
SECONDARY	Acute Exacerbations	Measured at Week 60	Analysis population includes participants from the amended study design only.	events	NUMBER
SECONDARY	Respiratory Infections	Measured at Week 60	Analysis population includes participants from the amended study design only.	events	NUMBER
SECONDARY	Number of Participants With Maintained Forced Vital Capacity Response	Measured at Week 60	Analysis population includes participants from the amended study design only.	participants	NUMBER
POST_HOC	Change in Forced Vital Capacity	Baseline, 15, 30, 45, 60 week	Analysis population includes participants from the amended study design only.	liters	MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Change in Forced Vital Capacity	N-Acetylcysteine	-0.18	95% Confidence Interval -0.23 to -0.12	liters
Overall Change in Forced Vital Capacity	Placebo	-0.19	95% Confidence Interval -0.24 to -0.14	liters
Disease Progression	N-Acetylcysteine	27.1	95% Confidence Interval 20.1 to 36.0	percentage of participants
Disease Progression	Placebo	26.5	95% Confidence Interval 19.5 to 35.4	percentage of participants
Acute Exacerbations	N-Acetylcysteine	3		events
Acute Exacerbations	Placebo	3		events
Respiratory Infections	N-Acetylcysteine	6		events
Respiratory Infections	Placebo	6		events
Number of Participants With Maintained Forced Vital Capacity Response	N-Acetylcysteine	29		participants
Number of Participants With Maintained Forced Vital Capacity Response	Placebo	35		participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Initial Study Design - Interim Analysis	STARTED	N-Acetylcysteine	81
Initial Study Design - Interim Analysis	STARTED	Placebo	78
Initial Study Design - Interim Analysis	STARTED	Pred/AZA/NAC	77
Initial Study Design - Interim Analysis	COMPLETED	N-Acetylcysteine	81
Initial Study Design - Interim Analysis	COMPLETED	Placebo	78
Initial Study Design - Interim Analysis	COMPLETED	Pred/AZA/NAC	77
Initial Study Design - Interim Analysis	NOT COMPLETED	N-Acetylcysteine	0
Initial Study Design - Interim Analysis	NOT COMPLETED	Placebo	0
Initial Study Design - Interim Analysis	NOT COMPLETED	Pred/AZA/NAC	0
Amended Study Design	STARTED	N-Acetylcysteine	133

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events276

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	Cough	Respiratory, thoracic and mediastinal disorders	N-Acetylcysteine	37	133	44
other	Cough	Respiratory, thoracic and mediastinal disorders	Placebo	32	131	39
other	Cough	Respiratory, thoracic and mediastinal disorders	Initial Study: Pred/AZA/NAC	13	77	15
other	Cough	Respiratory, thoracic and mediastinal disorders	Initial Study: Placebo	18	78	20
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	N-Acetylcysteine	22	133	25
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Placebo	26	131	29
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Initial Study: Pred/AZA/NAC	11	77	12
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Initial Study: Placebo	10	78	11
other	Idiopathic Pulmonary Fibrosis	Respiratory, thoracic and mediastinal disorders	N-Acetylcysteine	12	133	14
other	Idiopathic Pulmonary Fibrosis	Respiratory, thoracic and mediastinal disorders	Placebo	8	131	10

1 to 10 of 276Source ClinicalTrials.gov

See all 276 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	N-Acetylcysteine
Total, all-cause mortality	Placebo
Total, all-cause mortality	Initial Study: Pred/AZA/NAC
Total, all-cause mortality	Initial Study: Placebo
Total, other adverse events	N-Acetylcysteine	123	133
Total, other adverse events	Placebo	117	131
Total, other adverse events	Initial Study: Pred/AZA/NAC	68	77
Total, other adverse events	Initial Study: Placebo	61	78
Total, serious adverse events	N-Acetylcysteine	25	133
Total, serious adverse events	Placebo	20	131

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22607134	DERIVED	PubMed
24836309	DERIVED	PubMed
25890798	DERIVED	PubMed
26111071	DERIVED	PubMed
35688625	DERIVED	PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10HL080413	Idiopathic Pulmonary Fibrosis Clinical Research Network	ANSTROM, KEVIN J	DUKE UNIVERSITY	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2005 to 2013

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
N-Acetylcysteine vs Placebo: Number of Participants With Maintained Forced Vital Capacity Response

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00650091

GET https://conductscience.org/api/trials/v1/NCT00650091/events?page=2

API reference For AI assistants