Trial Outcomes & Findings for Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF (NCT NCT00650091)
NCT ID: NCT00650091
Last Updated: 2015-06-02
Results Overview
Change from Baseline in Forced Vital Capacity at 60 weeks (units in liters)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
264 participants
Primary outcome timeframe
Measured as the estimated change from baseline to Week 60
Results posted on
2015-06-02
Participant Flow
Initial Study Design: Subjects are randomly assigned to receive a three-drug regimen of prednisone, azathioprine, and acetylcysteine; acetylcysteine alone; or placebo. Amended Study Design: The three-drug regimen was removed from the protocol due to safety concerns on 10/14/2011. Subjects are randomly assigned to acetylcysteine or placebo.
Participants in the Pred/AZA/NAC group were discontinued and not re-randomized in the amended study.
Participant milestones
| Measure |
N-Acetylcysteine
Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day.
|
Placebo
Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day.
|
Pred/AZA/NAC
The prednisone dose was started at 0.5 mg per kilo- gram of ideal body weight and was tapered to 0.15 mg per kilogram during a period of 25 weeks.
The azathioprine dose (maximum, 150 mg per day) was based on the patient's ideal weight, concurrent use of allopurinol, and thiopurine methyl-transferase (TPMT) activity. NAC was prescribed at 600 mg orally three times a day.
|
|---|---|---|---|
|
Initial Study Design - Interim Analysis
STARTED
|
81
|
78
|
77
|
|
Initial Study Design - Interim Analysis
COMPLETED
|
81
|
78
|
77
|
|
Initial Study Design - Interim Analysis
NOT COMPLETED
|
0
|
0
|
0
|
|
Amended Study Design
STARTED
|
133
|
131
|
0
|
|
Amended Study Design
COMPLETED
|
110
|
111
|
0
|
|
Amended Study Design
NOT COMPLETED
|
23
|
20
|
0
|
Reasons for withdrawal
| Measure |
N-Acetylcysteine
Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day.
|
Placebo
Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day.
|
Pred/AZA/NAC
The prednisone dose was started at 0.5 mg per kilo- gram of ideal body weight and was tapered to 0.15 mg per kilogram during a period of 25 weeks.
The azathioprine dose (maximum, 150 mg per day) was based on the patient's ideal weight, concurrent use of allopurinol, and thiopurine methyl-transferase (TPMT) activity. NAC was prescribed at 600 mg orally three times a day.
|
|---|---|---|---|
|
Amended Study Design
Withdrawal by Subject
|
12
|
11
|
0
|
|
Amended Study Design
Physician Decision
|
5
|
0
|
0
|
|
Amended Study Design
Adverse Event
|
1
|
4
|
0
|
|
Amended Study Design
Lung transplantation
|
4
|
2
|
0
|
|
Amended Study Design
Other
|
1
|
3
|
0
|
Baseline Characteristics
Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF
Baseline characteristics by cohort
| Measure |
N-Acetylcysteine
n=133 Participants
Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day.
|
Placebo
n=131 Participants
Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day.
|
Total
n=264 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.3 years
STANDARD_DEVIATION 6.4 • n=39 Participants
|
67.2 years
STANDARD_DEVIATION 8.2 • n=41 Participants
|
67.8 years
STANDARD_DEVIATION 8.3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=39 Participants
|
33 Participants
n=41 Participants
|
59 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=39 Participants
|
98 Participants
n=41 Participants
|
205 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Measured as the estimated change from baseline to Week 60Population: Analysis population includes participants from the amended study design only.
Change from Baseline in Forced Vital Capacity at 60 weeks (units in liters)
Outcome measures
| Measure |
N-Acetylcysteine
n=133 Participants
Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day.
|
Placebo
n=131 Participants
Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day.
|
|---|---|---|
|
Overall Change in Forced Vital Capacity
|
-0.18 liters
Interval -0.23 to -0.12
|
-0.19 liters
Interval -0.24 to -0.14
|
SECONDARY outcome
Timeframe: Measured at Week 60Population: Analysis population includes participants from the amended study design only.
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.
Outcome measures
| Measure |
N-Acetylcysteine
n=133 Participants
Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day.
|
Placebo
n=131 Participants
Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day.
|
|---|---|---|
|
Disease Progression
|
27.1 percentage of participants
Interval 20.1 to 36.0
|
26.5 percentage of participants
Interval 19.5 to 35.4
|
SECONDARY outcome
Timeframe: Measured at Week 60Population: Analysis population includes participants from the amended study design only.
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.
Outcome measures
| Measure |
N-Acetylcysteine
n=133 Participants
Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day.
|
Placebo
n=131 Participants
Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day.
|
|---|---|---|
|
Acute Exacerbations
|
3 events
|
3 events
|
SECONDARY outcome
Timeframe: Measured at Week 60Population: Analysis population includes participants from the amended study design only.
Outcome measures
| Measure |
N-Acetylcysteine
n=133 Participants
Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day.
|
Placebo
n=131 Participants
Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day.
|
|---|---|---|
|
Respiratory Infections
|
6 events
|
6 events
|
SECONDARY outcome
Timeframe: Measured at Week 60Population: Analysis population includes participants from the amended study design only.
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.
Outcome measures
| Measure |
N-Acetylcysteine
n=133 Participants
Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day.
|
Placebo
n=131 Participants
Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day.
|
|---|---|---|
|
Number of Participants With Maintained Forced Vital Capacity Response
|
29 participants
|
35 participants
|
POST_HOC outcome
Timeframe: Baseline, 15, 30, 45, 60 weekPopulation: Analysis population includes participants from the amended study design only.
Change from Baseline in Forced Vital Capacity at 15, 30, 45, and 60 weeks (units in liters)
Outcome measures
| Measure |
N-Acetylcysteine
n=133 Participants
Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day.
|
Placebo
n=131 Participants
Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day.
|
|---|---|---|
|
Change in Forced Vital Capacity
15 week
|
-0.07 liters
Standard Deviation 0.19
|
-0.04 liters
Standard Deviation 0.19
|
|
Change in Forced Vital Capacity
30 week
|
-0.07 liters
Standard Deviation 0.20
|
-0.08 liters
Standard Deviation 0.25
|
|
Change in Forced Vital Capacity
45 week
|
-0.15 liters
Standard Deviation 0.25
|
-0.15 liters
Standard Deviation 0.30
|
|
Change in Forced Vital Capacity
60 week
|
-0.16 liters
Standard Deviation 0.26
|
-0.15 liters
Standard Deviation 0.30
|
Adverse Events
N-Acetylcysteine
Serious events: 25 serious events
Other events: 123 other events
Deaths: 0 deaths
Placebo
Serious events: 20 serious events
Other events: 117 other events
Deaths: 0 deaths
Initial Study: Pred/AZA/NAC
Serious events: 24 serious events
Other events: 68 other events
Deaths: 0 deaths
Initial Study: Placebo
Serious events: 8 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
N-Acetylcysteine
n=133 participants at risk
Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day.
|
Placebo
n=131 participants at risk
Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day.
|
Initial Study: Pred/AZA/NAC
n=77 participants at risk
Participants will receive prednisone, azathioprine, and N-acetylcysteine (NAC) for 60 weeks.
|
Initial Study: Placebo
n=78 participants at risk
Placebo: Participants will receive placebo each day.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
6.0%
8/133 • Number of events 10 • Adverse events are reported for amended study only.
|
3.1%
4/131 • Number of events 6 • Adverse events are reported for amended study only.
|
10.4%
8/77 • Number of events 9 • Adverse events are reported for amended study only.
|
2.6%
2/78 • Number of events 3 • Adverse events are reported for amended study only.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary oedema
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
1.5%
2/131 • Number of events 2 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.75%
1/133 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
1.3%
1/77 • Number of events 1 • Adverse events are reported for amended study only.
|
1.3%
1/78 • Number of events 1 • Adverse events are reported for amended study only.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.76%
1/131 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.76%
1/131 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
1.3%
1/78 • Number of events 1 • Adverse events are reported for amended study only.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.76%
1/131 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Infections and infestations
Pneumonia
|
3.0%
4/133 • Number of events 4 • Adverse events are reported for amended study only.
|
3.8%
5/131 • Number of events 5 • Adverse events are reported for amended study only.
|
5.2%
4/77 • Number of events 4 • Adverse events are reported for amended study only.
|
1.3%
1/78 • Number of events 1 • Adverse events are reported for amended study only.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.76%
1/131 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Infections and infestations
Bronchitis
|
0.75%
1/133 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.76%
1/131 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.76%
1/131 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Infections and infestations
Gastroenteritis viral
|
0.75%
1/133 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.76%
1/131 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.76%
1/131 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Cardiac disorders
Coronary artery disease
|
1.5%
2/133 • Number of events 2 • Adverse events are reported for amended study only.
|
1.5%
2/131 • Number of events 2 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Cardiac disorders
Angina pectoris
|
1.5%
2/133 • Number of events 2 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
2/133 • Number of events 2 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.75%
1/133 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Cardiac disorders
Cardiac arrest
|
0.75%
1/133 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.75%
1/133 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Cardiac disorders
Right ventricular failure
|
0.75%
1/133 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
2.3%
3/131 • Number of events 3 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.76%
1/131 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.76%
1/131 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
1.3%
1/78 • Number of events 1 • Adverse events are reported for amended study only.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.76%
1/131 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
1.3%
1/78 • Number of events 1 • Adverse events are reported for amended study only.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.76%
1/131 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
1.3%
1/78 • Number of events 1 • Adverse events are reported for amended study only.
|
|
Cardiac disorders
Non-cardiac chest pain
|
1.5%
2/133 • Number of events 2 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Cardiac disorders
Chest pain
|
0.75%
1/133 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.76%
1/131 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.75%
1/133 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Nervous system disorders
Presyncope
|
0.75%
1/133 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.76%
1/131 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.75%
1/133 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.75%
1/133 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.76%
1/131 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.76%
1/131 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
1.3%
1/78 • Number of events 1 • Adverse events are reported for amended study only.
|
|
Vascular disorders
Hypertension
|
0.75%
1/133 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
0.00%
0/77 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Squamous Cell Carcinoma
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
1.3%
1/77 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
1.3%
1/77 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Nervous system disorders
syncope
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
1.3%
1/77 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
1.3%
1/77 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Respiratory, thoracic and mediastinal disorders
Intersticial Lung Disease
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
1.3%
1/77 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
1.3%
1/77 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
1.3%
1/77 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
2.6%
2/77 • Number of events 2 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
1.3%
1/77 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
General disorders
Adverse Drug Reaction
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
1.3%
1/77 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
General disorders
Death
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
1.3%
1/77 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Reproductive system and breast disorders
prostatitis
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
1.3%
1/77 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
1.3%
1/77 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Investigations
Drug Fever
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
1.3%
1/77 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of Idiopathic Pulmonary Fibrosis
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
1.3%
1/77 • Number of events 1 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
|
Cardiac disorders
Acute Myocardial infarction
|
0.00%
0/133 • Adverse events are reported for amended study only.
|
0.00%
0/131 • Adverse events are reported for amended study only.
|
2.6%
2/77 • Number of events 2 • Adverse events are reported for amended study only.
|
0.00%
0/78 • Adverse events are reported for amended study only.
|
Other adverse events
| Measure |
N-Acetylcysteine
n=133 participants at risk
Participants will receive N-acetylcysteine (NAC) for 60 weeks.
N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day.
|
Placebo
n=131 participants at risk
Participants will receive placebo for 60 weeks.
Placebo: Participants will receive placebo each day.
|
Initial Study: Pred/AZA/NAC
n=77 participants at risk
Participants will receive prednisone, azathioprine, and N-acetylcysteine (NAC) for 60 weeks.
|
Initial Study: Placebo
n=78 participants at risk
Placebo: Participants will receive placebo each day.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.8%
37/133 • Number of events 44 • Adverse events are reported for amended study only.
|
24.4%
32/131 • Number of events 39 • Adverse events are reported for amended study only.
|
16.9%
13/77 • Number of events 15 • Adverse events are reported for amended study only.
|
23.1%
18/78 • Number of events 20 • Adverse events are reported for amended study only.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.5%
22/133 • Number of events 25 • Adverse events are reported for amended study only.
|
19.8%
26/131 • Number of events 29 • Adverse events are reported for amended study only.
|
14.3%
11/77 • Number of events 12 • Adverse events are reported for amended study only.
|
12.8%
10/78 • Number of events 11 • Adverse events are reported for amended study only.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Pulmonary Fibrosis
|
9.0%
12/133 • Number of events 14 • Adverse events are reported for amended study only.
|
6.1%
8/131 • Number of events 10 • Adverse events are reported for amended study only.
|
11.7%
9/77 • Number of events 12 • Adverse events are reported for amended study only.
|
5.1%
4/78 • Number of events 5 • Adverse events are reported for amended study only.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.5%
6/133 • Number of events 6 • Adverse events are reported for amended study only.
|
8.4%
11/131 • Number of events 12 • Adverse events are reported for amended study only.
|
1.3%
1/77 • Number of events 1 • Adverse events are reported for amended study only.
|
6.4%
5/78 • Number of events 5 • Adverse events are reported for amended study only.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.3%
27/133 • Number of events 31 • Adverse events are reported for amended study only.
|
19.8%
26/131 • Number of events 31 • Adverse events are reported for amended study only.
|
13.0%
10/77 • Number of events 11 • Adverse events are reported for amended study only.
|
12.8%
10/78 • Number of events 11 • Adverse events are reported for amended study only.
|
|
Infections and infestations
Bronchitis
|
11.3%
15/133 • Number of events 26 • Adverse events are reported for amended study only.
|
9.9%
13/131 • Number of events 15 • Adverse events are reported for amended study only.
|
7.8%
6/77 • Number of events 6 • Adverse events are reported for amended study only.
|
7.7%
6/78 • Number of events 8 • Adverse events are reported for amended study only.
|
|
Infections and infestations
Sinusitis
|
12.8%
17/133 • Number of events 22 • Adverse events are reported for amended study only.
|
7.6%
10/131 • Number of events 12 • Adverse events are reported for amended study only.
|
5.2%
4/77 • Number of events 6 • Adverse events are reported for amended study only.
|
6.4%
5/78 • Number of events 5 • Adverse events are reported for amended study only.
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
10/133 • Number of events 13 • Adverse events are reported for amended study only.
|
8.4%
11/131 • Number of events 15 • Adverse events are reported for amended study only.
|
5.2%
4/77 • Number of events 6 • Adverse events are reported for amended study only.
|
9.0%
7/78 • Number of events 10 • Adverse events are reported for amended study only.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.5%
18/133 • Number of events 19 • Adverse events are reported for amended study only.
|
11.5%
15/131 • Number of events 18 • Adverse events are reported for amended study only.
|
7.8%
6/77 • Number of events 7 • Adverse events are reported for amended study only.
|
9.0%
7/78 • Number of events 8 • Adverse events are reported for amended study only.
|
|
Gastrointestinal disorders
Nausea
|
10.5%
14/133 • Number of events 14 • Adverse events are reported for amended study only.
|
5.3%
7/131 • Number of events 9 • Adverse events are reported for amended study only.
|
13.0%
10/77 • Number of events 14 • Adverse events are reported for amended study only.
|
5.1%
4/78 • Number of events 4 • Adverse events are reported for amended study only.
|
|
Gastrointestinal disorders
Constipation
|
9.0%
12/133 • Number of events 13 • Adverse events are reported for amended study only.
|
3.1%
4/131 • Number of events 4 • Adverse events are reported for amended study only.
|
2.6%
2/77 • Number of events 2 • Adverse events are reported for amended study only.
|
5.1%
4/78 • Number of events 4 • Adverse events are reported for amended study only.
|
|
General disorders
Fatigue
|
6.8%
9/133 • Number of events 9 • Adverse events are reported for amended study only.
|
6.9%
9/131 • Number of events 9 • Adverse events are reported for amended study only.
|
10.4%
8/77 • Number of events 9 • Adverse events are reported for amended study only.
|
7.7%
6/78 • Number of events 6 • Adverse events are reported for amended study only.
|
|
General disorders
Oedema peripheral
|
6.8%
9/133 • Number of events 11 • Adverse events are reported for amended study only.
|
4.6%
6/131 • Number of events 6 • Adverse events are reported for amended study only.
|
2.6%
2/77 • Number of events 3 • Adverse events are reported for amended study only.
|
3.8%
3/78 • Number of events 3 • Adverse events are reported for amended study only.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
10/133 • Number of events 10 • Adverse events are reported for amended study only.
|
7.6%
10/131 • Number of events 13 • Adverse events are reported for amended study only.
|
2.6%
2/77 • Number of events 2 • Adverse events are reported for amended study only.
|
6.4%
5/78 • Number of events 8 • Adverse events are reported for amended study only.
|
|
Nervous system disorders
Headache
|
9.0%
12/133 • Number of events 14 • Adverse events are reported for amended study only.
|
9.2%
12/131 • Number of events 12 • Adverse events are reported for amended study only.
|
3.9%
3/77 • Number of events 3 • Adverse events are reported for amended study only.
|
3.8%
3/78 • Number of events 3 • Adverse events are reported for amended study only.
|
|
Nervous system disorders
Dizziness
|
6.0%
8/133 • Number of events 9 • Adverse events are reported for amended study only.
|
6.1%
8/131 • Number of events 10 • Adverse events are reported for amended study only.
|
6.5%
5/77 • Number of events 7 • Adverse events are reported for amended study only.
|
7.7%
6/78 • Number of events 8 • Adverse events are reported for amended study only.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place