prednisone and Cryptogenic Fibrosing Alveolitis

prednisone has been researched along with Cryptogenic Fibrosing Alveolitis in 22 studies

Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.
prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid.

Research

Studies (22)

Authors

Clinical Trials (7)

Trial Overview

Trial Outcomes

Acute Exacerbations

"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." (NCT00650091)
Timeframe: Measured at Week 60

Disease Progression

"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." (NCT00650091)
Timeframe: Measured at Week 60

Number of Participants With Maintained Forced Vital Capacity Response

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. (NCT00650091)
Timeframe: Measured at Week 60

Overall Change in Forced Vital Capacity

Change from Baseline in Forced Vital Capacity at 60 weeks (units in liters) (NCT00650091)
Timeframe: Measured as the estimated change from baseline to Week 60

Respiratory Infections

(NCT00650091)
Timeframe: Measured at Week 60

Change in Forced Vital Capacity

Change from Baseline in Forced Vital Capacity at 15, 30, 45, and 60 weeks (units in liters) (NCT00650091)
Timeframe: Baseline, 15, 30, 45, 60 week

Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)

This is a binary score (1 or 0) with 1 being better than 0. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo. (NCT00517933)
Timeframe: Measured at Week 12

Change in Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Adjusted Values)

The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo. (NCT00517933)
Timeframe: Baseline, 12 week

Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted Values

Change in DLCO (% predicted) measured at baseline (time 0), and week 12 comparing the sildenafil and placebo groups. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo. (NCT00517933)
Timeframe: Baseline, Week 12

Change in Dyspnea

"The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = not at all to 5 = maximal or unable to do because of breathlessness) to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better." (NCT00517933)
Timeframe: Measured from enrollment to 12 weeks (phase I)

Change in EuroQOL (EQ-5D) Utility - Adjusted Value

"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo." (NCT00517933)
Timeframe: Baseline, 12 weeks

Change in EuroQOL Thermometer (Adjusted Value)

"The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state.~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo." (NCT00517933)
Timeframe: Baseline, 12 weeks

Change in Forced Vital Capacity (FVC) Adjusted Values

Change in FVC (liters) from baseline (time 0) to week 12 comparing the sildenafil and placebo groups. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo. (NCT00517933)
Timeframe: Baseline, Week 12

Change in ICECAP-O Adjusted Value

"The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best).~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo." (NCT00517933)
Timeframe: Baseline, 12 weeks

Change in SF36 Aggregate Physical (Adjusted Value)

"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.~Each score ranges from 0 to 100, with a higher score indicating better function.~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo." (NCT00517933)
Timeframe: Baseline, 12 weeks

Change in Short Form Health Survey (SF36) General Health - Adjusted Value

"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.~Each score ranges from 0 to 100, with a higher score indicating better function.~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo." (NCT00517933)
Timeframe: Baseline, 12 weeks

Change in St. George's Respiratory Questionnaire (Activity Score) Adjusted Value

The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo. (NCT00517933)
Timeframe: Baseline, 12 weeks

Change in St. George's Respiratory Questionnaire (Impacts Score) Adjusted Value

The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo. (NCT00517933)
Timeframe: Baseline, 12 weeks

Change in St. George's Respiratory Questionnaire (Symptoms Score) Adjusted Value

The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo. (NCT00517933)
Timeframe: Baseline, 12 weeks

Change in St. George's Respiratory Questionnaire (Total Score) (Adjusted Values)

The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.) Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo. (NCT00517933)
Timeframe: Baseline, 12 week

Desaturation During 6-minute Walk Test (6MWT)

The 6MWT was stopped when the pulse oximetry (SpO2) dropped to below 80% for six consecutive seconds. The estimates are based on the Kaplan-Meier event curves with minutes walked as the x-axis. (NCT00517933)
Timeframe: Week 12

Estimated Change From Baseline to 12 Weeks in 6-minute Walk Distance

The 6MWT measures the distance that a participant can walk in a period of 6 minutes. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo. (NCT00517933)
Timeframe: Baseline, week 12

6-minute Walk Distance (6MWT)

The 6MWT measures the distance that a participant can walk in a period of 6 minutes. (NCT00517933)
Timeframe: Baseline, 6 week, 12 week

Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Raw Scores)

The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. (NCT00517933)
Timeframe: Baseline, 6 week, 12 week

Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)

Raw scores of DLCO (% predicted) measured at baseline (time 0), week 6, and week 12 comparing the sildenafil and placebo groups (NCT00517933)
Timeframe: Baseline, Week 6, Week 12

EuroQOL (EQ-5D) Utility

"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.~Mean raw scores of EuroQOL Utility." (NCT00517933)
Timeframe: Baseline, 6 weeks, 12 weeks

EuroQOL Thermometer

"The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state.~Mean raw scores of EuroQOL Thermometer." (NCT00517933)
Timeframe: Baseline, 6 weeks, 12 weeks

Forced Vital Capacity (FVC)

Raw scores of FVC (liters) from baseline (time 0) to week 6 and 12 comparing the sildenafil and placebo groups (NCT00517933)
Timeframe: Baseline, Week 6, Week 12

ICECAP-O

The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best). Mean raw scores of ICECAP-O. (NCT00517933)
Timeframe: Baseline, 6 weeks, 12 weeks

Short Form Health Survey (SF36) Aggregate Physical

"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.~Each score ranges from 0 to 100, with a higher score indicating better function.~Mean raw scores of SF36 Aggregate Physical." (NCT00517933)
Timeframe: Baseline, 6 weeks, 12 weeks

Short Form Health Survey (SF36) General Health

"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.~Each score ranges from 0 to 100, with a higher score indicating better function.~Mean raw scores of SF36 General Health" (NCT00517933)
Timeframe: Baseline, 6 weeks, 12 weeks

St. George's Respiratory Questionnaire (Activity Score)

The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire. (NCT00517933)
Timeframe: Baseline, 6 weeks, 12 weeks

St. George's Respiratory Questionnaire (Impacts Score)

The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire. (NCT00517933)
Timeframe: Baseline, 6 weeks, 12 weeks

St. George's Respiratory Questionnaire (Symptoms Score)

The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire. Mean raw scores of the St. George's Respiratory Questionnaire. (NCT00517933)
Timeframe: Baseline, 6 weeks, 12 weeks

St. George's Respiratory Questionnaire (Total Score)

Mean raw scores of the St. George's Respiratory Questionnaire. The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.) (NCT00517933)
Timeframe: Baseline, 6 weeks, 12 weeks

University of California at San Diego (UCSD) Shortness of Breath Questionnaire Total

"The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = not at all to 5 = maximal or unable to do because of breathlessness) to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better. (Raw scores)~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo." (NCT00517933)
Timeframe: Baseline, 6 weeks, 12 weeks

Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)

(NCT00957242)
Timeframe: maximum of 48 weeks

All Cause Mortality

(NCT00957242)
Timeframe: maximum of 48 weeks

All-cause Hospitalizations

(NCT00957242)
Timeframe: maximum 48 weeks

Bleeding Events

(NCT00957242)
Timeframe: maximum of 48 weeks

Cardiovascular Mortality or Morbidity

Measured at 48 Weeks (NCT00957242)
Timeframe: maximum of 48 weeks

Change in 6-minute Walk Distance (6MWD)

The 6MWD is a measure of exercise tolerance. Change in exercise tolerance is calculated at the latest time point (up to 48 weeks) minus the earliest time point (at baseline). (NCT00957242)
Timeframe: Change from baseline to last visit (maximum of 48 weeks)

Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) From Baseline to 16 Weeks

The DLCO measures the partial pressure difference between inspired and expired carbon monoxide. (NCT00957242)
Timeframe: Week 48 / Final Visit

Change in Forced Vital Capacity (FVC) From Baseline to 16 Weeks

Week-16 change from Baseline (NCT00957242)
Timeframe: 16 weeks

Death, Non-bleeding/Non-elective Hospitalization, or >10% Drop in Forced Vital Capacity

Death, non-bleeding/non-elective hospitalization, or >10% drop in forced vital capacity. (NCT00957242)
Timeframe: Events up to 48 weeks

Fibrin D-dimer Change From Baseline to 16 Weeks

Biomarker that measures biologic activities in patients as opposed to response. (NCT00957242)
Timeframe: maximum of 48 weeks

Respiratory-related Hospitalizations

(NCT00957242)
Timeframe: maximum 48 weeks

Total Score St. George's Respiratory Questionnaire (SGRQ)

The SGRQ is a quality of life measurement used to assess respiratory well being with a 0*-100 range (*indicates better health--lower is better). (NCT00957242)
Timeframe: Week 16 Change from Baseline

Reviews

3 reviews available for prednisone and Cryptogenic Fibrosing Alveolitis

Trials

6 trials available for prednisone and Cryptogenic Fibrosing Alveolitis

Other Studies

13 other studies available for prednisone and Cryptogenic Fibrosing Alveolitis