carbon monoxide and Cryptogenic Fibrosing Alveolitis

carbon monoxide has been researched along with Cryptogenic Fibrosing Alveolitis in 60 studies

Carbon Monoxide: Carbon monoxide (CO). A poisonous colorless, odorless, tasteless gas. It combines with hemoglobin to form carboxyhemoglobin, which has no oxygen carrying capacity. The resultant oxygen deprivation causes headache, dizziness, decreased pulse and respiratory rates, unconsciousness, and death. (From Merck Index, 11th ed)
carbon monoxide : A one-carbon compound in which the carbon is joined only to a single oxygen. It is a colourless, odourless, tasteless, toxic gas.

Research

Studies (60)

Authors

Clinical Trials (22)

Trial Overview

Trial Outcomes

Absolute Change in Percent Predicted Forced Vital Capacity(FVC)

Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72. It is calculated as the simple difference between baseline Percent Predicted FVC measurements and week 72 Percent Predicted FVC measurements. (NCT00287729)
Timeframe: Baseline to week 72

Change in Dyspnea Score

The mean change from baseline to week 72 in Dyspnea score was measured by the University of San Diego Shortness of Breath Questionnaire (UCSD SOBQ). The SOBQ is used to assess shortness of breath with various activities of daily living (for example, brushing ones teeth or mowing the lawn). Patients rated the severity of their shortness of breath experienced on an average day during the past week on a 6 point scale (0 to 5),with 0= not at all breathless, 4= severely breathless and 5= Maximally or unable to do because of breathlessness. (NCT00287729)
Timeframe: Baseline to Week 72

Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs

The change from baseline to week 72 in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs. It is calculated as the simple difference between baseline DLco measurements and week 72 DLco measurements. (NCT00287729)
Timeframe: Baseline to Week 72

Change in the Six-Minute Walk Test (6MWT) Distance

The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test. This measure was calculated as the simple difference between baseline distanced walked over 6 minutes and week 72 distance walked over 6 minutes as measured in meters (m). (NCT00287729)
Timeframe: Baseline to Week 72

Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test

The change from baseline to week 72 in worst oxygen saturation during the 6-Minute Walk Test as measure by Pulse Oximetry (SpO2) Level. It is calculated as the simple difference between baseline SpO2 measurements and week 72 SpO2 measurements. (NCT00287729)
Timeframe: Baseline to Week 72

Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity

Based on the change in baseline percent predicted FVC at week 72, patients were assigned to 1 of 5 categories: mild decline (<10% but >=0% decline), moderate decline (<20% but >=10% decline), severe decline (>=20% decline), mild improvement (>0% but <10% improvement), or moderate improvement (>=10% improvement). Those who died or had a lung transplant before Week 72 were included in the severe decline category. The results indicate the number of patients who experience Categorical Change in Percent Predicted Forced Vital Capacity. (NCT00287729)
Timeframe: Baseline to week 72

Progression-free Survival

Progression is defined as the first occurrence of a 10% absolute decline from baseline in percent predicted Forced Vital Capacity, a 15% absolute decline from baseline in percent predicted hemoglobin(Hgb)-corrected carbon monoxide diffusing capacity (DLco), or, death. (NCT00287729)
Timeframe: Baseline to Week 72

Worsening of IPF

"Worsening of IPF was defined by the occurrence of any of the following events:~Acute IPF exacerbation, IPF-related death, Lung transplantation, or Respiratory hospitalization." (NCT00287729)
Timeframe: Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.

Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks

Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). (NCT01335477)
Timeframe: Baseline and 52 weeks

Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks

Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). (NCT01335477)
Timeframe: Baseline and 52 weeks

Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks.

"Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.~For this endpoint reported means represent the adjusted rate." (NCT01335477)
Timeframe: 52 weeks

Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks

Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). (NCT01335477)
Timeframe: baseline and 52 weeks

Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)

"The cough domains of the Cough and Sputum Assessment Questionnaire (CASA- Q) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)." (NCT01335477)
Timeframe: baseline and 52 weeks

Change From Baseline in Cough Symptom Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)

"The cough domains of the Cough and Sputum Assessment Questionnaire (CASAQ(CD)) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)." (NCT01335477)
Timeframe: baseline and 52 weeks

Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)

"SGRQ-I is the IPF specific version of SGRQ comprises of selected items from the SGRQ divided into three components, Symptoms, Activity and Impact. Each component is scored separately. The weights for all items with a positive responses are summed and the weights from missed items are deducted from the maximum possible weight for the total score.~The total score is calculated by dividing the summed weights from positive items in the questionnaire by maximum possible weight for all items in the questionnaire. The total score can range from 0 to 100 with a lower score denoting a better health-related quality of life. Change from baseline is calculated as the difference between total score at week 52 and total score at baseline as measured by the scale." (NCT01335477)
Timeframe: baseline and 52 weeks

Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks

"This is a key secondary endpoint. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.~The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.~Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)." (NCT01335477)
Timeframe: Baseline and 52 weeks

Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)

"SGRQ Activity score is a sub-component of SGRQ total score and concerned with activities that cause or are limited by breathlessness. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better activity-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)." (NCT01335477)
Timeframe: baseline and 52 weeks

Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)

"SGRQ Impact score is a sub-component of SGRQ total score and covers a range of aspects concerned with social functioning and psychological disturbances resulting from airway disease. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better impact-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)." (NCT01335477)
Timeframe: baseline and 52 weeks

Change From Baseline in SGRQ Symptom Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)

"SGRQ Symptom score is a sub-component of SGRQ total score and is concerned with the effect of respiratory symptoms, their frequency and severity. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better symptom-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)." (NCT01335477)
Timeframe: baseline and 52 weeks

Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)

"Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)." (NCT01335477)
Timeframe: baseline and 52 weeks

Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks

Means presented are the adjusted means. Adjusted mean is based on all analyzed patients in the model (not only patients with a change from baseline to week 52) (NCT01335477)
Timeframe: baseline and 52 weeks

FVC Responders Using 10% Threshold at 52 Weeks

FVC responders using 10% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 10% and with an FVC evaluation at 52 weeks. (NCT01335477)
Timeframe: 52 weeks

Proportion of FVC Responders Using 5% Threshold at 52 Weeks

Proportion of FVC responders using 5% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 5% and with an FVC evaluation at 52 weeks. (NCT01335477)
Timeframe: 52 weeks

Proportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)

Patient's Global Impression of Change (PGI-C) responders are defined as 'Very much better'/ 'Much better'/ 'A little better'/ 'No change'. (NCT01335477)
Timeframe: 52 weeks

Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)

"Proportion of SGRQ responders at 52 weeks.~Responders defined as <= -4 points change in change from baseline in SGRQ total score at 52 weeks." (NCT01335477)
Timeframe: baseline and 52 weeks

Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks

Percentage change from baseline in FVC (% predicted) at 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). (NCT01335477)
Timeframe: Baseline and 52 weeks

Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks

Percentage change from baseline in FVC over 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). (NCT01335477)
Timeframe: Baseline and 52 weeks

Risk of an Acute IPF Exacerbation Over 52 Weeks

The incidence rate of exacerbations (calculated as the number of patients with at least 1 acute IPF exacerbation divided by the total number of years at risk in years*100) (NCT01335477)
Timeframe: 52 weeks

Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold

Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 10% threshold (decrease by 10%, increase by >10%, and change within ≤10%) (NCT01335477)
Timeframe: Baseline and 52 weeks

Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold

Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 5% threshold (decrease by >5%, increase by >5%, and change within ≤5%). (NCT01335477)
Timeframe: Baseline and 52 weeks

Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)

The EuroQol 5-dimensional Health State is based on a visual analog scale (EQ-VAS) representing the general patient's health state labelled from 100 (best imaginable health state) to 0 (worst imaginable health state). A higher score indicating a better health state. Change from baseline is calculated as the difference between health state at week 12, 24 and 52 respectively and health state at baseline as measured by the scale. (NCT01335477)
Timeframe: baseline, 12 weeks, 24 weeks and 52 weeks

Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)

"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death due to respiratory causes before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the the proportion of patients who died due to respiratory causes over 52 weeks (373 days time-period)." (NCT01335477)
Timeframe: 52 weeks

Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.

"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death or lung transplant or qualifying for lung transplant over 52 weeks are reported. A patient was considered qualifying for lung transplant by the investigator if he or she fulfilled the following criteria:~FVC <45% predicted or Carbon monoxide diffusion capacity (DL(CO)) <30% pred or Oxygen saturation on pulse oximetry (SpO2) <88% at rest, at sea level (to be adapted for other heights).~These criteria were evaluated by investigators judgement. Failure is the proportion of patients who died or had lung transplant or qualified for lung transplant over 52 weeks (373 days time-period)." (NCT01335477)
Timeframe: 52 weeks

Time to Death or Lung Transplant Over 52 Weeks

Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experience event (death or lung transplant) before or at 372 days after randomisation or last contact date (whichever occurs first) are reported. Failure is the proportion of patients who died or had lung transplant over 52 weeks (373 days time-period). (NCT01335477)
Timeframe: 52 weeks

Time to Death Over 52 Weeks

"Due to rare events, the median of time to event is not calculable, thus the percentages of patients who did or did not experienced death before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the proportion of patients who died over 52 weeks (373 days time-period)." (NCT01335477)
Timeframe: 52 weeks

Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation

"Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint. An acute exacerbation (reported as an AE by the investigator) was defined as follows:~Otherwise unexplained clinical features including all of the following:~Unexplained worsening or development of dyspnoea within 30 days New diffuse pulmonary infiltrates on chest X-ray, and/or new HRCT parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit Exclusion of infection as per routine clinical practice and microbiological studies Exclusion of alternative causes as per routine clinical practice including left heart failure, pulmonary embolism and identifiable cause of acute lung injury.~Failure is the proportion of patients with at least one acute IPF exacerbation over 52 weeks, based on all investigator-reported AEs ." (NCT01335477)
Timeframe: 52 weeks

Time to On-treatment Death

"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not die before or at last trial medication intake + 28 days were censored at last trial medication intake + 28 days and reported.~Failure is the the proportion of patients who died on-treatment." (NCT01335477)
Timeframe: 52 weeks

Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52

(NCT01366209)
Timeframe: 52 weeks

Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks

Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). (NCT01335464)
Timeframe: Baseline and 52 weeks

Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks

Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). (NCT01335464)
Timeframe: Baseline and 52 weeks

Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks

"Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.~For this endpoint reported means represent the adjusted rate" (NCT01335464)
Timeframe: 52 weeks

Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks

Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). (NCT01335464)
Timeframe: Baseline and 52 weeks

Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks : Patient Reported Outcomes (PROs)

"The cough domains of the Cough and Sputum Assessment Questionnaire (CASA-Q) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)." (NCT01335464)
Timeframe: Baseline and 52 weeks

Change From Baseline in Cough Symptoms Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)

"The cough domains of the Cough and Sputum Assessment Questionnaire (CASAQ(CD)) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)." (NCT01335464)
Timeframe: Baseline and 52 weeks

Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)

"SGRQ-I is the IPF specific version of SGRQ comprises of selected items from the SGRQ divided into three components, Symptoms, Activity and Impact. Each component is scored separately. The weights for all items with a positive responses are summed and the weights from missed items are deducted from the maximum possible weight for the total score.~The total score is calculated by dividing the summed weights from positive items in the questionnaire by maximum possible weight for all items in the questionnaire. The total score can range from 0 to 100 with a lower score denoting a better health-related quality of life. Change from baseline is calculated as the difference between total score at week 52 and total score at baseline as measured by the scale." (NCT01335464)
Timeframe: Baseline and 52 weeks

Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks

"This is a key secondary endpoint.~SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.~The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.~Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)." (NCT01335464)
Timeframe: baseline and 52 weeks

Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)

"SGRQ Activity score is a sub-component of SGRQ total score and concerned with activities that cause or are limited by breathlessness. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better activity-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)." (NCT01335464)
Timeframe: baseline and 52 weeks

Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)

"SGRQ Impact score is a sub-component of SGRQ total score and covers a range of aspects concerned with social functioning and psychological disturbances resulting from airway disease. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better impact-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)." (NCT01335464)
Timeframe: Baseline and 52 weeks

Change From Baseline in SGRQ Symptom Score at 52 Weeks: Patient Reported Outcomes (PROs)

"SGRQ Symptom score is a sub-component of SGRQ total score and is concerned with the effect of respiratory symptoms, their frequency and severity. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better symptom-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)." (NCT01335464)
Timeframe: Baseline and 52 weeks

Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)

"Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)." (NCT01335464)
Timeframe: baseline and 52 weeks

Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks

Means presented are the adjusted means. Adjusted mean is based on all analyzed patients in the model (not only patients with a change from baseline to week 52) (NCT01335464)
Timeframe: Baseline and 52 weeks

FVC Responders Using 10% Threshold at 52 Weeks

FVC responders using 10% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 10% and with an FVC evaluation at 52 weeks. (NCT01335464)
Timeframe: 52 weeks

Proportion of FVC Responders Using 5% Threshold at 52 Weeks

Proportion of FVC responders using 5% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 5% and with an FVC evaluation at 52 weeks. (NCT01335464)
Timeframe: 52 weeks

Proportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)

Patient's Global Impression of Change (PGI-C) responders are defined as 'Very much better'/ 'Much better'/ 'A little better'/ 'No change'. (NCT01335464)
Timeframe: 52 weeks

Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)

"Proportion of SGRQ responders at 52 weeks~Responders defined as <= -4 points change in change from baseline in SGRQ total score at 52 weeks." (NCT01335464)
Timeframe: Baseline and 52 weeks

Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks

Percentage change from baseline in FVC (% predicted) at 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). (NCT01335464)
Timeframe: Baseline and 52 weeks

Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks

Percentage change from baseline in FVC over 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). (NCT01335464)
Timeframe: Baseline and 52 weeks

Risk of an Acute IPF Exacerbation Over 52 Weeks

The incidence rate of exacerbations (calculated as the number of patients with at least 1 acute IPF exacerbation divided by the total number of years at risk in years*100) (NCT01335464)
Timeframe: 52 weeks

Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold

Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 10% threshold (decrease by 10%, increase by >10%, and change within ≤10%) (NCT01335464)
Timeframe: Baseline and 52 weeks

Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold

Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 5% threshold (decrease by >5%, increase by >5%, and change within ≤5%). (NCT01335464)
Timeframe: Baseline and 52 weeks

Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)

The EuroQol 5-dimensional Health State is based on a visual analog scale (EQ-VAS) representing the general patient's health state labelled from 100 (best imaginable health state) to 0 (worst imaginable health state). A higher score indicating a better health state. Change from baseline is calculated as the difference between health state at week 12, 24 and 52 respectively and health state at baseline as measured by the scale. (NCT01335464)
Timeframe: baseline, 12 weeks, 24 weeks and 52 weeks

Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)

"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death due to respiratory causes before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the the proportion of patients who died due to respiratory causes over 52 weeks (373 days time-period)." (NCT01335464)
Timeframe: 52 weeks

Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.

"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death or lung transplant or qualifying for lung transplant over 52 weeks are reported. A patient was considered qualifying for lung transplant by the investigator if he or she fulfilled the following criteria:~FVC <45% predicted or Carbon monoxide diffusion capacity (DL(CO)) <30% pred or Oxygen saturation on pulse oximetry (SpO2) <88% at rest, at sea level (to be adapted for other heights).~These criteria were evaluated by investigators judgement. Failure is the proportion of patients who died or had lung transplant or qualified for lung transplant over 52 weeks (373 days time-period)." (NCT01335464)
Timeframe: 52 weeks

Time to Death or Lung Transplant Over 52 Weeks

"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experience event (death or lung transplant) before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the proportion of patients who died or had lung transplant over 52 weeks (373 days time-period)." (NCT01335464)
Timeframe: 52 weeks

Time to Death Over 52 Weeks

"Due to rare events, the median of time to event is not calculable, thus the percentages of patients who did or did not experienced death before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the proportion of patients who died over 52 weeks (373 days time-period) ." (NCT01335464)
Timeframe: 52 weeks

Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation

"Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint. An acute exacerbation (reported as an AE by the investigator) was defined as follows:~Otherwise unexplained clinical features including all of the following:~Unexplained worsening or development of dyspnoea within 30 days~New diffuse pulmonary infiltrates on chest X-ray, and/or new HRCT parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit~Exclusion of infection as per routine clinical practice and microbiological studies~Exclusion of alternative causes as per routine clinical practice including left heart failure, pulmonary embolism and identifiable cause of acute lung injury.~Failure is the proportion of patients with at least one acute IPF exacerbation over 52 weeks, based on all investigator-reported AEs ." (NCT01335464)
Timeframe: 52 weeks

Time to On-treatment Death

"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not die before or at last trial medication intake + 28 days were censored at last trial medication intake + 28 days and reported.~Failure is the the proportion of patients who died on-treatment." (NCT01335464)
Timeframe: 52 weeks

Absolute Change From Baseline in Distance Walk (6-MWT)

Absolute change from baseline in distance walk (6-MWT) at 52 weeks. The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region. (NCT00514683)
Timeframe: Baseline and 52 weeks

Absolute Change From Baseline in DLCO

"Absolute change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region." (NCT00514683)
Timeframe: Baseline and 52 weeks

Absolute Change From Baseline in Dyspnoea Rating on Borg Scale Before Exercise (6-MWT)

"Absolute change from baseline in Dyspnoea rating before exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below :~0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal).~The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region." (NCT00514683)
Timeframe: Baseline and 52 weeks

Absolute Change From Baseline in FEV1/FVC

"Change from baseline of percentage of FVC expelled in the first second of a forced expiration (FEV1/FVC) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region." (NCT00514683)
Timeframe: Baseline and 52 weeks

Absolute Change From Baseline in FVC

"Change from baseline in percentage of absolute Forced Vital Capacity (FVC) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region." (NCT00514683)
Timeframe: Baseline and 52 weeks

Absolute Change From Baseline in FVC%Pred

"Change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region." (NCT00514683)
Timeframe: Baseline and 52 weeks

Absolute Change From Baseline in P(A-a)O2

Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a)O2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region. (NCT00514683)
Timeframe: Baseline and 52 weeks

Absolute Change From Baseline in PaCO2

Absolute change from baseline in Arterial carbon dioxyde partial pressure (PaCO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region. (NCT00514683)
Timeframe: Baseline and 52 weeks

Absolute Change From Baseline in PaO2

Absolute change from baseline in Arterial oxygen partial pressure (PaO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region. (NCT00514683)
Timeframe: Baseline and 52 weeks

Absolute Change From Baseline in SpO2 at Rest

"Absolute change from baseline in oxygen saturation (SpO2) at rest.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region." (NCT00514683)
Timeframe: Baseline and 52 weeks

Change From Baseline in Dyspnoea Rating on Borg Scale After Exercise (6-MWT)

"Change from baseline in Dyspnoea rating after exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below :~0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal).~The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region." (NCT00514683)
Timeframe: Baseline and 52 weeks

Change From Baseline in IC

Change from Baseline in Inspiratory Capacity (IC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region. (NCT00514683)
Timeframe: Baseline and 52 weeks

Change From Baseline in RV

Change from Baseline in Residual volume (RV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region. (NCT00514683)
Timeframe: Baseline and 52 weeks

Change From Baseline in SGRQ Domain Score Impacts

"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region." (NCT00514683)
Timeframe: Baseline and 52 weeks

Change From Baseline in SGRQ Domain Score Symptoms

"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score symptoms. Scores range from 0 to 100, with higher scores indicating more limitations.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region." (NCT00514683)
Timeframe: Baseline and 52 weeks

Change From Baseline in SGRQ Total Score

"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) total score. Total score is defined as sum of the three domain scores symptoms, activities and impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region." (NCT00514683)
Timeframe: Baseline and 52 weeks

Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Domain Score Activities

"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score activities. Scores range from 0 to 100, with higher scores indicating worst possible health status.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region." (NCT00514683)
Timeframe: Baseline and 52 weeks

Change From Baseline in TGV

Change from Baseline in Thoracic gas volume (TGV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region. (NCT00514683)
Timeframe: Baseline and 52 weeks

Change From Baseline in TLC

Change from Baseline in Total Lung Capacity (TLC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region. (NCT00514683)
Timeframe: Baseline and 52 weeks

Change From Baseline in VC

Change from baseline in Vital capacity (VC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region. (NCT00514683)
Timeframe: Baseline and 52 weeks

Number of Patients With at Least One IPF Exacerbation

Number of patients with at least one Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks (NCT00514683)
Timeframe: 52 weeks

Occurrences of IPF Exacerbations Per Patient Per Year

Occurrences of Idiopathic Pulmonary Fibrosis (IPF) exacerbations per patient per year at 52 weeks (NCT00514683)
Timeframe: 52 weeks

Pre-dose Plasma Concentration of Nintedanib in Plasma at Steady State on Day 365 (Cpre,ss,365) and Day 729 (Cpre,ss,729).

Cpre,ss,729 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 729 and Cpre,ss,365 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 365. At day 365, values only for Nintedanib 50 qd group are presented as no values reported for other groups and at day 729, values are presented for all group except for Nintedanib 50 qd group as no values reported for it. (NCT00514683)
Timeframe: day 365 and day 729

Rate of Decline in FVC

"Rate of decline in Forced Vital Capacity (FVC) evaluated from baseline until 52 weeks of treatment.~The means presents actually the adjusted rate based on a MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time." (NCT00514683)
Timeframe: Baseline until 52 weeks

Relative Change From Baseline in FVC

"Percent change from baseline in absolute Forced Vital Capacity (FVC) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region" (NCT00514683)
Timeframe: Baseline and 52 weeks

Relative Change From Baseline in FVC%Pred

"Percent change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region." (NCT00514683)
Timeframe: Baseline and 52 weeks

St George's Respiratory Questionnaire (SGRQ) Responder

St George's Respiratory Questionnaire (SGRQ) responder (<= -4 points change) (%) at 52 weeks-worst case (NCT00514683)
Timeframe: 52 weeks

Time to Progression

"Time to progression. Progression was defined as at least one of the following: 5mmHg increase in the alveolo-arterial pressure difference in oxygen (P(A-a)O2), 10% decrease in FVC (FVC(baseline)-FVC(progression) >= 10%) or Death.~Failure means participants with event and Censored means participants with no event." (NCT00514683)
Timeframe: 52 weeks

Absolute Change From Baseline in DLCO by Categories

"Absolute change from baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) by below mentioned categories:~Decrease > 15% or > 1~Change <= 15% or <= 1~Increase > 15% or > 1" (NCT00514683)
Timeframe: Baseline and 52 weeks

Absolute Change From Baseline in MRC Dyspnea Scale by Categories

"Absolute change from baseline in Medical Research Council (MRC) dyspnea scale by below mentioned categories:~Decrease~No Change~Increase" (NCT00514683)
Timeframe: Baseline and 52 weeks

Absolute Change From Baseline in P(A-a) O2 by Categories

"Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a) O2) by below mentioned categories:~Decrease > 4 mmHg~Change within +/- 4 mmHg~Increase > 4 mmHg" (NCT00514683)
Timeframe: Baseline and 52 weeks

Absolute Change From Baseline in PaO2 by Categories

"Absolute change from baseline in Arterial oxygen partial pressure (PaO2) by below mentioned categories:~Decrease > 4 mmHg~Change within +/- 4 mmHg~Increase > 4 mmHg" (NCT00514683)
Timeframe: Baseline and 52 weeks

Absolute Change From Baseline in SpO2 at Rest by Categories

"Absolute change from baseline in oxygen saturation (SpO2) at rest by below mentioned categories:~SpO2 (non-invasive) at 52 weeks:~Decrease > 4% SpO2~Change within +/- 4% SpO2~Increase > 4% SpO2" (NCT00514683)
Timeframe: Baseline and 52 weeks

Number of Participants With Change From Baseline in FVC by Categories

"Change from baseline in percentage of Forced Vital Capacity (FVC) at 52 weeks in below mentioned categories:~Decrease > 10% or 200mL~Change within <= 10% or <=200 mL~Increase > 10% or 200mL" (NCT00514683)
Timeframe: Baseline and 52 weeks

Survival (All Causes of Death and Lung-transplant Free)

"Survival (all causes of death and lung-transplant free) at 52 weeks, based on overall mortality and on-treatment survival.~Failure means participants with event and Censored means participants with no event." (NCT00514683)
Timeframe: 52 weeks

Survival (Death Due to Respiratory Cause, and Lung-transplant Free)

"Survival (death due to respiratory cause, and lung-transplant free) at 52 weeks.~Failure means participants with event and Censored means participants with no event." (NCT00514683)
Timeframe: 52 weeks

Time to First Occurrence of IPF Exacerbation

"This endpoint is called time to first occurrence of IPF exacerbation however it was actually analysed as the proportion of patients having occurrence of Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks.~Failure means participants with event and Censored means participants with no event." (NCT00514683)
Timeframe: 52 weeks

Absolute Change in Percent Predicted Forced Vital Capacity (FVC)

Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72. (NCT00287716)
Timeframe: From baseline up to 72 weeks

Change in Dyspnea Score

The mean change from baseline to week 72 in Dyspnea score was measured by the University of San Diego Shortness of Breath Questionnaire (UCSD SOBQ). The SOBQ is used to assess shortness of breath with various activities of daily living (for example, brushing ones teeth or mowing the lawn). Patients rated the severity of their shortness of breath experienced on an average day during the past week on a 6 point scale (0 to 5), with 0 = not at all breathless, 4= severely breathless and 5 = Maximally or unable to do because of breathlessness. (NCT00287716)
Timeframe: Baseline to Week 72

Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs

(NCT00287716)
Timeframe: Baseline to Week 72

Change in Six-Minute Walk Test (6MWT)Distance

The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test as measured in meters (m). (NCT00287716)
Timeframe: Baseline to Week 72

Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test

The change from baseline to week 72 in worst oxygen saturation during the 6-Minute Walk Test as measure by Pulse Oximetry (SpO2) Level is calculated as the simple difference between baseline SpO2 measurements and week 72 SpO2 measurements. (NCT00287716)
Timeframe: Baseline to Week 72

Worsening of Idiopathic Pulmonary Fibrosis (IPF)

"Worsening of IPF was defined by the occurrence of any of the following events:~Acute IPF exacerbation, IPF-related death, Lung transplantation, or Respiratory hospitalization." (NCT00287716)
Timeframe: Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.

Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC)

Based on the change in baseline percent predicted FVC at week 72, patients were assigned to 1 of 5 categories: mild decline (<10% but >=0% decline), moderate decline (<20% but >=10% decline), severe decline (>=20% decline), mild improvement (>0% but <10% improvement), or moderate improvement (>=10% improvement). Those who died or had a lung transplant before Week 72 were included in the severe decline category. The results indicate the number of patients who experienced a Categorical Change in Percent Predicted Forced Vital Capacity. (NCT00287716)
Timeframe: baseline up to 72 weeks

Progression-free Survival (PFS)

Progression is defined as the first occurrence of a 10% absolute decline from baseline in percent predicted Forced Vital Capacity, a 15% absolute decline from baseline in percent predicted hemoglobin(Hgb)-corrected carbon monoxide diffusing capacity (DLco), or, death. (NCT00287716)
Timeframe: Baseline to Week 72

Diffusing Capacity for Carbon Monoxide (DLCO) % Predicted Values

Interstitial changes associated with IPF can worsen diffusing capabilities across the alveolar-capillary membrane. As a result, diffusing capacity of carbon monoxide is an important outcome to assess architectural distortion and resultant decrements in diffusing capabilities (NCT01214187)
Timeframe: Baseline to Week 12

Serum MMP7 Level

The primary study endpoint was the change in MMP7 serum concentration (ng/ml) from baseline to 12 weeks. Serum MMP7 concentrations in peripheral blood are easily measureable and reflect changes in the alveolar microenvironment. Thus, we have chosen to study mean serum MMP7 concentrations after three months of CO treatment as a surrogate biomarker of the effect of inhaled CO administration on disease progression. (NCT01214187)
Timeframe: Baseline to Week 12

Six Minute Walk Distance

The six minute walk distance is commonly used both in research studies and in clinical practice as a measure of functional capabilities, and changes in six minute walk distance and oxygen use during testing over time often reflect clinically relevant disease progression. We will measure the distance travelled during six minutes (meters) in accordance with published guidelines (NCT01214187)
Timeframe: Baseline to Week 12

St George's Respiratory Questionnaire

St. George's Respiratory Questionnaire (SGRQ) is a validated self-reported instrument. In this instrument, scores range from 0 to 100, with higher scores reflective of worse quality of life. (NCT01214187)
Timeframe: Baseline to Week 12

Total Lung Capacity % Predicted Values (TLC)

Total lung capacity % predicted values (TLC) is a major clinical determinant of restrictive lung disease in practice, with TLC measurement below the 5th percentile of the predicted value indicative of a restrictive ventilatory defect (NCT01214187)
Timeframe: Baseline to Week 12

Change in 6MWT at Week 48

The 6MWT is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. (NCT00768300)
Timeframe: Baseline and Week 48

Change in DLCO % Predicted at Week 48

DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood. DLCO % predicted is defined as DLCO % of the participant divided by the average DLCO % in the population for any person of similar age, sex and body composition. (NCT00768300)
Timeframe: Baseline and Week 48

Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI)

The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A TDI score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests. (NCT00768300)
Timeframe: Baseline and Week 48

Change in FVC % Predicted at Week 48

FVC is defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted is defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition. (NCT00768300)
Timeframe: Baseline and Week 48

Percentage of Participants Who Developed PH on Study

The percentage of participants known to have developed pulmonary hypertension on study documented by right heart catheterization (RHC) was analyzed. RHC was done at baseline and 48 weeks, or at the early termination visit. (NCT00768300)
Timeframe: Up to 48 weeks

Proportion of Participants With No Disease Progression or Death at 48 Weeks

The proportion of participants with no disease progression or death is presented as a percentage using a Kaplan-Meier (KM) estimate of survival or not experiencing disease progression. (NCT00768300)
Timeframe: Baseline and Week 48

Time to Death or Disease (IPF) Progression.

"The median time to death or disease progression was based on Kaplan-Meier (KM) estimates of pooling over strata, and was defined as the first occurrence of any of the following:~Either 1) a decrease of ≥ 10% in FVC (L) and a decrease of ≥ 5% in diffuse lung capacity for carbon monoxide (DLCO) (ml/min/mmHg), or 2) a decrease of ≥ 5% in FVC (L) and a decrease of ≥ 15% in DLCO (ml/min/mmHg); deterioration in FVC and DLCO must be confirmed at the subsequent visit within 28 (± 14) days~Respiratory hospitalization (hospitalization involving worsening of, or deterioration in respiratory symptoms, gas exchange/hypoxemia, or radiographic findings on chest x-ray or high-resolution computerised tomography (HRCT) scan~All-cause mortality" (NCT00768300)
Timeframe: Up to 48 months

Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36)

The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state. (NCT00768300)
Timeframe: Baseline and Week 48

Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George's Respiratory Questionnaire (SGRQ)

The SGRQ is designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airways disease. The range of each score is 0-100, with 0 indicating fewer limitations and 100 indicating more limitations; an increase in score indicates an increase in limitations. (NCT00768300)
Timeframe: Baseline and Week 48

Reviews

3 reviews available for carbon monoxide and Cryptogenic Fibrosing Alveolitis

Trials

8 trials available for carbon monoxide and Cryptogenic Fibrosing Alveolitis

Other Studies

49 other studies available for carbon monoxide and Cryptogenic Fibrosing Alveolitis