Trial · NCT03711162
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annual Rate of Decline in FVC up to Week 52 | Baseline up to week 52 | FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. |
| Secondary | Percentage of Participants With Disease Progression up to Week 52 | Up to week 52 | Disease progression was defined as the composite occurrence of more than or equal to (\>=)10 percent (%) absolute decline in percent predicted forced vital capacity (%FVC) or all-cause mortality. FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. |
| Secondary | Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS) | Up to EoS (week 121) | Percentage of participants with respiratory related hospitalization were reported in this measure. |
| Secondary | Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 | Baseline, week 52 | SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms score assessing the frequency and severity of respiratory symptoms (Items 1-8), activity score assessing the effects of breathlessness on mobility and physical activity (Items 11-17 and 36 to 44), and impacts score assessing the psychosocial impact of the disease (Items 9-10, 18-35 and 45-50). Each item has a specific weight. Domain scores = 100 \* summed weights from positive items in that component/sum of maximum weights for all non-missing items in that component Total score = 100 \* summed weights from positive items in the questionnaire/sum of maximum weights for all non-missing items in the questionnaire Scores were weighted such that each domain score ranged from 0 to 100 and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL. |
| Secondary | Annual Rate of Decline in FVC Until EoS | Baseline up to EoS (week 121) | FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. |
| Secondary | Percentage of Participants With Disease Progression Until EoS | Up to EoS (week 121) | Disease progression was defined as the composite occurrence of \>=10% absolute decline in percent predicted %FVC or all-cause mortality. FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. |
| Secondary | Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 100 | Baseline, week 100 | SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms score assessing the frequency and severity of respiratory symptoms (Items 1-8), activity score assessing the effects of breathlessness on mobility and physical activity (Items 11-17 and 36 to 44), and impacts score assessing the psychosocial impact of the disease (Items 9-10, 18-35 and 45-50). Each item has a specific weight. Domain scores = 100 \* summed weights from positive items in that component/sum of maximum weights for all non-missing items in that component Total score = 100 \* summed weights from positive items in the questionnaire/sum of maximum weights for all non-missing items in the questionnaire Scores were weighted such that each domain score ranged from 0 to 100 and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL. |
| Secondary | Percentage of Participants With All Cause Hospitalization Until EoS | Up to EoS (week 121) | Percentage of participants with all cause hospitalization was reported for this measure. |
| Secondary | Percentage of Participants With Respiratory Related Mortality Until EoS | Up to EoS (week 121) | Percentage of participants with respiratory related mortality until EoS were reported for this study. |
| Secondary | Percentage of Participants Hospitalized for Non-elective Lung Transplant Until EoS | Up to EoS (week 121) | Percentage of Participants who were hospitalized for Non-elective lung transplant were reported for this measure. |
| Secondary | Percentage of Participants With Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation Until EoS | Up to EoS (week 121) | Percentage of participants with acute IPF exacerbation until EoS were reported for this measure. |
| Secondary | Percentage of Participants With All Cause Mortality or Hospitalization for Non-elective Lung Transplant Until EoS | Up to EoS (week 121) | Percentage of participants with all-cause mortality or hospitalization for non-elective lung transplant were reported for this measure. |
| Secondary | Percentage of Participants With All Cause Mortality, Hospitalization for Non-elective Lung Transplant or Hospitalization for Qualifying for Lung Transplant Until EoS | Up to EoS (week 121) | Percentage of participants with all-cause mortality or hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant were reported for this measure. |
| Secondary | Percentage of Participants With All-Cause Mortality or Hospitalization That Meets >=10% Absolute Decline in %FVC or Respiratory-Related Hospitalization Until EoS | Up to EoS (week 121) | Percentage of participants with all-cause mortality or respiratory related hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization were reported for this measure. |
| Secondary | Percentage of Participants With All-Cause Mortality or Respiratory-Related Hospitalizations Until EoS | Up to EoS (week 121) | Percentage of participants with all-cause mortality or respiratory related hospitalization were reported for this measure. |
| Secondary | FVC at Week 52 | Week 52 | FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. |
| Secondary | Change From Baseline in FVC at Week 52 | Baseline, week 52 | FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. |
| Secondary | Percent Change From Baseline in FVC at Week 52 | Baseline, week 52 | FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. |
| Secondary | FVC at Week 112 | Week 112 | FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. |
| Secondary | Change From Baseline in FVC at Week 112 | Baseline, week 112 | FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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