Trial · NCT07520110
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to death, non-elective hospitalization, or lung transplantation | Baseline (visit 1) to up to 24 months | Clinical composite measure defined as the time from randomization to the first occurrence of any of its three components: all-cause mortality, first unplanned (non-elective) hospitalization, or lung transplantation. |
| Secondary | Time to all-cause mortality | Baseline (visit 1) to up to 24 months | The time from randomization to death from any cause. |
| Secondary | Time to first non-elective hospitalization | Baseline (visit 1) to up to 24 months | The time from randomization to the first unplanned inpatient hospital admission |
| Secondary | Time to lung transplantation | Baseline (visit 1) to up to 24 months | The time from randomization to the date of a participant's lung transplant |
| Secondary | Time to respiratory hospitalization | Baseline (visit 1) to up to 24 months | The time from randomization to the first non-elective respiratory hospitalization. Non-elective respiratory hospitalizations specifically refer to unplanned admissions where the primary cause is a pulmonary condition, as determined by a blinded adjudication committee. |
| Secondary | Change in Forced Vital Capacity (FVC) | Baseline (visit 1) to 12 months | The longitudinal change in forced vital capacity (measured in liters) based on spirometry from baseline (visit 1) to 12 months. |
| Secondary | Change in Forced Vital Capacity (FVC) % Predicted | Baseline (visit 1) to 12 months | The longitudinal change in FVC% predicted based on spirometry from baseline (visit 1) to 12 months. |
| Secondary | Change in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) corrected for hemoglobin. | Baseline (visit 1) to 12 months. | Units - ml/(min\*mmHg) |
| Secondary | Change in Six-Minute Walk Distance (6MWD) | Baseline (visit 1) to 12 months | The longitudinal change in the maximum distance (in meters) a participant can walk on a flat surface in six minutes. |
| Secondary | Change in patient reported outcomes scores for the Living with Pulmonary Fibrosis (L-PF) Impacts Questionnaire | Baseline (visit 1) to 12 months | The L-PF Impacts module contains 21 items (5-point Likert scale) that assesses the impact of disease on patients with pulmonary fibrosis. The range of the total score is 0-100, with higher scores indicating greater symptom severity. |
| Secondary | Change in patient reported outcomes scores for the Living with Pulmonary Fibrosis (L-PF) Impacts Questionnaire | Baseline (visit 1) to 24 months | The L-PF Impacts module contains 21 items (5-point Likert scale) that assesses the impact of disease on patients with pulmonary fibrosis. The range of the total score is 0-100, with higher scores indicating greater symptom severity. |
| Secondary | Change in patient reported outcomes scores for the Living with Pulmonary Fibrosis (L-PF) Symptoms Questionnaire | Baseline (visit 1) to 12 months | The L-PF Symptoms modules contains contains 23 items (5-point Likert scale) that assesses shortness of breath, cough, and fatigue within the last 24 hours. The range of the total score is 0-100, with higher scores indicating greater symptom severity. |
| Secondary | Change in patient reported outcomes scores for the Living with Pulmonary Fibrosis (L-PF) Symptoms Questionnaire | Baseline (visit 1) to 24 months | The L-PF Symptoms modules contains contains 23 items (5-point Likert scale) that assesses shortness of breath, cough, and fatigue within the last 24 hours. The range of the total score is 0-100, with higher scores indicating greater symptom severity. |
| Secondary | Change in patient reported outcomes scores for the R-Scale-PF | Baseline (visit 1) to 12 months | The R-Scale-PF is a 5-item numerical rating scale (NRS) to allow for rapid assessment of symptoms and health related quality of life (HRQoL). Scores range from 0 to 50, with lower scores indicating a better HRQoL. |
| Secondary | Change in patient reported outcomes scores for the R-Scale-PF | Baseline (visit 1) to 24 months | The R-Scale-PF is a 5-item numerical rating scale (NRS) to allow for rapid assessment of symptoms and health related quality of life (HRQoL). Scores range from 0 to 50, with lower scores indicating a better HRQoL. |
| Secondary | Change in Fatigue Severity Scale Score | From baseline (visit 1) to 12 months | The Fatigue Severity Scale (FSS) is a nine-item questionnaire used to assess the impact of fatigue on an individual's daily life. The FSS is a self-report measure about their level of fatigue on a scale of 1 to 7, with 7 indicating a higher level of fatigue. |
| Secondary | Change in Fatigue Severity Scale Score | Baseline (visit 1) to 24 months | The Fatigue Severity Scale (FSS) is a nine-item questionnaire used to assess the impact of fatigue on an individual's daily life. The FSS is a self-report measure about their level of fatigue on a scale of 1 to 7, with 7 indicating a higher level of fatigue. |
| Secondary | Rate of non-elective hospitalization | Baseline (visit 1) to 12 months | The rate of all non-elective hospitalizations from baseline (visit 1) to 12 months (number of hospitalizations per year). |
| Secondary | Rate of non-elective hospitalization from baseline to 24 months | Baseline (visit 1) to 24 months | The rate of all non-elective hospitalizations from baseline (visit 1) to 24 months (number of hospitalizations per year). |
| Secondary | Rate of Respiratory Hospitalizations | Baseline (visit 1) to 12 months | The rate of all non-elective respiratory hospitalizations from baseline (visit 1) to 12 months (number of hospitalizations per year). Non-elective respiratory hospitalizations will be defined as any unplanned inpatient hospitalizations for which the primary cause was a pulmonary condition, in the opinion of the blinded adjudicators and based on all available clinical data. |
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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