Trial · NCT02497937
Outcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Diffusing Capacity of the Lung for Carbon Monoxide (DLco) on Pulmonary Gas Transfer (Site: Mayo) | Baseline, Day 4, Day 5 and Day 7 of each treatment period | Analysis Population comprised of participants in the 'All Subjects' population having Baseline and post-Baseline assessments of the endpoint of interest for both periods. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | mL/mmHg/min | MEAN |
| PRIMARY | Change From Baseline in the Diffusing Capacity of the Lung for DLco on Pulmonary Gas Transfer (Site: Hennepin) | Baseline, Day 4, Day 5 and Day 7 of each treatment period | Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | mL/mmHg/min | MEAN |
| SECONDARY | Change From Baseline in Diffusing Capacity of the Lung for Nitric Oxide (DLno) and Membrane Conductance (DM) | Baseline, Day 4, Day 5 and Day 7 of each treatment period | Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | mL/mmHg/min | MEAN |
| SECONDARY | Change From Baseline in Capillary Blood Volume (Vc) | Baseline, Day 4, Day 5 and Day 7 of each treatment period | Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | mL | MEAN |
| SECONDARY | Change From Baseline in DLco Following Exercise and Following an Intravenous Saline Infusion (Site: Mayo) | Baseline, Day 5 and Day 7 of each treatment period | Analysis Population. | mL/mmHg/min | MEAN |
| SECONDARY | Change From Baseline in DLco Following Exercise and Following an Intravenous Saline Infusion (Site: Hennepin) | Baseline, Day 5 and Day 7 of each treatment period | Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | mL/mmHg/min | MEAN |
| SECONDARY | Change From Baseline in the Ventilation/Volume of Carbon Dioxide Production (VE/VCO2) Ratio | Baseline and Day 7 of each treatment period | Analysis Population | Ratio | MEAN |
| SECONDARY | Change From Baseline in Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 Second (FEV1), Forced Expiratory Flows (FEF) 25-75, FEF50 and FEF75 | Baseline, Day 4 and Day 7 of each treatment period | Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Liters | MEAN |
| SECONDARY | Change From Baseline in Functional Residual Capacity (FRC) | Baseline, Day 4 and Day 7 of each treatment period | Analysis Population. Analysis was planned but not performed. FRC parameter was not collected because other measures which were collected served as reasonable surrogates. | ||
| SECONDARY | Change From Baseline in End-expiratory Lung Volume (EELV) Measured by Body Plethysmograph | Baseline, Day 4 and Day 7 of each treatment period | Analysis Population. Analysis was planned but not performed. EELV parameter was not collected because other measures which were collected served as reasonable surrogates. | ||
| SECONDARY | Change From Baseline in Dyspnea Score | Baseline, Day 5 and Day 7 of each treatment period | Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Scores on a scale | MEAN |
| SECONDARY | Respiratory Rate Over Time Continuously Measured by Body Sensor (Site: Mayo Only) | Up to Day 7 of each treatment period | All Subjects population comprised of all randomized participants who received at least one dose of study medication. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | breaths per minute | MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure(SBP) and Diastolic Blood Pressure (DBP) | Baseline and up to Day 7 of each treatment period | All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Millimeters of mercury | MEAN |
| SECONDARY | Change From Baseline in Heart Rate | Baseline and up to Day 7 of each treatment period | All Subjects population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | beats per minute | MEAN |
| SECONDARY | Change From Baseline in Respiration Rate | Baseline and up to Day 7 of each treatment period | All Subjects population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | breaths per minute | MEAN |
| SECONDARY | Change From Baseline in Temperature | Baseline and up to Day 7 of each treatment period | All Subjects population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Celsius | MEAN |
| SECONDARY | Change From Baseline in Percent Oxygen in Blood | Baseline and up to Day 7 of each treatment period | All Subjects population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Percentage of oxygen | MEAN |
| SECONDARY | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Up to Day 7 in each treatment period | All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) Values | Baseline and up to Day 7 in each treatment period | All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | International units per liter | MEAN |
| SECONDARY | Change From Baseline in Albumin and Total Protein Values | Baseline and up to Day 7 of each treatment period | All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Grams per liter | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
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GET https://conductscience.org/api/trials/v1/NCT02497937/outcomes