Trial · NCT03000348
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Sputum Bacterial Load | Baseline through Day 21/End of Study | Intention to treat population | log 10 cfu/ml | MEAN |
| PRIMARY | Safety and Tolerability Assessed by the Number of Subjects With Adverse Events | Baseline through Day 21/End of Study | Summary of participant reported adverse events (AEs) by study group | participants | NUMBER |
| SECONDARY | Change From Baseline in Neutrophil Elastase Levels | Baseline through Day 21/End of Study | Neutrophil Elastase Levels by Visit - Covariate Adjusted ANCOVA with Observed Data ITT Population | ng/mL | MEAN |
| SECONDARY | Change From Baseline in Sputum IL8 | Baseline through Day 21/End of Study | ITT Population | pg/mL | MEAN |
| SECONDARY | Change From Baseline in FEV1 | Baseline through Day 21/End of Study | Change from Baseline in FEV1 Percent Predicted (%) - Covariate Adjusted ANCOVA with Observed Data ITT Population | percentage of predicted | MEAN |
| SECONDARY | Change From Baseline in BMI | Baseline through Day 21/End of Study | ITT | kg/m^2 for BMI | MEAN |
| SECONDARY | Change From Baseline in C-Reactive Protein | Baseline through Day 21 | CRP by visit ANCOVA with observed data ITT population | nmol/L | MEAN |
| SECONDARY | Change From Baseline in Blood Leukocyte Count | Baseline through Day 21/End of Study | ITT | 10^9 leucocytes/L | MEAN |
| SECONDARY | Assessment of Blood Cysteamine Levels | Day 14 | Safety population | ng/ml | MEAN |
| SECONDARY | Assessment of Sputum Cysteamine Levels | Day 14 | Safety Population - there are fewer numbers of patients due to the inability of some patients to provide sputum samples | ng/ml | MEAN |
| SECONDARY | Change From Baseline in CFRSD-CRISS | Baseline through to Day 21 | Mean Change from Baseline in CRFSD-CRISS - Linear MMRM Model with Observed Data (ITT Population) | units on a scale | MEAN |
| SECONDARY | Change From Baseline in CFQ-R | Baseline through Day 21/End of Study | Change from Baseline to Day 14 in CFQ-R Respiratory Score: ANCOVA with Observed Data ITT Population | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Jarad and Sequeiros Symptom Score Questionnaire | changes from baseline at day 7 and day 14 | ITT Linear MMRM Model with Observed Data | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Weight | Baseline through Day 21/End of Study | ITT | kg | MEAN |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03000348/outcomes