Trial · NCT03000348
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Sputum Bacterial Load | Baseline through Day 21/End of Study | Change from baseline through to Day 21 in log10 cfu/ml transformed total gram negative sputum bacterial load |
| Primary | Safety and Tolerability Assessed by the Number of Subjects With Adverse Events | Baseline through Day 21/End of Study | Assessed by variables such as adverse events (AEs), laboratory assessments, physical examinations, and vital signs. |
| Secondary | Change From Baseline in Neutrophil Elastase Levels | Baseline through Day 21/End of Study | Actual values and change from baseline in neutrophil elastase levels were summarized using descriptive statistics by visit for each treatment group and each TDD group for the ITT Population. |
| Secondary | Change From Baseline in Sputum IL8 | Baseline through Day 21/End of Study | Sputum IL-8 Levels by Visit - Covariate Adjusted ANCOVA with Observed Data ITT Population |
| 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 |
| Secondary | Change From Baseline in BMI | Baseline through Day 21/End of Study | BMI (kg/m\^2) by Visit - ANCOVA with Observed Data ITT Population |
| Secondary | Change From Baseline in C-Reactive Protein | Baseline through Day 21 | Change from baseline in C-Reactive Protein at visits 7, 14 and 21 |
| Secondary | Change From Baseline in Blood Leukocyte Count | Baseline through Day 21/End of Study | Blood Leukocyte Count (10\^9 leucocytes/L) by Visit - ANCOVA with Observed Data ITT Population |
| Secondary | Assessment of Blood Cysteamine Levels | Day 14 | Study Drug Plasma at Day 14 Safety Population |
| Secondary | Assessment of Sputum Cysteamine Levels | Day 14 | Study Drug Sputum Concentrations at Day 14 Safety Population |
| Secondary | Change From Baseline in CFRSD-CRISS | Baseline through to Day 21 | Mean Change from Baseline in Cystic Fibrosis Respiratory Symptom Diary (CFRSD)-Chronic Respiratory Infection Symptom Scale (CRISS) CRFSD-CRISS:The CFRSD is a 16-item PROM to evaluate the effect of treatment on the severity of symptoms of acute respiratory infections associated with CF (i.e., CFRSD-CRISS) and to assess the emotional and activity impacts of these symptoms. The overall CRISS score range is 0-100 with 100 being the most severe symptoms.The CFRSD-CRISS is a validated unidimensional scale based on a subset of 8 items from the CFRSD questionnaire that quantifies symptom severity for the previous 24 hours to capture the magnitude of symptoms in stable CF, during medically treated CF exacerbations, and during recover from an exacerbation. The 8 items on the CFRSD-CRISS were scored using a 5-point Likert scale ranging from 0 (no symptom) to 4 (the highest magnitude of severity). So score range of 0-32. |
| Secondary | Change From Baseline in CFQ-R | Baseline through Day 21/End of Study | The CFQ-R is a disease-specific HRQOL (Health related quality of life) measure containing both generic and CF-specific scales and measures functioning during the previous 2 weeks. Each CFQ-R scale yielded standardized scores ranging from 0 to 100; higher scores indicated better HRQOL |
| Secondary | Change From Baseline in Jarad and Sequeiros Symptom Score Questionnaire | changes from baseline at day 7 and day 14 | The Jarad and Sequeiros Symptom Questionnaire (Jarad, 2012) is a simple participant-completed questionnaire that assesses and evaluates change in participant symptoms related to different aspects of respiratory function during a CF exacerbation. The questionnaire consists of 4 questions, each answered on a 4-point scale ranging from 1 (best) to 4 (worst). A range of minimum 4 to maximum16.Jarad and Sequeiros Questionnaire Score - changes from baseline at day 7 and day 14 |
| Secondary | Change From Baseline in Weight | Baseline through Day 21/End of Study | Weight (kg) by visit - ANCOVA with observed 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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