Trial · NCT00803205
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Predicted Function (Percent-Predicted) of Forced Expiratory Volume in One Second (FEV1) at Baseline | Baseline (Week 1) | The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, 'Number analyzed' signifies participants evaluable for this outcome measure. | percentage of predicted FEV1 | MEAN |
| PRIMARY | Percentage Change From Baseline in Percent-Predicted of FEV1 at Week 48 | End of Treatment (EOT) (Week 48) | The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, 'Number analyzed' signifies participants evaluable for this outcome measure. | percent change | MEAN |
| SECONDARY | Rate of Pulmonary Exacerbations as Defined by Modified Fuch's Criteria Over 48 Weeks | Baseline to EOT (Week 48) | The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, 'Number analyzed' signifies participants evaluable for this outcome measure. | exacerbations | MEAN |
| SECONDARY | Change From Baseline in Awake Cough Hourly Rate at Week 48 | Baseline, EOT (Week 48) | The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, 'Number analyzed' signifies participants evaluable for this outcome measure. | coughs/hour | MEAN |
| SECONDARY | Change From Baseline in the Respiratory Domain Score of the Revised Cystic Fibrosis Questionnaire (CFQ-R) at Week 48 | Baseline, EOT (Week 48) | The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, 'Number analyzed' signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Percent-Predicted of Forced Vital Capacity (FVC) at Baseline | Baseline (Week 1) | The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, 'Number analyzed 'signifies participants evaluable for this outcome measure. | percentage of predicted FVC | MEAN |
| SECONDARY | Percentage Change From Baseline in Percent-Predicted of FVC at Week 48 | EOT (Week 48) | The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, 'Number analyzed 'signifies participants evaluable for this outcome measure. | percent change | MEAN |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) | Baseline up to 4 Weeks Post-Treatment (Week 52) or Premature Discontinuation (PD) | The As-Treated Population: all randomized participants who received at least 1 dose of study drug. | percent of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Rate of Study Drug Compliance by Drug Accountability | Baseline up to EOT (Week 48) | The As-Treated Population: all randomized participants who received at least 1 dose of study drug. | percent of doses taken | MEDIAN |
| OTHER_PRE_SPECIFIED | Rate of Study Drug Compliance by Patient-Reported Data | Baseline up to EOT (Week 48) | The As-Treated Population: all randomized participants who received at least 1 dose of study drug. | percent of doses taken | MEDIAN |
| OTHER_PRE_SPECIFIED | Concentration of Ataluren | Predose and 2 Hours Postdose at Week 1, Week 16, Week 32, EOT (Week 48) | The As-Treated Population: all randomized participants who received at least 1 dose of study drug. | micrograms/milliliter (ug/mL) | MEDIAN |
| OTHER_PRE_SPECIFIED | Rate of Interventions for Respiratory Symptoms | Baseline up to EOT (Week 48) | The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, 'Number analyzed' signifies participants evaluable for specified categories. | days with interventions per study | MEAN |
| OTHER_PRE_SPECIFIED | Rate of Disruptions in Activities of Daily Living Because of Pulmonary Symptoms | Baseline up to EOT (Week 48) | The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, 'Number analyzed' signifies participants evaluable for specified categories. | days with disruptions per study | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Body Weight at Week 48 | Baseline, EOT (Week 48) | The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, 'Number analyzed' signifies participants evaluable for this outcome measure. | kg | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in the Concentration of Interleukin-8 (IL-8) in Serum and Sputum at Week 48 | Baseline, EOT (Week 48) | The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, 'Number analyzed' signifies participants evaluable for this outcome measure. | picograms/mL | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in the Concentration of Neutrophil Elastase in Sputum at Week 48 | Baseline, EOT (Week 48) | The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, 'Number analyzed' signifies participants evaluable for this outcome measure. Twenty-two participants each in the ataluren and placebo groups were not evaluable. | ug/mL | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in the Concentration of C-Reactive Protein (CRP) in Serum at Week 48 | Baseline, EOT (Week 48) | The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, 'Number analyzed' signifies participants evaluable for this outcome measure. | mg/liter (L) | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in the Total Lung Score as Assessed by Computed Tomography (CT) at Week 48 | Baseline, EOT (Week 48) | The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, 'Number analyzed' signifies participants evaluable for this outcome measure. Eleven and 10 participants in the ataluren and placebo groups, respectively, were not evaluable. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Total Nasal Chloride Transport as Assessed by Transepithelial Potential Difference (TEPD) at Week 48 | Baseline, EOT (Week 48) | The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, 'Number analyzed' signifies participants evaluable for this outcome measure. | millivolts | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Sweat Chloride Concentration at Week 48 | Baseline, EOT (Week 48) | The ITT Population: all randomized participants with data for FEV1 at Baseline and a minimum of 1 post-Baseline assessment before Week 8. Here, 'Number analyzed' signifies participants evaluable for this outcome measure. Two and 5 participants in the ataluren and placebo groups, respectively, were not evaluable. | millimoles/L | 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
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