Trial · NCT00458341
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total Chloride Transport at Day 14 of Cycles 1 and 2 | Baseline of Cycle 1 and Cycle 2, Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days) | All randomized participants who received at least 1 dose of study drug and had evaluable chloride transport data. | millivolts (mV) | MEAN |
| PRIMARY | Number of Participants With a Chloride Transport Response at Day 14 of Cycles 1 and 2 | Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days) | All randomized participants who received at least 1 dose of study drug and had evaluable chloride transport response data. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Normalization of Chloride Transport Between Baseline and Day 14 of Cycles 1 and 2 | Overall Baseline and Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days) | All randomized participants who received at least 1 dose of study drug and had evaluable normalization of chloride transport data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Parameters of Transepithelial Difference at Day 14 of Cycles 1 and 2 | Baseline of Cycle 1 and Cycle 2, Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days) | All randomized participants who received at least 1 dose of study drug and had evaluable transepithelial difference data. | mV | MEAN |
| SECONDARY | Change From Baseline in CFTR Protein in Nasal Mucosa as Determined by Immunofluorescence at Overall Day 56 | Overall Baseline, Overall Day 56 | All randomized participants who received at least 1 dose of study drug and had evaluable apical cell data. | percentage of apical cells | MEAN |
| SECONDARY | Change From Baseline in Nonsense Mutation CFTR mRNA in Nasal Mucosa as Determined by Quantitative Real-Time Polymerase Chain Reaction (RT-PCR) Assay at Overall Day 42 | Overall Baseline, Overall Day 42 | All randomized participants who received at least 1 dose of study drug and had evaluable CFTR mRNA data. | ||
| SECONDARY | Change From Baseline in Pulmonary Function as Measured by Spirometry at Day 14 or 15 of Cycles 1 and 2 and Overall Day 56 | Overall Baseline, Day 14 or 15 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56 | All randomized participants who received at least 1 dose of study drug and had evaluable pulmonary function data. | percent of predicted | MEAN |
| SECONDARY | Change From Baseline in Sputum Markers of Inflammation (Free Elastase) at Day 14 or 15 of Cycles 1 and 2 and Overall Day 56 | Overall Baseline, Day 14 or 15 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56 | All randomized participants who received at least 1 dose of study drug and had evaluable sputum markers of inflammation data. | micrograms/milliliters (μg/mL) | MEAN |
| SECONDARY | Change From Baseline in Sputum Markers of Inflammation (Matrix Metalloproteinase 9 [MMP-9] Active) at Day 14 or 15 of Cycles 1 and 2 and Overall Day 56 | Overall Baseline, Day 14 or 15 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56 | All randomized participants who received at least 1 dose of study drug and had evaluable sputum markers of inflammation data. | nanograms/milliliter (ng/mL) | MEAN |
| SECONDARY | Change From Baseline in Sputum Markers of Inflammation (Tumor Necrosis Factor-Alpha [TNF-α], Interleukin-8 [IL-8], Transforming Growth Factor Beta 1 [TGF-β1]) at Day 14 or 15 of Cycles 1 and 2 and Overall Day 56 | Overall Baseline, Day 14 or 15 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56 | All randomized participants who received at least 1 dose of study drug and had evaluable sputum markers of inflammation data. | picograms/milliliter (pg/mL) | MEAN |
| SECONDARY | Change From Baseline in Sputum Markers of Inflammation (Uridine-5'-Triphosphate [UTP]) at Day 14 or 15 of Cycles 1 and 2 and Overall Day 56 | Overall Baseline, Day 14 or 15 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56 | All randomized participants who received at least 1 dose of study drug and had evaluable sputum markers of inflammation data. | milligrams/deciliter (mg/dL) | MEAN |
| SECONDARY | Change From Baseline in Clinically Significant Neutrophil Levels in Blood at Day 14 or 15 of Cycles 1 and 2 and Overall Day 56 | Overall Baseline, Day 14 or 15 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56 | All randomized participants who received at least 1 dose of study drug and had evaluable data of neutrophil levels in blood. | 10^9/liters | MEAN |
| SECONDARY | Change From Baseline in Clinically Significant Serum Levels of C-Reactive Protein at Day 14 or 15 of Cycles 1 and 2 and Overall Day 56 | Overall Baseline, Day 14 or 15 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56 | All randomized participants who received at least 1 dose of study drug and had evaluable serum levels of C-reactive data. | milligrams/liter (mg/L) | MEAN |
| SECONDARY | Change From Baseline in Body Weight at Day 14 or 15 of Cycles 1 and 2 and Overall Day 56 | Overall Baseline, Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56 | All randomized participants who received at least 1 dose of study drug and had evaluable body weight data. | kg | MEAN |
| SECONDARY | Change From Baseline in the CF-Related Symptom Scores, as Assessed Using a Participant-Reported Questionnaire at Day 14 of Cycles 1 and 2 and Overall Day 56 | Overall Baseline, Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days), and Overall Day 56 | All randomized participants who received at least 1 dose of study drug and had evaluable CF-related symptom scores. | scores on a scale | MEDIAN |
| SECONDARY | PK: Area Under the Concentration Time Curve From Time 0 (Dosing) to 24 Hours (AUC0-24) of Ataluren | 0 (predose), 2 and 3 hours postdose of the morning dose; 0 (predose), 2 and 3 hours postdose of the midday dose; and 0 hours (predose), 2, 3, and 12 hours postdose of the evening dose on Day 14 of Cycle 1 and Cycle 2 | All randomized participants who received at least 1 dose of study drug and had evaluable AUC0-24 data. The data for each dose level represents pooled data for participants in the low-to-high dose sequence and the high-to-low dose sequence. | microgram*hours/milliliter (μg*h/mL) | MEAN |
| SECONDARY | Compliance With Study Treatment | Baseline up to Day 14 in Cycle 1 and Cycle 2 | All randomized participants who received at least 1 dose of study drug and had evaluable compliance data. The data for each dose level represents pooled data for participants in the low-to-high dose sequence and the high-to-low dose sequence. | percentage of doses | MEDIAN |
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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