Trial · NCT00737100
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 | Percent Predicted FEV1 AUC0-4 Response at the End of Week 12 | Baseline, Week 12 | Outcome measure description: Change from baseline in percent predicted Forced Expiratory Volume in one second (FEV1) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline. |
| Primary | Percent Predicted FEV1 Trough Response at the End of Week 12 | Baseline, Week 12 | Outcome measure description: Change from baseline in percent predicted trough Forced Expiratory Volume in one second. Calculated as percent predicted at week 12 minus percent predicted at baseline. |
| Secondary | Percent Predicted FVC AUC0-4 Response at the End of Week 12 | Baseline, Week 12 | Change from baseline in percent predicted Forced Vital Capacity (FVC) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline. |
| Secondary | Percent Predicted FVC Trough Response at the End of Week 12 | Baseline, Week 12 | Change from baseline in percent predicted trough Forced Vital Capacity (FVC). Calculated as percent predicted at week 12 minus percent predicted at baseline. |
| Secondary | Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12 | Baseline, Week 12 | Forced Expiratory Flow at 25-75% of vital capacity (FEF25-75). Calculated as percent predicted at week 12 minus percent predicted at baseline. |
| Secondary | Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12 | Baseline, Week 12 | Change from baseline in static lung hyperinflation as measured by RV/TLC. Calculated as percent predicted at week 12 minus percent predicted at baseline. |
| Secondary | Respiratory and Systemic Symptoms Questionnaire (RSSQ) | 12 weeks | Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period. |
| Secondary | Change From Baseline in CFQ Scores - Adult Group | 12 weeks | The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adults with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health. |
| Secondary | Change From Baseline in CFQ Scores - Adolescents Group | 12 weeks | The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents (age 6-13) with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health. |
| Secondary | Change From Baseline in CFQ Scores - Parent Questionnaire | 12 weeks | The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents with CF - parent questionnaire. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health. |
| Secondary | Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss) | pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose | Ae0-4,ss represents the amount of tiotropium that is eliminated in urine from time 0 to 4 hours at steady state |
| Secondary | Maximum Measured Concentration at Steady State (Cmax,ss) | pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose | Cmax,ss represents the maximum measured concentration of tiotropium in plasma at steady state. |
| Secondary | Time From Dosing to the Maximum Concentration (Tmax,ss) | pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose | Tmax,ss represents the time from dosing to the maximum concentration of tiotropium in plasma |
| Secondary | Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation | From first drug administration until 30 days after last drug administration (up to 121 days) | Clinical Relevant Abnormalities for Vital Signs and Laboratory evaluation. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Event. |
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.
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GET https://conductscience.org/api/trials/v1/NCT00737100/registered