Trial · NCT00669331
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Graded Pulmonary Exacerbations | 52 weeks | Randomised and Treated (referred to as the ITT population in this trial) | GPE events per year | NUMBER |
| SECONDARY | Quality of Life as Measured by the St. Georges Respiratory Questionnaire (SGRQ) Total Score | 52 weeks | Randomised and treated with one or more post-baseline SGRQ data available | units on a scale | MEAN |
| SECONDARY | Antibiotic Use Prescribed for Treated Pulmonary Exacerbations | 52 weeks | Randomised and treated (referred to as ITT) | events/year | NUMBER |
| SECONDARY | Time to First Graded Exacerbation | 52 weeks | Randomised and treated | months | MEDIAN |
| SECONDARY | Duration of Graded Exacerbations | 52 weeks | Randomised and treated | Days with GPE | MEAN |
| SECONDARY | Sputum Volume | 52 weeks | g | MEAN | |
| SECONDARY | Daytime Sleepiness Scores | 52 weeks | units on a scale | MEAN | |
| SECONDARY | Lung Function - Change in FEV1 (Forced Expiratory Volume in One Second) | 52 weeks | Randomised and treated with at least one post-baseline spirometry assessment | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Lung Function - Change in FVC (Forced Vital Capacity) | 52 weeks | Randomised and treated with at least one post-baseline spirometry assessment | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Lung Function - Change in FEV1/FVC | 52 weeks | Randomised and treated with at least one post-baseline spirometry assessment | ratio (expressed as a %) | LEAST_SQUARES_MEAN |
| SECONDARY | Lung Function - Change in FEF25-75 (Forced Expiratory Flow Rate Averaged Over 25th -75th Percentile of FVC) | 52 weeks | Randomised and treated with at least one post-baseline spirometry assessment | mL/s | LEAST_SQUARES_MEAN |
| SECONDARY | Safety Profile - Sputum Microbiology | 52 weeks | participants | NUMBER | |
| SECONDARY | Safety Profile - Clinical Chemistry | 52 weeks | participants | NUMBER | |
| SECONDARY | Safety Profile - Hematology | 52 weeks | participants | NUMBER | |
| SECONDARY | • (Exploratory) Number of Hospitalizations Due to Pulmonary Exacerbations | 52 weeks | hospitalisations/year | MEAN | |
| OTHER_PRE_SPECIFIED | Health Related Costs of Treating Patients With Bronchiectasis | 52 weeks | No data were collected. Since the primary objective was not significant in this study, further exploration of health economic endpoints was not done. | ||
| OTHER_PRE_SPECIFIED | Health Status and Utility Scores | 52 weeks | No data were collected. As the primary objective of this study did not reach statistical significance, health status and utility scores were not derived. | ||
| OTHER_PRE_SPECIFIED | Health Related Quality of Life (HRQL) and Quality Adjusted Life Years (QALYs) by Treatment Group Using Utility Scores From the Health Utilities Index Questionnaire | 52 weeks | No data were collected for this assessment. As the primary objective of this study did not reach statistical significance, HRQL and QALYs were not derived. | ||
| OTHER_PRE_SPECIFIED | Cost Effectiveness of Treating Patients With Bronchiectasis With Inhaled Mannitol | 52 weeks | Not collected. As the primary objective of this study did not reach statistical significance, cost effectiveness data were not collected. |
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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GET https://conductscience.org/api/trials/v1/NCT00669331/outcomes