Trial · NCT00669331
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Graded Pulmonary Exacerbations | 52 weeks | A graded pulmonary exacerbation was defined as a worsening in signs and symptoms requiring a change in treatment (Center for Drug Evaluation and Research (CDER), 2007). Grade I was required 3 main signs and symptoms, Grade II 2 main signs and symptoms and Grade III 1 main and one or more minor signs and symptoms. Main signs and symptoms were increased cough, sputum volume or sputum purulence. Minor were upper respiratory tract infection, fever, increased wheezing, increased dyspnea, increase in respiratory rate, increase in cardiac frequency of \>20%, and increased malaise, fatigue or lethargy. Rate is defined as the number of all GPE events observed in one treatment year |
| Secondary | Quality of Life as Measured by the St. Georges Respiratory Questionnaire (SGRQ) Total Score | 52 weeks | The SGRQ was collected at baseline, week 6, week 16, week 28, week 40 and week 52. Change in total score was calculated from baseline. Total scores are a weighted sum across all questions. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. Higher scores indicate lower quality of life. Outcome data table gives the raw mean total score at each visit. |
| Secondary | Antibiotic Use Prescribed for Treated Pulmonary Exacerbations | 52 weeks | Rate of antibiotic treated graded pulmonary exacerbations, using the same definition of a graded pulmonary exacerbation as the primary endpoint. A graded pulmonary exacerbation was considered to be anti-biotic treated if use of oral, IV or inhaled antibiotic use was recorded related to the GPE event. |
| Secondary | Time to First Graded Exacerbation | 52 weeks | Time to first graded exacerbation is defined as the duration (in months) from the randomisation date to the start of the first reported graded PE during the on-treatment period. Patients without reported graded PE event will be censored at the last participation. |
| Secondary | Duration of Graded Exacerbations | 52 weeks | Duration of graded exacerbations is defined as the number of days with graded PE within one treatment year. Mean days estimated via negative binomial model with treatment, region and baseline pulmonary exacerbation rate as predictors, with log of follow-up time as the offset variable |
| Secondary | Sputum Volume | 52 weeks | 24 hour sputum weight, measured at baseline, week 6, week 16, week 28, week 40, week 52 |
| Secondary | Daytime Sleepiness Scores | 52 weeks | Epworth Sleepiness Scale (ESS) score was calculated as the sum of scores for each of eight individual questions, such that a total score of zero represents no daytime sleepiness, and a total score of 24 represents the maximum degree of daytime sleepiness. Measured at baseline, 6 weeks, 16 weeks, 28 weeks, 40 weeks, 52 weeks |
| Secondary | Lung Function - Change in FEV1 (Forced Expiratory Volume in One Second) | 52 weeks | |
| Secondary | Lung Function - Change in FVC (Forced Vital Capacity) | 52 weeks | |
| Secondary | Lung Function - Change in FEV1/FVC | 52 weeks | FEV1 expressed as a ratio of FVC. Endpoint is expressed as a percentage ie FEV1/FVC\*100 |
| Secondary | Lung Function - Change in FEF25-75 (Forced Expiratory Flow Rate Averaged Over 25th -75th Percentile of FVC) | 52 weeks | |
| Secondary | Safety Profile - Sputum Microbiology | 52 weeks | sputum microbiology assessed as the presence of abnormal flora in sputum sample taken at any post baseline visit |
| Secondary | Safety Profile - Clinical Chemistry | 52 weeks | Clinical chemistry was assessed as clinically significant abnormal liver function test and clinically significant abnormal urea/electrolyte test at any point post baseline. |
| Secondary | Safety Profile - Hematology | 52 weeks | hematology assessed as clinically significant abnormal FBC (Full Blood count) at any point post baseline. |
| Secondary | • (Exploratory) Number of Hospitalizations Due to Pulmonary Exacerbations | 52 weeks | Mean rate of hospitalisations (number/year) summarised and analysed to take account of differing follow-up times. |
| Other | Health Related Costs of Treating Patients With Bronchiectasis | 52 weeks | In the presence of a significant primary endpoint, these data were intended to be derived using the trial data together with external information (Note as the primary objective of this study did not reach statistical significance, health related costs were not assessed) |
| Other | Health Status and Utility Scores | 52 weeks | In the presence of a significant primary endpoint, these data were intended to be derived from the trial data and external information (Note as the primary objective of this study did not reach statistical significance, differences in health status and utility scores were not assessed) |
| Other | 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 | In the presence of a significant primary endpoint, these data were intended to be derived using the trial data and external information (Note as the primary objective of this study did not reach statistical significance, HRQL and QALYs were not collected). |
| Other | Cost Effectiveness of Treating Patients With Bronchiectasis With Inhaled Mannitol | 52 weeks | In the presence of a significant primary endpoint, these data were intended to be derived using the trial data and external information (Note as the primary objective of this study did not reach statistical significance, cost effectiveness was 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/registered