Trial · NCT00669331
Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis
NCT00669331, Phase 3, Completed, Syntara; results first posted 2016-04-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis. Trials, record NCT00669331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00669331
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis
- NCT number
- NCT00669331
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 485 participants, actual
- Lead sponsor
- Syntara
- Conditions
- Bronchiectasis
- Interventions
- Inhaled mannitol, Matched control
- First posted
- 2008-04-30
- Last updated
- 2016-04-29
- Results first posted
- 2016-04-29
- Limitations and caveats
Relatively few studies in this area -ideal choice of endpoints not well-defined. No widely accepted exacerbation definition. Relies on patients' accurate \& timely symptom reporting.Unclear event end-dates may impact on counting of subsequent events.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Graded Pulmonary Exacerbations | Mannitol | Raw rate | 1.95 | GPE events per year | |
| Rate of Graded Pulmonary Exacerbations | Control | Raw rate | 2.10 | GPE events per year | |
| Rate of Graded Pulmonary Exacerbations | Mannitol | Rate from negative binomial model | 1.69 | GPE events per year | |
| Rate of Graded Pulmonary Exacerbations | Control | Rate from negative binomial model | 1.84 | GPE events per year | |
| Quality of Life as Measured by the St. Georges Respiratory Questionnaire (SGRQ) Total Score | Mannitol | Baseline | 52.98 | Standard Deviation 14.64 | units on a scale |
| Quality of Life as Measured by the St. Georges Respiratory Questionnaire (SGRQ) Total Score | Control | Baseline | 52.22 | Standard Deviation 14.71 | units on a scale |
| Quality of Life as Measured by the St. Georges Respiratory Questionnaire (SGRQ) Total Score | Mannitol | Week 6 | 44.09 | Standard Deviation 17.49 | units on a scale |
| Quality of Life as Measured by the St. Georges Respiratory Questionnaire (SGRQ) Total Score | Control | Week 6 | 44.55 | Standard Deviation 18.49 | units on a scale |
| Quality of Life as Measured by the St. Georges Respiratory Questionnaire (SGRQ) Total Score | Mannitol | Week 16 | 40.67 | Standard Deviation 19.07 | units on a scale |
| Quality of Life as Measured by the St. Georges Respiratory Questionnaire (SGRQ) Total Score | Control | Week 16 | 44.23 | Standard Deviation 19.89 | units on a scale |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomisation to First Dose | STARTED | Mannitol | 244 | |
| Randomisation to First Dose | STARTED | Control | 241 | |
| Randomisation to First Dose | COMPLETED | Mannitol | 233 | |
| Randomisation to First Dose | COMPLETED | Control | 228 | |
| Randomisation to First Dose | NOT COMPLETED | Mannitol | 11 | |
| Randomisation to First Dose | NOT COMPLETED | Control | 13 | |
| Blinded Treatment Period | STARTED | Mannitol | 233 | |
| Blinded Treatment Period | STARTED | Control | 228 | |
| Blinded Treatment Period | COMPLETED | Mannitol | 191 | |
| Blinded Treatment Period | COMPLETED | Control | 189 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events126
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Mannitol | 15 | 233 | |
| other | Diarrhoea | Gastrointestinal disorders | Control | 21 | 228 | |
| other | Nausea | Gastrointestinal disorders | Mannitol | 14 | 233 | |
| other | Nausea | Gastrointestinal disorders | Control | 18 | 228 | |
| other | Condition aggravated | General disorders | Mannitol | 149 | 233 | |
| other | Condition aggravated | General disorders | Control | 159 | 228 | |
| other | Lower respiratory tract infection | Infections and infestations | Mannitol | 16 | 233 | |
| other | Lower respiratory tract infection | Infections and infestations | Control | 21 | 228 | |
| other | Lower respiratory tract infection bacterial | Infections and infestations | Mannitol | 12 | 233 | |
| other | Lower respiratory tract infection bacterial | Infections and infestations | Control | 9 | 228 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mannitol | ||
| Total, all-cause mortality | Control | ||
| Total, other adverse events | Mannitol | 215 | 233 |
| Total, other adverse events | Control | 214 | 228 |
| Total, serious adverse events | Mannitol | 43 | 233 |
| Total, serious adverse events | Control | 51 | 228 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mannitol vs Control: Safety Profile - Sputum Microbiology | Trial comparisons |
| Mannitol vs Control: Safety Profile - Hematology | Trial comparisons |
| Mannitol vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00669331
GET https://conductscience.org/api/trials/v1/NCT00669331/results?page=2