Trial · NCT00630812
Long Term Administration of Inhaled Mannitol in Cystic Fibrosis
NCT00630812, Phase 3, Completed, Syntara; results first posted 2020-10-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long Term Administration of Inhaled Mannitol in Cystic Fibrosis. Trials, record NCT00630812. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00630812
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long Term Administration of Inhaled Mannitol in Cystic Fibrosis
- NCT number
- NCT00630812
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 318 participants, actual
- Lead sponsor
- Syntara
- Conditions
- Cystic Fibrosis
- Interventions
- inhaled mannitol, Placebo comparator
- First posted
- 2008-03-07
- Last updated
- 2020-10-09
- Results first posted
- 2020-10-09
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Absolute FEV1 From Baseline Over 26 Weeks | 26 weeks | Change from baseline in forced expiratory volume at one second (FEV1) averaged over 26 weeks (measured at 6,14 and 26 weeks) The mean absolute change from baseline FEV1 (mL) over 26 weeks (measured at week 6, 14 and 26) will be compared between the two treatment groups with a REML (restricted maximum likelihood) based repeated measures approach.Least square means presented are for the average change over the 6, 14, and 26 week visits. |
| Secondary | Change in FEV1 From Baseline Over 26 Weeks - Dornase Users | 26 weeks | In the subset of dornase users, the mean absolute change from baseline FEV1 (mL) averaged over 26 weeks (measured at week 6, 14 and 26) will be compared between the two treatment groups with a REML (restricted maximum likelihood) based repeated measures approach. Least square means presented are for the average change over the 6, 14, and 26 week visits. Change from baseline over 26 weeks (measured at 6,14, 26 weeks) in subset of dornase users |
| Secondary | Rate of Protocol Defined Pulmonary Exacerbations (PDPE) | 26 weeks | Exacerbations treated with IV antibiotics and with at least 4 signs and symptoms according to Fuchs criteria (1994). Summary table presents the number with 0, 1,2 and 3 PDPEs during the 26 week treatment period. |
| Secondary | Hospitalisations Associated With Protocol Defined Pulmonary Exacerbations (PDPEs) | 26 weeks | The number of hospitalisations is summarised and then the rate per person is analysed. |
| Secondary | Antibiotic Use Associated With PDPEs | 26 weeks | Number of courses per person in the 26 week period is summarised and then the rate per person analysed. |
| Secondary | Absolute Change in FEV1 Percent Predicted at 26 Weeks | 26 weeks | Change from baseline at 26 weeks in FEV1 percent predicted with BOCF for those with missing values at week 26 |
| Secondary | Change in FVC (mL) Across 26 Weeks | 26 weeks | Change from baseline in forced vital capacity (FVC) across 26 weeks (measured at 6,14 and 26 weeks) |
| Secondary | Change From Baseline FEF25-75 (mL/s) Over 26 Weeks | 26 weeks | Change from baseline in forced expiratory flow at 25-75% of forced vital capacity (FEF25-75) (mL/s) averaged over 26 weeks (measured at 6,14 and 26 weeks) The mean absolute change from baseline over 26 weeks (measured at week 6, 14 and 26) was compared between the two treatment groups with a REML (restricted maximum likelihood) based repeated measures approach. Least square means presented are for the average change over the 6, 14, and 26 week visits. |
| Secondary | Sputum Weight at Baseline in Response to First Dose of Treatment | up to 30 mins after first dose of trial treatment | Sputum was collected during and for 30 minutes following the administration of the first dose of study treatment. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Absolute FEV1 From Baseline Over 26 Weeks | 26 weeks | mITT (modified intent to treat) - patients randomised and treated with at least one dose of study medication) | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change in FEV1 From Baseline Over 26 Weeks - Dornase Users | 26 weeks | Note these are subset of dornase users - effect in dornase users was estimated using a model fitted using data from all patients | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Protocol Defined Pulmonary Exacerbations (PDPE) | 26 weeks | mITT (randomised and treated) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hospitalisations Associated With Protocol Defined Pulmonary Exacerbations (PDPEs) | 26 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Antibiotic Use Associated With PDPEs | 26 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Absolute Change in FEV1 Percent Predicted at 26 Weeks | 26 weeks | Baseline Observation carried forward (BOCF) implemented for those with missing values at visit 4 | % of predicted | LEAST_SQUARES_MEAN |
| SECONDARY | Change in FVC (mL) Across 26 Weeks | 26 weeks | mL | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline FEF25-75 (mL/s) Over 26 Weeks | 26 weeks | mL/s | LEAST_SQUARES_MEAN | |
| SECONDARY | Sputum Weight at Baseline in Response to First Dose of Treatment | up to 30 mins after first dose of trial treatment | Patients randomised and treated who have sputum weight results available. | g | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Absolute FEV1 From Baseline Over 26 Weeks | Mannitol 400mg | 106.53 | 95% Confidence Interval 62.43 to 150.62 | mL | |
| Change in Absolute FEV1 From Baseline Over 26 Weeks | Control | 52.38 | 95% Confidence Interval 2.09 to 102.68 | mL | |
| Change in FEV1 From Baseline Over 26 Weeks - Dornase Users | Mannitol 400mg | 78.60 | 95% Confidence Interval 27.64 to 129.56 | mL | |
| Change in FEV1 From Baseline Over 26 Weeks - Dornase Users | Control | 35.11 | 95% Confidence Interval -20.99 to 91.21 | mL | |
| Rate of Protocol Defined Pulmonary Exacerbations (PDPE) | Mannitol 400mg | With 1 PDPE | 21 | Participants | |
| Rate of Protocol Defined Pulmonary Exacerbations (PDPE) | Control | With 1 PDPE | 18 | Participants | |
| Rate of Protocol Defined Pulmonary Exacerbations (PDPE) | Mannitol 400mg | With 2 PDPE | 6 | Participants | |
| Rate of Protocol Defined Pulmonary Exacerbations (PDPE) | Control | With 2 PDPE | 4 | Participants | |
| Rate of Protocol Defined Pulmonary Exacerbations (PDPE) | Mannitol 400mg | With 3 PDPE | 1 | Participants | |
| Rate of Protocol Defined Pulmonary Exacerbations (PDPE) | Control | With 3 PDPE | 1 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 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 400mg | 192 | |
| Randomisation to First Dose | STARTED | Control | 126 | |
| Randomisation to First Dose | COMPLETED | Mannitol 400mg | 184 | |
| Randomisation to First Dose | COMPLETED | Control | 121 | |
| Randomisation to First Dose | NOT COMPLETED | Mannitol 400mg | 8 | |
| Randomisation to First Dose | NOT COMPLETED | Control | 5 | |
| Double Blind Treatment Period | STARTED | Mannitol 400mg | 184 | |
| Double Blind Treatment Period | STARTED | Control | 121 | |
| Double Blind Treatment Period | COMPLETED | Mannitol 400mg | 153 | |
| Double Blind Treatment Period | COMPLETED | Control | 107 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events60
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 | Condition Aggravated | General disorders | Mannitol 400mg | 57 | 184 | |
| other | Condition Aggravated | General disorders | Control | 41 | 121 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Mannitol 400mg | 28 | 184 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Control | 16 | 121 | |
| other | Headache | Nervous system disorders | Mannitol 400mg | 26 | 184 | |
| other | Headache | Nervous system disorders | Control | 22 | 121 | |
| other | Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Mannitol 400mg | 19 | 184 | |
| other | Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Control | 13 | 121 | |
| other | Pyrexia | General disorders | Mannitol 400mg | 17 | 184 | |
| other | Pyrexia | General disorders | Control | 13 | 121 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mannitol 400mg | 0 | 184 |
| Total, all-cause mortality | Control | 1 | 121 |
| Total, other adverse events | Mannitol 400mg | 165 | 184 |
| Total, other adverse events | Control | 106 | 121 |
| Total, serious adverse events | Mannitol 400mg | 31 | 184 |
| Total, serious adverse events | Control | 30 | 121 |
Source ClinicalTrials.gov
Papers11
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mannitol 400mg vs Control: deaths from any cause | Trial comparisons |
| Mannitol 400mg 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/NCT00630812
GET https://conductscience.org/api/trials/v1/NCT00630812/results?page=2