Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis
Public ClinicalTrials.gov record NCT00669331. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
: A Phase III Multicenter, Randomized, Parallel Group, Controlled, Double Blind Study to Investigate the Safety and Efficacy of Inhaled Mannitol Over 12 Months in the Treatment of Bronchiectasis.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
No gold standard therapy exists for clearing mucus from the airways of patients with bronchiectasis. While rhDNase has a proven place in the treatment of cystic fibrosis (CF), it failed to improve Forced expiratory volume in one second (FEV1) in a short-term non-CF bronchiectasis study and has been shown to be detrimental after 6 months therapy in non CF bronchiectasis, moreover it has no proven effect on mucociliary clearance. Hypertonic saline has been shown to have a comparable mode of action to inhaled mannitol, but has yet to be examined as a long term treatment option in bronchiectasis. The purpose of this study is to examine the efficacy and safety of 52 weeks treatment with inhaled mannitol in subjects with non-cystic fibrosis bronchiectasis. Previous studies with inhaled mannitol have demonstrated improvement in mucociliary clearance; mucus rehydration; improvement in quality of life and respiratory symptoms in patients with bronchiectasis and pulmonary function in cystic fibrosis. The results of this current study in combination with a recently completed 3 month study seek to confirm these early findings and to extend the evidence to support its use as a mucoactive therapy in subjects with bronchiectasis. We hypothesize that mannitol will improve the overall health and hygiene of the lung through regular and effective clearing of the mucus load. As a consequence of the reduction in mucus load and inflammatory process, the frequency of bronchiectasis related pulmonary exacerbations and the need for exacerbation related antibiotic treatment should fall. Days in hospital and community health care costs are expected to change in line with improvements in respiratory health. Finally, we plan to demonstrate that inhaled mannitol is safe and well tolerated over a 52 week period. We will test these hypotheses using 400 mg mannitol twice daily (BD) against control.
Study identification
- NCT ID
- NCT00669331
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 485 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2009 (Type not available)
- Primary completion
- Jan 2014 (Actual)
- Completion
- Jan 2014 (Actual)
- Last update posted
- Apr 29, 2016
2009 – 2014
United States locations
- U.S. sites
- 19
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Jewish Medical and Research Center | Denver | Colorado | 80206 | — |
| University of Connecticut Health Center, Pulmonary Division | Farmington | Connecticut | 06030-1321 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Florida Pulmonary Research | Winter Park | Florida | 32789 | — |
| The University of Chicago Hospitals | Chicago | Illinois | 60637 | — |
| Chest Medicine Clinical Services, LLC | Skokie | Illinois | 60076 | — |
| Allergy and Critical Care Medicine Pulmonary Clinical Research Unit | Rochester | Minnesota | 55905 | — |
| Saint Luke's Hospital | Chesterfield | Missouri | 63017 | — |
| Pulmonary and Allergy Associates | Summit | New Jersey | 07901 | — |
| Winthrop University Hospital | Mineola | New York | 11501 | — |
| Research Associates of New York | New York | New York | 10028 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | — |
| The Oregon Clinic, PC/Pulmonary Division | Portland | Oregon | 97220 | — |
| University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| South Carolina Pharmaceutical Research | Spartanburg | South Carolina | 29303 | — |
| Alamo Clinical Research Associates | San Antonio | Texas | 78212 | — |
| Pulmonary Associates of Richmond, Inc | Richmond | Virginia | 23225 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 64 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00669331, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 29, 2016 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00669331 live on ClinicalTrials.gov.