Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis
NCT ID: NCT00669331
Last Updated: 2016-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
485 participants
INTERVENTIONAL
2009-11-30
2014-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Mannitol
Inhaled mannitol 400mg
Inhaled mannitol
400mg dose of Mannitol BD (twice a day) for 52 weeks
Control
Matched control - inhaled mannitol 50mg
Matched control
50mg dose of Mannitol BD (twice a day) for 52 weeks
Interventions
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Inhaled mannitol
400mg dose of Mannitol BD (twice a day) for 52 weeks
Matched control
50mg dose of Mannitol BD (twice a day) for 52 weeks
Eligibility Criteria
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Inclusion Criteria
2. Have documented evidence of confirmed diagnosis of (non-cystic fibrosis) bronchiectasis by computed tomography (CT), High resolution computed tomography (HRCT) or bronchogram
3. Be aged 18 - 85 years inclusive, male and female
4. Have FEV1 (Forced expiratory volume in one second) ≥ 40% and ≤85% predicted\* and ≥1.0L (\*according to NHANES III predicted tables) measured at Visit 0A (V0A)
5. Clinician documented history of at least 2 pulmonary exacerbations, each requiring antibiotic therapy, in the last 12 months prior to Visit 0A (V0A) and a total of at least 4 in the last 2 years prior to Visit 0A
6. Have a total SGRQ (St George's respiratory questionnaire) score of ≥30 at Visit 0B (V0B)
7. Have a production of ≥10g of sputum at Visit 0B Have reported chronic sputum production of ≥1 tablespoon (15mL) per day on the majority of days in the 3 months prior to Visit 0A
8. Be able to perform all the techniques necessary to measure lung function
9. Have FEV1 ≥40% predicted\* and ≥1.0L (\*according to NHANES III 1999 predicted tables) measured at V0B (Baseline result prior to MTT (Mannitol Tolerance Test) administration)
Exclusion Criteria
2. Have bronchiectasis as a consequence of cystic fibrosis or focal endobronchial lesion or otherwise curable causes (e.g. foreign body aspiration)
3. Be considered "terminally ill" or listed for transplantation
4. Be using hypertonic saline in the 14 days prior to commencing Visit 0B or thereafter at any time during the study
5. Have previously used inhaled mannitol (Bronchitol) for more than a day
6. Have had a significant episode of hemoptysis (\>60 mL) in the previous 6 months
7. Have had rescue antibiotics in the 4 weeks prior to V0B (chronic background antibiotic therapy accepted)
8. Have smoked within the last 3 months and must not smoke during their participation in the study
9. Have had a myocardial infarction in the three months prior to Visit 0A
10. Have had a cerebral vascular accident in the three months prior to Visit 0A
11. Have had major ocular surgery in the three months prior to Visit 0A
12. Have had major abdominal, chest or brain surgery in the three months prior to Visit 0A
13. Have a known cerebral, aortic or abdominal aneurysm
14. Have actively treated Mycobacterium tuberculosis
15. Have actively treated or unstable nontuberculous mycobacterial (NTM)infection or be under consideration for NTM treatment in the next 12 months
16. Have unstable Allergic bronchopulmonary aspergillosis (ABPA) requiring steroid therapy (≤5mg dose oral steroids in stable ABPA accepted)
17. Have end stage interstitial lung disease
18. Have active malignancy including melanoma (other skin carcinomas exempted). Remissions from any malignancy ≥2 years also exempted
19. Be breast feeding or pregnant, or plan to become pregnant while in the study
20. Be using an unreliable form of contraception (female subjects at risk of pregnancy only)
21. Be participating in another investigational drug study, parallel to, or within 4 weeks of Visit 0A
22. Have a known intolerance to mannitol or β2-agonists
23. Have uncontrolled hypertension - e.g. for adults: systolic blood pressure (BP) \> 190 and or diastolic BP \> 100
24. Subject has a condition or is in a situation which in the Investigator's opinion may put the subject at significant risk, may confound results or may interfere significantly with the patient's participation in the study
25. Have previously been screen failed for the study (exceptions - see section 3.3.2 Eligibility Criteria - Rescreening)
18 Years
85 Years
ALL
No
Sponsors
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Syntara
INDUSTRY
Responsible Party
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Principal Investigators
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Diana Bilton, MD
Role: PRINCIPAL_INVESTIGATOR
Brompton Hospital London UK
Greg Tino, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania Medical Centre, Philadelphia
Alan Barker, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health Sciences University, Portland Oregon
Locations
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National Jewish Medical and Research Center
Denver, Colorado, United States
University of Connecticut Health Center, Pulmonary Division
Farmington, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
Florida Pulmonary Research
Winter Park, Florida, United States
The University of Chicago Hospitals
Chicago, Illinois, United States
Chest Medicine Clinical Services, LLC
Skokie, Illinois, United States
Allergy and Critical Care Medicine Pulmonary Clinical Research Unit
Rochester, Minnesota, United States
Saint Luke's Hospital
Chesterfield, Missouri, United States
Pulmonary and Allergy Associates
Summit, New Jersey, United States
Winthrop University Hospital
Mineola, New York, United States
Research Associates of New York
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
The Oregon Clinic, PC/Pulmonary Division
Portland, Oregon, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
South Carolina Pharmaceutical Research
Spartanburg, South Carolina, United States
Alamo Clinical Research Associates
San Antonio, Texas, United States
Pulmonary Associates of Richmond, Inc
Richmond, Virginia, United States
Hospital Zonal Especializado en Agudos y Cronicos "Dr Antonio A. Cetrangolo
Florida Partido de Vicente López, Buenos Aires, Argentina
Centro Respiratorio Quilmes
Quilmes, Buenos Aires, Argentina
Instituto Argentino de Investigación Neurológica
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Privado - Centro Medico de Cordoba
Córdoba, Córdoba Province, Argentina
Insares
Mendoza, Mendoza Province, Argentina
Centro Privado de Medicina Respiratoria
Entre Ríos, Paraná Entre Ríos, Argentina
Hospital Interzonal General de Agudos "Dr Jose Penna"
Bahia Bianca, Provinica de Buenos Aires, Argentina
Corporacion medica de General San Martin
Matheu, San Martin Provincia de Buenos Aires, Argentina
Clinica del Torax
Rosario, Santa Fe Province, Argentina
Instituto Cardiovascular de Rosario
Rosario, Santa Fe Province, Argentina
Sanatorio Parque
Rosario, Santa Fe Province, Argentina
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, Tucumán Province, Argentina
Centro Médico Dra. De Salvo
Buenos Aires, , Argentina
Atención Integral en Reumatología (AIR)
Buenos Aires, , Argentina
Woolcock Institute of Medical Research
Glebe, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Repatriation General Hospital
Daws Park, South Australia, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
St Vincent's Hospital
Fitzroy, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
The Rooms of Dr C Steinfort
Geelong, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
ULB Hopital Erasme - Department of Pneumology
Brussels, Brussels Capital, Belgium
Cliniques Universitaires St. Luc (UCL) - Department of Pulmonology
Brussels, Brussels Capital, Belgium
UZ Leuven (University Hospital Leuven) - Depatment of Pulmonary Medicine
Leuven, Leuven, Belgium
Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, Chile
Universidad de Chile
Santiago, Santiago Metropolitan, Chile
Hospital Regional de Talca
Talca, Talca, Chile
IKF Pneumologie GmbH and Co KG
Frankfurt am Main, Hesse, Germany
Medizinische Hochschule Hannover Klinik für Pneumologie
Hanover, Lower Saxony, Germany
Lungen und Bronchialheikunde
Bonn, North Rhine-Westphalia, Germany
Pneumologisch Studienzentrum
Leipzig, Saxony, Germany
Medisch Centrum Alkmaar - Department of Pulmonary Medicine
Alkmaar, Alkmaar AM, Netherlands
Atrium MC -Department of Pulmonary Diseases
Heerlen, Heerlen, Netherlands
Medisch Centrum Leeuwarden (MCL) - Department of Pulmonology
Leeuwarden, Leeuwarden AD, Netherlands
Middlemore Hospital
Auckland, Auckland, New Zealand
Green Lane Clinical Centre
Greenlane, Auckland, New Zealand
Waikato Hospital
Hamilton, , New Zealand
West Wales General Hospital
Carmarthen, Carmarthenshire, United Kingdom
Royal Derby Hospital
Derby, Derbyshire, United Kingdom
Royal Devon and Exeter Hospital
Exeter, Devon, United Kingdom
Torbay Hospital
Torquay, Devon, United Kingdom
Castle Hill Hospital
Cottingham, East Yorkshire, United Kingdom
Glenfield Hospital
Leicester, Leicestershire, United Kingdom
Nottingham City Hospital
Nottingham, Nottinghamshire, United Kingdom
Churchill Hospital
Headington, Oxfordshire, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, Shropshire, United Kingdom
Sheffield Northern General Hospital
Sheffield, South Yorkshire, United Kingdom
Stafford Hospital
Stafford, Staffordshire, United Kingdom
Ashford & St Peters Hospital
Chertsey, Surrey, United Kingdom
University Hospital of North Tees
Stockton, Teeside, United Kingdom
Llandough Hospital
Cardiff, Vale of Glamorgan, United Kingdom
Birmingam Queen Elizabeth Hospital
Birmingham, West Midlands, United Kingdom
Wolverhampton New Cross Hospital
Wolverhampton, West Midlands, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Belfast City Hospital
Belfast, , United Kingdom
University Hospital Aintree
Liverpool, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
North Tyneside General Hospital
North Shields, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Wrexham Maelor Hospital
Wrexham, , United Kingdom
Countries
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References
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Daviskas E, Anderson SD, Eberl S, Chan HK, Bautovich G. Inhalation of dry powder mannitol improves clearance of mucus in patients with bronchiectasis. Am J Respir Crit Care Med. 1999 Jun;159(6):1843-8. doi: 10.1164/ajrccm.159.6.9809074.
Daviskas E, Anderson SD, Eberl S, Young IH. Effect of increasing doses of mannitol on mucus clearance in patients with bronchiectasis. Eur Respir J. 2008 Apr;31(4):765-72. doi: 10.1183/09031936.00119707. Epub 2007 Dec 5.
Daviskas E, Anderson SD, Young IH. Inhaled mannitol changes the sputum properties in asthmatics with mucus hypersecretion. Respirology. 2007 Sep;12(5):683-91. doi: 10.1111/j.1440-1843.2007.01107.x.
Daviskas E, Anderson SD. Hyperosmolar agents and clearance of mucus in the diseased airway. J Aerosol Med. 2006 Spring;19(1):100-9. doi: 10.1089/jam.2006.19.100.
Daviskas E, Anderson SD, Gomes K, Briffa P, Cochrane B, Chan HK, Young IH, Rubin BK. Inhaled mannitol for the treatment of mucociliary dysfunction in patients with bronchiectasis: effect on lung function, health status and sputum. Respirology. 2005 Jan;10(1):46-56. doi: 10.1111/j.1440-1843.2005.00659.x.
Daviskas E, Robinson M, Anderson SD, Bye PT. Osmotic stimuli increase clearance of mucus in patients with mucociliary dysfunction. J Aerosol Med. 2002 Fall;15(3):331-41. doi: 10.1089/089426802760292681.
Daviskas E, Anderson SD, Eberl S, Chan HK, Young IH. The 24-h effect of mannitol on the clearance of mucus in patients with bronchiectasis. Chest. 2001 Feb;119(2):414-21. doi: 10.1378/chest.119.2.414.
Bilton D, Tino G, Barker AF, Chambers DC, De Soyza A, Dupont LJ, O'Dochartaigh C, van Haren EH, Vidal LO, Welte T, Fox HG, Wu J, Charlton B; B-305 Study Investigators. Inhaled mannitol for non-cystic fibrosis bronchiectasis: a randomised, controlled trial. Thorax. 2014 Dec;69(12):1073-9. doi: 10.1136/thoraxjnl-2014-205587. Epub 2014 Sep 21.
Other Identifiers
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DPM-B-305
Identifier Type: -
Identifier Source: org_study_id
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