Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis

Condition(s) targeted: Bronchiectasis

Intervention: Inhaled mannitol (Drug); matched control (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pharmaxis

Official(s) and/or principal investigator(s):
Diana Bilton, MD, Principal Investigator, Affiliation: Brompton Hospital London UK
Greg Tino, MD, Principal Investigator, Affiliation: University of Pennsylvania Medical Centre, Philadelphia
Alan Barker, MD, Principal Investigator, Affiliation: Oregon Health Sciences University, Portland Oregon

Overall contact:
Brett Charlton, MBBS, Phone: 61 2 94547200

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 CF, it failed to improve 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 against control.

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: • To show a significant difference in the rates of graded pulmonary exacerbations, in patients with bronchiectasis treated with inhaled mannitol compared to placebo control

Secondary outcome:

To show a significant difference in Quality of Life as measured by the St. Georges Respiratory Questionnaire (SGRQ) in patients with bronchiectasis treated with inhaled mannitol compared to placebo control

• To show a significant difference in antibiotic use prescribed for treated pulmonary exacerbations in patients with bronchiectasis treated with inhaled mannitol compared to placebo control.

• To show a significant improvement in other graded exacerbation parameters (time to first exacerbation and duration of exacerbation) in patients with bronchiectasis treated with inhaled mannitol compared to placebo control

• To show a significant difference in sputum volume in patients with bronchiectasis treated with inhaled mannitol compared to placebo control

• To show a significant difference in daytime sleepiness scores in patients with bronchiectasis treated with inhaled mannitol compared to placebo control

• To show a significant difference in lung function (FEV1, FVC, FEV1/FVC, FEF25-75 values) in patients with bronchiectasis treated with inhaled mannitol compared to placebo control

• To monitor the safety profile of inhaled mannitol compared to placebo control in subjects with bronchiectasis by investigating adverse events, airway reactivity, hematology, clinical chemistry, sputum microbiology and vital signs

To compare health related costs of treating patients with bronchiectasis with inhaled mannitol and placebo control

To compare health status and utility scores in patients treated with inhaled mannitol compared to placebo control

To investigate health related quality of life (HRQL) and quality adjusted life years (QALYs) by treatment group using utility scores from the Health Utilities Index Questionnaire

To investigate cost effectiveness of treating patients with bronchiectasis with inhaled mannitol

• (Exploratory) To investigate number of hospitalizations due to pulmonary exacerbations in patients with bronchiectasis treated with inhaled mannitol compared to placebo control

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria

1. Have given written informed consent to participate in this study in accordance with local regulations

2. Have documented evidence of confirmed diagnosis of (non-cystic fibrosis) bronchiectasis by CT, HRCT or bronchogram

3. Be aged 18 - 85 years inclusive, male and female

4. Have FEV1 ≥ 40% and ≤85% predicted* and ≥1. 0L (*according to NHANES III predicted tables)measured at V0A

5. Clinician documented history of at least 2 pulmonary exacerbations, each requiring antibiotic therapy, in the last 12 months prior to Visit 0A and a total of at least 4 in the last 2 years prior to Visit 0A

6. Have a total SGRQ score of ≥30 at Visit 0B

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 administration)

Exclusion Criteria

1. Be investigators, site personnel directly affiliated with this study, or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.

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 infection or be under consideration for NTM treatment in the next 12 months

16. Have unstable 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 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)

Brett Charlton, MBBS, Phone: 61 2 94547200

Atención Integral en Reumatología (AIR), Buenos Aires CP1426, Argentina; Recruiting
Vera Duek, MD, Phone: +54 11 4781 2499, Email: reumair@yahoo.com.ar
Maria Eugenia Alais, Principal Investigator

Centro Médico Dra. De Salvo, Ciudad Autonoma de Buenos Aires CP1426ABO, Argentina; Recruiting
Claudia Daniela Archer, Phone: +54 11 4781 5331, Email: cda1023@yahoo.com.ar
Maria Christina De Salvo, Principal Investigator

Cliniques Universitaires St. Luc (UCL) - Department of Pulmonology, Brussels B-1200, Belgium; Recruiting

ULB Hopital Erasme - Department of Pneumology, Brussels B-1070, Belgium; Recruiting

UZ Leuven (University Hospital Leuven) - Depatment of Pulmonary Medicine, Leuven B-3000, Belgium; Recruiting

Atrium MC -Department of Pulmonary Diseases, Heerlen 6419, Netherlands; Recruiting
Sjef Smeets, Phone: +31 45 576 6027
Dr van Haren, Principal Investigator

Middlemore Hospital, Auckland 1640, New Zealand; Recruiting
Gene Jeon, Phone: +64 (9) 276 0044, Ext: 2170, Email: chae-in.jeon@ccrep.org.nz
Conor O'Dochartaigh, Principal Investigator

Waikato Hospital, Hamilton 3240, New Zealand; Recruiting
Christine Tuffery, Phone: 64 7 839 8899, Ext: 8070, Email: Christine.Tuffery@waikatodhb.health.nz
Janice Wong, Principal Investigator

Aberdeen Royal Infirmary, Aberdeen AB25 22N, United Kingdom; Recruiting
Sandra Steele, Phone: 01224 551218, Email: sandra.steele@nhs.net
Graham Douglas, Principal Investigator

Belfast City Hospital, Belfast BT9 7AB, United Kingdom; Recruiting
Lisa Kent, Phone: 02890263064, Email: Lisa.kent@belfasttrust.hscni.net
Stuart Elborn, Principal Investigator

University Hospital Aintree, Liverpool L9 7AL, United Kingdom; Recruiting
Pam Parry, Phone: 0151 529 2783, Email: pam.parry@aintree.nhs.uk
Paul Walker, Principal Investigator

Royal Brompton Hospital, London SW3 6NP, United Kingdom; Recruiting
Sandra Scott, MD, Phone: 020 7351 8121, Ext: 4068, Email: sandra.scott@imperial.ac.uk
Diana Bilton, Principal Investigator

Freeman Hospital, Newcastle-upon-Tyne NE7 7DN, United Kingdom; Recruiting
Therese Small, Phone: 0191 223 1148, Email: therese.small@nuth.nhs.uk
Anthony De Soyza, Principal Investigator

North Tyneside General Hospital, North Shields NE29 8NH, United Kingdom; Recruiting
Jane Dickson, Phone: 01912934559, Email: jane.dickson@nhct.nhs.uk
Stephen Bourke, Principal Investigator

Southampton General Hospital, Southampton SO16 6YD, United Kingdom; Recruiting
Sarah Payne, Phone: 02380 796 759 / 777 222, Email: sarah.payne@suht.swest.nhs.uk
Mary Carroll, Principal Investigator

Wrexham Maelor Hospital, Wrexham LL13 7TD, United Kingdom; Recruiting
Pam Lloyd, Phone: 0197 872 5514, Email: PAM.LLOYD@wales.nhs.uk
Stephen Kelly, Principal Investigator

Medisch Centrum Alkmaar - Department of Pulmonary Medicine, Alkmaar, Alkmaar AM 1800, Netherlands; Recruiting

Green Lane Clinical Centre, Greenlane, Auckland 1051, New Zealand; Recruiting
Wendy Fergusson, Phone: +64 9 307 4949, Ext: 26241, Email: wfergusson@adhb.govt.nz
John Kolbe, Principal Investigator

Hospital Britannico de Buenos Aires, Perdriel 74, Buenos Aires C1280AEB, Argentina; Recruiting
Gladis Quintero, MD, Phone: +54 11 4304 1081, Ext: 1249, Email: gladisquin38@hotmail.com
Felipe Julio Chertcoff, Principal Investigator

West Wales General Hospital, Carmarthen, Carmarthenshire SA31 2AF, United Kingdom; Recruiting
Annette Williams, Phone: 01267227391, Email: annette.williams@carmarthen.wales.nhs.uk
Carol Llewellyn-Jones, Principal Investigator

Instituto Argentino de Investigación Neurológica, Ciudad Autónoma de Buenos Aires, Ciudad Autónoma de Buenos Aires, C1015ABR, Argentina; Recruiting
Sofia Estrada, Phone: +54 11 4816 3812, Ext: 3612, Email: sofiaestrada@iadin.com.ar
Facundo Nogueira, Principal Investigator

University of Connecticut Health Center, Pulmonary Division, Farmington, Connecticut 06030-1321, United States; Recruiting
Ruth Howard, Phone: 860-679-4903, Email: howard@nso.uchc.edu
Mark Metersky, Principal Investigator

Royal Derby Hospital, Derby, Derbyshire DE22 3NE, United Kingdom; Recruiting
Paula Welch, Phone: 01332 789663, Email: paula.welch@nhs.net
Irfan Wahedna, Principal Investigator

Royal Devon and Exeter Hospital, Exeter, Devon EX2 5DW, United Kingdom; Recruiting
Alison Potter, Phone: 01392 406965, Email: alison.potter@rdeft.nhs.uk
Chris Sheldon, Principal Investigator

Torbay Hospital, Torquay, Devon TQ2 7AA, United Kingdom; Recruiting
Lisa Felmeden, Phone: 01803 654499, Email: lisa.felmeden@nhs.net
Lee Dobson, Principal Investigator

Georgetown University Medical Center, Washington, District of Columbia 20007, United States; Recruiting
Michele Cooney, Phone: 202-444-4982, Email: cooneym@gunet.georgetown.edu
Anne O'Donnell, Principal Investigator

Castle Hill Hospital, Cottingham, East Yorkshire HU16 5JQ, United Kingdom; Recruiting
Caroline Wright, Phone: 01482 624009, Email: c.e.wright@hull.ac.uk
Jaymin Morjaria, Principal Investigator

University of Miami, Miami, Florida 33136, United States; Recruiting
Eliana Mendes, Phone: 305-243-2568, Email: emendes@med.miami.edu
Matthias Salathe, Principal Investigator

Florida Pulmonary Research, Winter Park, Florida 32789, United States; Recruiting
Alison Only, Phone: 407-740-8078, Email: only@fpcresearch.com
Faisal Fakih, Principal Investigator

The University of Chicago Hospitals, Chicago, Illinois 60637, United States; Recruiting
Spring Maleckar, Phone: 773-834-4503, Email: smalecka@medicine.bsd.uchicago.edu
Mary Strek, Principal Investigator

Chest Medicine Clinical Services, LLC, Skokie, Illinois 60076, United States; Recruiting
Laurelle Gasich, Phone: 847-679-8475, Email: lgasich@chestmd.com
Vadim Leyenson, Principal Investigator

Medisch Centrum Leeuwarden (MCL) - Department of Pulmonology, Leeuwarden, Leeuwarden AD 8934, Netherlands; Recruiting

Glenfield Hospital, Leicester, Leicestershire LE3 9QP, United Kingdom; Recruiting
Nicola Goodman, Phone: 01162563067, Email: nicola.goodman@uhl-tr.nhs.uk
Simon Range, Principal Investigator

Allergy and Critical Care Medicine Pulmonary Clinical Research Unit, Rochester, Minnesota 55905, United States; Recruiting
Kathy Mieras, MD, Phone: 507-284-9187, Email: mieras.kathleen@mayo.edu
Timothy Aksamit, Principal Investigator

Saint Luke's Hospital, Chesterfield, Missouri 63017, United States; Recruiting
Anna Shipp, Phone: 314-576-4501, Email: anna.shipp@stlukes-stl.com
Neil Ettinger, Principal Investigator

Pulmonary and Allergy Associates, Summit, New Jersey 07901, United States; Recruiting
Marissa Rienton-Lim, Phone: 908-934-0440, Email: marissar@paamds.com
Robert Sussman, Principal Investigator

Woolcock Institute of Medical Research, Glebe, New South Wales 2037, Australia; Recruiting
Julia Chapman, Phone: +61 (0) 2 9114 0449
Greg King, Principal Investigator

St George Hospital, Kogarah, New South Wales 2217, Australia; Recruiting
Linda O'Malley, Phone: +61 (02) 9113 2325, Email: linda.o'malley@sesahs.nsw.gov.au
Steven Lindstrom, Principal Investigator

Winthrop University Hospital, Mineola, New York 11501, United States; Recruiting
Betsy Pinnick, Phone: 516-663-9582, Email: bpinnick@winthrop.org
Jonathan Ilowite, Principal Investigator

Research Associates of New York, New York, New York 10028, United States; Recruiting
Nicole St Vrestil, Phone: 212-996-1105, Email: nicole.stvrestil@nyga.md
Louis DePalo, Principal Investigator

Medizinische Hochschule Hannover Klinik für Pneumologie, Hannover, Niedersachsen 30625, Germany; Recruiting
Rabea Gatzke, Phone: +49 05115323530, Email: pneumologie@mh-hannover.de
Tobias Welte, Principal Investigator

Lungen und Bronchialheikunde, Bonn, Nordrhein-Westfalen 53123, Germany; Recruiting
Gabriele Wieland, Phone: +490228627367, Email: g.wieland@pneumologie-bonn-duisdorf.de
Axel Overlack, Principal Investigator

University of North Carolina, Chapel Hill, North Carolina 27514, United States; Recruiting
Sharikia Burt, Phone: 919-843-2698, Email: sharikia_burt@med.unc.edu
Peadar Noone, Principal Investigator

Nottingham City Hospital, Nottingham, Nottinghamshire NG5 1PB, United Kingdom; Recruiting
Sonia Greenwood, Phone: 0115 9691169, Ext: 54030, Email: sonia.greenwood@nuh.nhs.uk
Wei Shen Lim, Principal Investigator

The Oregon Clinic, PC/Pulmonary Division, Portland, Oregon 97220, United States; Recruiting
Kim Lamorticella, Phone: 503-963-3183, Email: klamorticella@orclinic.com
Melvin Morganroth, Principal Investigator

Centro Privado de Medicina Respiratoria, Entre Rios, Paraná Entre Ríos E3100BHK, Argentina; Recruiting
Santiago Larrateguy, Phone: +54 343 422 8231, Email: ssanti.92@hotmail.com
Luis Larrateguy, Principal Investigator

Temple University Hospital, Philadelphia, Pennsylvania 19140, United States; Recruiting
Sylvia Johnson, Phone: 215-707-4679, Email: sylvia.johnson@tuhs.temple.edu
Gerard Criner, Principal Investigator

University of Pennsylvania Medical Center, Philadelphia, Pennsylvania 19104, United States; Recruiting
Lisa Pauman, Phone: 215-615-0276, Email: lisa.paumen@uphs.upenn.edu
Greg Tino, Principal Investigator

Hospital Zonal Especializado en Agudos y Cronicos "Dr Antonio A. Cetrangolo, Florida Partido de Vicente López, Provincia de Buenos Aires B1602DOH, Argentina; Recruiting
Roxana Noemi Guida, Phone: +54 11 4797 8412, Ext: 115, Email: rguida@fibertel.com.ar
Luis Ángel Otero Vidal, Principal Investigator

Centro Respiratorio Quilmes, Quilmes, Provincia de Buenos Aires B1878FNR, Argentina; Recruiting
Cintia Amato, Phone: +54 11 4224 0046, Email: Cintia_amato@yahoo.com.ar
Marcelo José Fernandez, Principal Investigator

Hospital Privado - Centro Medico de Cordoba, Cordoba, Provincia de Cordoba X5016KEH, Argentina; Recruiting
Ariel Blua, Phone: +54 351 468 8238, Email: arielblua@yahoo.com.ar
Ana Lopez, Principal Investigator

Insares, Mendoza, Provincia de Mendoza M5500CCG, Argentina; Recruiting
Maria Delia Sagua, Phone: +54 261 0628, Email: mdsagua@yahoo.com
Carlos Elias, Principal Investigator

Instituto Cardiovascular de Rosario, Rosario, Provincia de Santa Fe S2000DSR, Argentina; Recruiting
Sandra Anahi Vazquez, Phone: +54 341 420 3063, Email: sandraanahi2001@yahoo.com.ar
Ana Diez, Principal Investigator

Clinica del Torax, Rosario, Provincia de Santa Fe S2000DBS, Argentina; Recruiting
Maria Soledad Crisci, Phone: +54 9 341 447 6777, Email: mariasoledadcrisci@hotmail.com
Carlos Salvarezza, Principal Investigator

Sanatorio Parque, Rosario, Provincia de Santa Fe S2000KZD, Argentina; Recruiting
Silvina Mannarino, Phone: +54 341 420 0222, Ext: 341, Email: smannarino@intramed.net.ar
Fernando de la Riestra, Principal Investigator

Investigaciones en Patologias Respiratorias, San Miguel de Tucumán, Provincia de Tucumán T4000IAR, Argentina; Recruiting
Mariano Lebron, Phone: +54 381 15 233 332, Email: mariano_lebron@hotmail.com
Ramón Ángel Rojas, Principal Investigator

Hospital Interzonal General de Agudos "Dr Jose Penna", Bahia Bianca, Provinica de Buenos Aires B8001DDU, Argentina; Recruiting
María Poli, Phone: +54 291 459 3676, Email: u_poli_71@hotmail.com
Pablo Acrogliano, Principal Investigator

The Prince Charles Hospital, Chermside, Queensland 4032, Australia; Recruiting
Debra Enever, Phone: +619(0) 7 3139 5122, Email: Debra_Enever@health.qld.gov.au
Daniel Chambers, Principal Investigator

Pneumologisch Studienzentrum, Leipzig, Sachsen 4357, Germany; Recruiting
Maria Wartmann, Email: pois_gessner@web.de
Christian Gessner, Principal Investigator

Corporacion medica de General San Martin, Mathew 4071, San Martin Provincia de Buenos Aires B1650CSQ, Argentina; Recruiting
Antonia Rodriguez, MD, Phone: +54 11 4754 7500, Ext: 699
Julio Daniel Antuni, Principal Investigator

Royal Shrewsbury Hospital, Shrewsbury, Shropshire SY3 8XQ, United Kingdom; Recruiting
Charlotte Owen, Phone: 01743 261000, Ext: 3387 or 3775, Email: charlotte.owen@sath.nhs.uk
Jim Moorcroft, Principal Investigator

Royal Adelaide Hospital, Adelaide, South Australia 5000, Australia; Recruiting
Kirsty Herewane, Phone: +61 (0) 8 8222 2872, Email: kirsty.herewane@health.sa.gov.au
Hugh Greville, Principal Investigator

Repatriation General Hospital, Daws Park, South Australia 5041, Australia; Recruiting
Toby Hunt, Phone: +61 (0) 8 8275 1008, Email: Toby.Hunt@health.sa.gov.au
Huw Davies, Principal Investigator

The Queen Elizabeth Hospital, Woodville, South Australia 5011, Australia; Recruiting
Karen Boath, Phone: +61 (0) 8 8222 7053, Email: Karen.Boath@health.sa.gov.au
Jonathan Polasek, Principal Investigator

South Carolina Pharmaceutical Research, Spartanburg, South Carolina 29303, United States; Recruiting
Anna Buica, Phone: 864-515-0092, Email: abuica@carolinamedresearch.com
Gregory Feldman, Principal Investigator

Sheffield Northern General Hospital, Sheffield, South Yorkshire S5 7AU, United Kingdom; Recruiting
Nathaniel Mills, Phone: 0114 271 5779, Email: nathaniel.mills@sth.nhs.uk
Omar Pirzada, Principal Investigator

Stafford Hospital, Stafford, Staffordshire ST16 3SA, United Kingdom; Recruiting
Heather Lawler, Phone: 01785230970, Email: heather.lawler@midstaffs.nhs.uk
Andrew Fairfax, Principal Investigator

University Hospital of North Tees, Stockton, Teeside TS19 8PE, United Kingdom; Recruiting
Nicola Bateman, Phone: 01642 624580, Email: Nicola.Bateman@nth.nhs.uk
Richard Harrison, Principal Investigator

Alamo Clinical Research Associates, San Antonio, Texas 78212, United States; Recruiting
Teresa Phillips, Phone: 210-223-3010, Email: tphillips@acra-sa.com
Peter Fornos, Principal Investigator

Llandough Hospital, Cardiff, Vale of Glamorgan CF64 2XX, United Kingdom; Recruiting
Claire Kilduff, Phone: 029 2071 5088, Email: drclairekilduff@hotmail.com
Ben Hope-Gill, Principal Investigator

St Vincent's Hospital, Fitzroy, Victoria 3065, Australia; Recruiting
Sue Brenton, Phone: +61 (0) 3 9288 3135, Email: Sue.BRENTON@svhm.org.au
Andrew Kyoong, Principal Investigator

Western Hospital, Footscray, Victoria 3011, Australia; Recruiting
Sue Casanelia, Phone: +61 3 8345 6804, Email: Sue.Casanelia@wh.org.au
Anne Marie Southcott, Principal Investigator

The Rooms of Dr C Steinfort, Geelong, Victoria 3220, Australia; Recruiting
Mandy Lowdell, Phone: +61 (3) 5221 1044, Email: cstein@pipeline.com.au
Chris Steinfort, Principal Investigator

Royal Melbourne Hospital, Melbourne, Victoria 3050, Australia; Recruiting
Annette Cross, Phone: +61 (0) 3 9342 8490, Email: annette.cross@mh.org.au
Abe Rubinfeld, Principal Investigator

Pulmonary Associates of Richmond, Inc, Richmond, Virginia 23225, United States; Recruiting
Laura Lincoln, Phone: 804-323-7002, Email: llincoln@paraccess.com
Ritsu Kuno, Principal Investigator

Birmingam Queen Elizabeth Hospital, Birmingham, West Midlands B15 2TH, United Kingdom; Recruiting
Anita Pye, Phone: 0121 697 8256, Email: anita.pye@uhb.nhs.uk
Robert Stockley, Principal Investigator

Wolverhampton New Cross Hospital, Wolverhampton, West Midlands WV10 0QP, United Kingdom; Recruiting
Jill Andrews, Phone: 01902 695066, Email: jillian.andrews@nhs.net
Paul Dawkins, Principal Investigator

Related publications:

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.

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. 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.

Daviskas E, Anderson SD. Hyperosmolar agents and clearance of mucus in the diseased airway. J Aerosol Med. 2006 Spring;19(1):100-9. Review.

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.

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. Review.

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.

Starting date: November 2009
Last updated: July 19, 2011