Long Term Administration of Inhaled Mannitol in Cystic Fibrosis
NCT ID: NCT00630812
Last Updated: 2020-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
318 participants
INTERVENTIONAL
2008-09-30
2010-11-30
Brief Summary
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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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A
active treatment
inhaled mannitol
400 mg BD for 26 + 26 weeks
B
Placebo comparator
BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
Interventions
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inhaled mannitol
400 mg BD for 26 + 26 weeks
Placebo comparator
BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
Eligibility Criteria
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Inclusion Criteria
2. Have a confirmed diagnosis of cystic fibrosis (positive sweat chloride value ≥ 60 mEq/L) and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype)
3. Be aged \> 6 years old
4. Have FEV1 \>40 % and \< 90% predicted
5. Be able to perform all the techniques necessary to measure lung function
Exclusion Criteria
2. Be considered "terminally ill" or eligible for lung transplantation
3. Have had a lung transplant
4. Be using nebulized hypertonic saline in the 4 weeks prior to visit 1
5. Have had a significant episode of hemoptysis (\>60 mL) in the three months prior to enrolment
6. Have had a myocardial infarction in the three months prior to enrolment
7. Have had a cerebral vascular accident in the three months prior to enrolment
8. Have had major ocular surgery in the three months prior to enrolment
9. Have had major abdominal, chest or brain surgery in the three months prior to enrolment
10. Have a known cerebral, aortic or abdominal aneurysm
11. Be breast feeding or pregnant, or plan to become pregnant while in the study
12. Be using an unreliable form of contraception (female subjects at risk of pregnancy only)
13. Be participating in another investigative drug study, parallel to, or within 4 weeks of visit 0
14. Have a known allergy to mannitol
15. Be using beta blockers
16. Have uncontrolled hypertension - systolic BP \> 190 and / or diastolic BP \> 100
17. Have a condition or be 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
18. Be 'Mannitol Tolerance Test positive'
\-
6 Years
ALL
No
Sponsors
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ethica Clinical Research Inc.
INDUSTRY
Europe: KasaConsult bvba, Hoegaarden, Belgium
INDUSTRY
Resolution Latin America
OTHER
Syntara
INDUSTRY
Responsible Party
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Principal Investigators
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Moira L Aitken, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington Medical Centre, Seattle WA
Locations
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University of Arizona
Tucson, Arizona, United States
Central Connecticut Cystic Fibrosis Center
Hartford, Connecticut, United States
Nemours Childrens Clinic
Jacksonville, Florida, United States
Batchelor Children's Research Institute - University of Miami
Miami, Florida, United States
Nemours Children's Clinic Orlando
Orlando, Florida, United States
St Lukes CF Center of Idaho
Idaho City, Idaho, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States
Maine Pediatric Specialty Group
Portland, Maine, United States
John Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Missouri
Columbia, Missouri, United States
Nebraska Medical Center - Nebraska Regional CF Center
Omaha, Nebraska, United States
Women and Childrens Hospital of Buffalo
Buffalo, New York, United States
The Toledo Hospital and Toledo Childrens Hospital
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
St Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Medical University of SC
Charleston, South Carolina, United States
Sanford Children's Specialty Clinic
Sioux Falls, South Dakota, United States
Le Bonheur Children's Medical Center
Memphis, Tennessee, United States
Children's Chest Associates of Austin
Austin, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Alamo Clinical Research Associates
San Antonio, Texas, United States
Christus Santa Rosa Children's Hospital Cystic Fibrosis Center
San Antonio, Texas, United States
Pediatric Research, VCU Medical Centre
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington medical centre
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Hospital Interzonal Dr Jose Penna Bahia Blanca
Bahía Blanca, Buenos Aires, Argentina
Hospital de Ninos Dr Ricardo Gutierrez, Pediatria
CABA, Buenos Aires, Argentina
Hospital Gral. de Ninos Pedro de Elizalde
Ciudad Autonoma, Buenos Aires, Argentina
Hospital de Ninos Superiora Sor Maria Ludovica de La Plata
La Plata, Buenos Aires, Argentina
Hospital Pediatrico Dr Humberto J Notti
Villa Nueva, Mendoza Province, Argentina
Atención Integral en Reumatologia (AIR)
Buenos Aires, , Argentina
Clinica Universitaria Privada Reina Fabiola - Universidad Cotolica de Cordoba
Córdoba, , Argentina
Hospital de Ninos del la Santisima Trinidad
Córdoba, , Argentina
Pediatrics Respiratory Medicine
Edegem, Antwerpen, Belgium
Hopital Universitaire Reine Fabiola
Brussels, Brussels Capital, Belgium
UZ Brussel Laarbeeklan 101
Brussels, , Belgium
UZ Gasthuisberg
Leuven, , Belgium
Foothills medical center
Calgary, Alberta, Canada
QEII Health Sciences Center
Halifax, Nova Scotia, Canada
The Children's Asthma Clinic
London, Ontario, Canada
Hopital Mere-Enfant
Nantes, Cedex, France
Hopital Andre Mignot
Le Chesnay, Cedix, France
Hopital Jeanne de Flandre
Lille, Lille, France
Hopital Femme-Mere-Enfents
Bron, Lyon, France
Hopital de Hautepierre
Strasbourg, Strasbourg, France
Hopital Robert Debre
Paris, , France
University of Munich Medizinischen Klinik Innenstadt
München, , Germany
Universitats Kinderklinik Tubungen Wurzburg
Tübingen, , Germany
Universitats Kinderklinik Wurzburg
Würzburg, , Germany
Academic Medical Centre
Amsterdam, , Netherlands
Countries
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References
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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.
Robinson M, Bye PT. Mucociliary clearance in cystic fibrosis. Pediatr Pulmonol. 2002 Apr;33(4):293-306. doi: 10.1002/ppul.10079.
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.
Robinson M, Daviskas E, Eberl S, Baker J, Chan HK, Anderson SD, Bye PT. The effect of inhaled mannitol on bronchial mucus clearance in cystic fibrosis patients: a pilot study. Eur Respir J. 1999 Sep;14(3):678-85. doi: 10.1034/j.1399-3003.1999.14c30.x.
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, Brannan JD, Chan HK, Eberl S, Bautovich G. Inhalation of dry-powder mannitol increases mucociliary clearance. Eur Respir J. 1997 Nov;10(11):2449-54. doi: 10.1183/09031936.97.10112449.
Jaques A, Daviskas E, Turton JA, McKay K, Cooper P, Stirling RG, Robertson CF, Bye PTP, LeSouef PN, Shadbolt B, Anderson SD, Charlton B. Inhaled mannitol improves lung function in cystic fibrosis. Chest. 2008 Jun;133(6):1388-1396. doi: 10.1378/chest.07-2294. Epub 2008 Mar 13.
Nevitt SJ, Thornton J, Murray CS, Dwyer T. Inhaled mannitol for cystic fibrosis. Cochrane Database Syst Rev. 2020 May 1;5(5):CD008649. doi: 10.1002/14651858.CD008649.pub4.
Aitken ML, Bellon G, De Boeck K, Flume PA, Fox HG, Geller DE, Haarman EG, Hebestreit HU, Lapey A, Schou IM, Zuckerman JB, Charlton B; CF302 Investigators. Long-term inhaled dry powder mannitol in cystic fibrosis: an international randomized study. Am J Respir Crit Care Med. 2012 Mar 15;185(6):645-52. doi: 10.1164/rccm.201109-1666OC. Epub 2011 Dec 28.
Other Identifiers
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DPM-CF-302
Identifier Type: -
Identifier Source: org_study_id
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