Back to resultsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
inhaled mannitol
Placebo comparator
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis, mannitol, mucoactive
Eligibility Criteria
Inclusion Criteria:
- Have given written informed consent to participate in this study in accordance with local regulations
- 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)
- Be aged > 6 years old
- Have FEV1 >40 % and < 90% predicted
- Be able to perform all the techniques necessary to measure lung function
Exclusion Criteria:
- 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.
- Be considered "terminally ill" or eligible for lung transplantation
- Have had a lung transplant
- Be using nebulized hypertonic saline in the 4 weeks prior to visit 1
- Have had a significant episode of hemoptysis (>60 mL) in the three months prior to enrolment
- Have had a myocardial infarction in the three months prior to enrolment
- Have had a cerebral vascular accident in the three months prior to enrolment
- Have had major ocular surgery in the three months prior to enrolment
- Have had major abdominal, chest or brain surgery in the three months prior to enrolment
- Have a known cerebral, aortic or abdominal aneurysm
- Be breast feeding or pregnant, or plan to become pregnant while in the study
- Be using an unreliable form of contraception (female subjects at risk of pregnancy only)
- Be participating in another investigative drug study, parallel to, or within 4 weeks of visit 0
- Have a known allergy to mannitol
- Be using beta blockers
- Have uncontrolled hypertension - systolic BP > 190 and / or diastolic BP > 100
- 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
Be 'Mannitol Tolerance Test positive'
-
Sites / Locations
- University of Arizona
- Central Connecticut Cystic Fibrosis Center
- Nemours Childrens Clinic
- Batchelor Children's Research Institute - University of Miami
- Nemours Children's Clinic Orlando
- St Lukes CF Center of Idaho
- Northwestern Memorial Hospital
- Louisiana State University Health Sciences Center
- Maine Pediatric Specialty Group
- John Hopkins
- Massachusetts General Hospital
- University of Missouri
- Nebraska Medical Center - Nebraska Regional CF Center
- Women and Childrens Hospital of Buffalo
- The Toledo Hospital and Toledo Childrens Hospital
- University of Oklahoma Health Sciences Center
- St Christopher's Hospital for Children
- Medical University of SC
- Sanford Children's Specialty Clinic
- Le Bonheur Children's Medical Center
- Children's Chest Associates of Austin
- Baylor College of Medicine
- Alamo Clinical Research Associates
- Christus Santa Rosa Children's Hospital Cystic Fibrosis Center
- Pediatric Research, VCU Medical Centre
- Virginia Commonwealth University
- University of Washington medical centre
- University of Wisconsin
- Hospital Interzonal Dr Jose Penna Bahia Blanca
- Hospital de Ninos Dr Ricardo Gutierrez, Pediatria
- Hospital Gral. de Ninos Pedro de Elizalde
- Hospital de Ninos Superiora Sor Maria Ludovica de La Plata
- Hospital Pediatrico Dr Humberto J Notti
- Atención Integral en Reumatologia (AIR)
- Clinica Universitaria Privada Reina Fabiola - Universidad Cotolica de Cordoba
- Hospital de Ninos del la Santisima Trinidad
- Pediatrics Respiratory Medicine
- Hopital Universitaire Reine Fabiola
- UZ Brussel Laarbeeklan 101
- UZ Gasthuisberg
- Foothills medical center
- QEII Health Sciences Center
- The Children's Asthma Clinic
- Hopital Mere-Enfant
- Hopital Andre Mignot
- Hopital Jeanne de Flandre
- Hopital Femme-Mere-Enfents
- Hopital de Hautepierre
- Hopital Robert Debre
- University of Munich Medizinischen Klinik Innenstadt
- Universitats Kinderklinik Tubungen Wurzburg
- Universitats Kinderklinik Wurzburg
- Academic Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
active treatment
Outcomes
Primary Outcome Measures
Change in Absolute FEV1 From Baseline Over 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 Outcome Measures
Change in FEV1 From Baseline Over 26 Weeks - Dornase Users
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
Rate of Protocol Defined Pulmonary Exacerbations (PDPE)
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.
Hospitalisations Associated With Protocol Defined Pulmonary Exacerbations (PDPEs)
The number of hospitalisations is summarised and then the rate per person is analysed.
Antibiotic Use Associated With PDPEs
Number of courses per person in the 26 week period is summarised and then the rate per person analysed.
Absolute Change in FEV1 Percent Predicted at 26 Weeks
Change from baseline at 26 weeks in FEV1 percent predicted with BOCF for those with missing values at week 26
Change in FVC (mL) Across 26 Weeks
Change from baseline in forced vital capacity (FVC) across 26 weeks (measured at 6,14 and 26 weeks)
Change From Baseline FEF25-75 (mL/s) Over 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.
Sputum Weight at Baseline in Response to First Dose of Treatment
Sputum was collected during and for 30 minutes following the administration of the first dose of study treatment.
Full Information
NCT ID
NCT00630812
First Posted
February 27, 2008
Last Updated
October 6, 2020
Sponsor
Pharmaxis
Collaborators
ethica Clinical Research Inc., Europe: KasaConsult bvba, Hoegaarden, Belgium, Argentina: Resolution Latin America; Buenos Aires, Argentina
1. Study Identification
Unique Protocol Identification Number
NCT00630812
Brief Title
Long Term Administration of Inhaled Mannitol in Cystic Fibrosis
Official Title
Long Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmaxis
Collaborators
ethica Clinical Research Inc., Europe: KasaConsult bvba, Hoegaarden, Belgium, Argentina: Resolution Latin America; Buenos Aires, Argentina
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. The results of this study are to further investigate and confirm these findings in addition to examine the effect on antibiotic use and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects compared to a control treatment. An open label phase of 26 weeks duration will follow the blinded 26 week phase. During the open label phase all subjects will receive active treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
cystic fibrosis, mannitol, mucoactive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
318 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
active treatment
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
inhaled mannitol
Intervention Description
400 mg BD for 26 + 26 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Intervention Description
BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase
Primary Outcome Measure Information:
Title
Change in Absolute FEV1 From Baseline Over 26 Weeks
Description
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.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Change in FEV1 From Baseline Over 26 Weeks - Dornase Users
Description
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
Time Frame
26 weeks
Title
Rate of Protocol Defined Pulmonary Exacerbations (PDPE)
Description
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.
Time Frame
26 weeks
Title
Hospitalisations Associated With Protocol Defined Pulmonary Exacerbations (PDPEs)
Description
The number of hospitalisations is summarised and then the rate per person is analysed.
Time Frame
26 weeks
Title
Antibiotic Use Associated With PDPEs
Description
Number of courses per person in the 26 week period is summarised and then the rate per person analysed.
Time Frame
26 weeks
Title
Absolute Change in FEV1 Percent Predicted at 26 Weeks
Description
Change from baseline at 26 weeks in FEV1 percent predicted with BOCF for those with missing values at week 26
Time Frame
26 weeks
Title
Change in FVC (mL) Across 26 Weeks
Description
Change from baseline in forced vital capacity (FVC) across 26 weeks (measured at 6,14 and 26 weeks)
Time Frame
26 weeks
Title
Change From Baseline FEF25-75 (mL/s) Over 26 Weeks
Description
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.
Time Frame
26 weeks
Title
Sputum Weight at Baseline in Response to First Dose of Treatment
Description
Sputum was collected during and for 30 minutes following the administration of the first dose of study treatment.
Time Frame
up to 30 mins after first dose of trial treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have given written informed consent to participate in this study in accordance with local regulations
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)
Be aged > 6 years old
Have FEV1 >40 % and < 90% predicted
Be able to perform all the techniques necessary to measure lung function
Exclusion Criteria:
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.
Be considered "terminally ill" or eligible for lung transplantation
Have had a lung transplant
Be using nebulized hypertonic saline in the 4 weeks prior to visit 1
Have had a significant episode of hemoptysis (>60 mL) in the three months prior to enrolment
Have had a myocardial infarction in the three months prior to enrolment
Have had a cerebral vascular accident in the three months prior to enrolment
Have had major ocular surgery in the three months prior to enrolment
Have had major abdominal, chest or brain surgery in the three months prior to enrolment
Have a known cerebral, aortic or abdominal aneurysm
Be breast feeding or pregnant, or plan to become pregnant while in the study
Be using an unreliable form of contraception (female subjects at risk of pregnancy only)
Be participating in another investigative drug study, parallel to, or within 4 weeks of visit 0
Have a known allergy to mannitol
Be using beta blockers
Have uncontrolled hypertension - systolic BP > 190 and / or diastolic BP > 100
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
Be 'Mannitol Tolerance Test positive'
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moira L Aitken, MD
Organizational Affiliation
University of Washington Medical Centre, Seattle WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Central Connecticut Cystic Fibrosis Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
66106
Country
United States
Facility Name
Nemours Childrens Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Batchelor Children's Research Institute - University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Nemours Children's Clinic Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
St Lukes CF Center of Idaho
City
Idaho
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Louisiana State University Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Maine Pediatric Specialty Group
City
Portland
State/Province
Maine
ZIP/Postal Code
4102
Country
United States
Facility Name
John Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
62114
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Nebraska Medical Center - Nebraska Regional CF Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5300
Country
United States
Facility Name
Women and Childrens Hospital of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
The Toledo Hospital and Toledo Childrens Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
St Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Medical University of SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Sanford Children's Specialty Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States
Facility Name
Le Bonheur Children's Medical Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Children's Chest Associates of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alamo Clinical Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Christus Santa Rosa Children's Hospital Cystic Fibrosis Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Pediatric Research, VCU Medical Centre
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
University of Washington medical centre
City
Seattle
State/Province
Washington
ZIP/Postal Code
58103
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53972
Country
United States
Facility Name
Hospital Interzonal Dr Jose Penna Bahia Blanca
City
Bahia Blanca
State/Province
Buenos Aires
ZIP/Postal Code
8000
Country
Argentina
Facility Name
Hospital de Ninos Dr Ricardo Gutierrez, Pediatria
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425EFD
Country
Argentina
Facility Name
Hospital Gral. de Ninos Pedro de Elizalde
City
Ciudad Autonoma
State/Province
Buenos Aires
ZIP/Postal Code
C1270AAN
Country
Argentina
Facility Name
Hospital de Ninos Superiora Sor Maria Ludovica de La Plata
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Hospital Pediatrico Dr Humberto J Notti
City
Guaymallen
State/Province
Mendosa
ZIP/Postal Code
5519
Country
Argentina
Facility Name
Atención Integral en Reumatologia (AIR)
City
Buenos Aires
ZIP/Postal Code
C1426AAL
Country
Argentina
Facility Name
Clinica Universitaria Privada Reina Fabiola - Universidad Cotolica de Cordoba
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Hospital de Ninos del la Santisima Trinidad
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Pediatrics Respiratory Medicine
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Hopital Universitaire Reine Fabiola
City
Bruxelles
State/Province
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
UZ Brussel Laarbeeklan 101
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Foothills medical center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N1
Country
Canada
Facility Name
QEII Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H3A7
Country
Canada
Facility Name
The Children's Asthma Clinic
City
London
State/Province
Ontario
ZIP/Postal Code
N6A1V2
Country
Canada
Facility Name
Hopital Mere-Enfant
City
Nantes
State/Province
Cedex
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Andre Mignot
City
Le Chesnay
State/Province
Cedix
ZIP/Postal Code
78157
Country
France
Facility Name
Hopital Jeanne de Flandre
City
Lille CEDEX
State/Province
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Femme-Mere-Enfents
City
Bron Cedex
State/Province
Lyon
ZIP/Postal Code
69677
Country
France
Facility Name
Hopital de Hautepierre
City
Strasbourg CEDEX
State/Province
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hopital Robert Debre
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
University of Munich Medizinischen Klinik Innenstadt
City
Munchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Universitats Kinderklinik Tubungen Wurzburg
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitats Kinderklinik Wurzburg
City
Wurzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Academic Medical Centre
City
Amsterdam
ZIP/Postal Code
1100DD
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
16551221
Citation
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.
Results Reference
background
PubMed Identifier
15691238
Citation
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.
Results Reference
background
PubMed Identifier
12396422
Citation
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.
Results Reference
background
PubMed Identifier
11921459
Citation
Robinson M, Bye PT. Mucociliary clearance in cystic fibrosis. Pediatr Pulmonol. 2002 Apr;33(4):293-306. doi: 10.1002/ppul.10079.
Results Reference
background
PubMed Identifier
11171717
Citation
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.
Results Reference
background
PubMed Identifier
10543292
Citation
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.
Results Reference
background
PubMed Identifier
10351929
Citation
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.
Results Reference
background
PubMed Identifier
9426077
Citation
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.
Results Reference
background
PubMed Identifier
18339790
Citation
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.
Results Reference
background
PubMed Identifier
32358807
Citation
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.
Results Reference
derived
PubMed Identifier
22198974
Citation
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.
Results Reference
derived
Learn more about this trial
Long Term Administration of Inhaled Mannitol in Cystic Fibrosis
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