- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00251056
Mannitol Dose Response Study in Cystic Fibrosis
August 27, 2008 updated by: Pharmaxis
A Phase IIa Randomised, Open Label, Dose Response Study to Determine the Optimum Dose of Dry Powder Mannitol Required to Generate Clinical Improvement In Patients With Cystic Fibrosis
Many cystic fibrosis patients die of lung failure caused by repeated lung infections from thick, sticky mucus.
Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology and replenishing the airway surface liquid layer in these patients, thereby enhancing the shift of stagnant mucus from the lungs.
The study aim is to determine the optimal dose of mannitol to generate clinical improvement in patients with cystic fibrosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Buenos Aires, Argentina
- Hospital Interzonal Especializado Materno Infantil (HIEMI)
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Caba, Argentina
- Hospital General de Niños
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Mendoza, Argentina
- Hospital Pediatrico Dr Humberto J Notti
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Buenos Aires
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La Plata, Buenos Aires, Argentina, B1904CSI
- Hospital de Niños Superiora Sor María Ludovica
-
-
Chaco
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Resistencia, Chaco, Argentina
- Hospital Pediatrico
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-
-
-
British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- BC Children's Hospital
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Vancouver, British Columbia, Canada, V6Z1Y6
- St Pauls Hospital
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Newfoundland and Labrador
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St Johns, Newfoundland and Labrador, Canada, A1B 3V6
- Janeway Children's Health and Rehabilitation Center
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
- Queen Elizabeth II Health Sciences Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- Hamilton Health Sciences Corporation
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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Toronto, Ontario, Canada
- St Michaels Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of cystic fibrosis (sweat test/genotype)
- 7 years or older
- FEV1 between 40% and 90% of predicted for height, age and gender.
- Able to perform acceptable-quality spirometry
- Clinically stable in the week up to study entry
- No additional antibiotics or additional oral steroids for a period of 14 days before study entry (routine antibiotics permitted)
Exclusion Criteria
- Currently active asthma
- Subjects colonized with Burkholderia cepacia or MRSA
- Considered "terminally ill" or listed for transplantation
- Requiring home oxygen or assisted ventilation
- Concurrent illness that in the investigators opinion may contribute to an increased and unacceptable risk if the subject was enrolled in the study (e.g. significant varicies, portal hypertension, cor pulmonale)
- Significant episode of haemoptysis (>60 mLs) in the previous 12 months
- Heart attack or stroke in last 3 months
- Known aortic or cerebral aneurysm
- Subjects who are breast feeding or pregnant.
- At risk females unwilling to use appropriate contraception to prevent pregnancy during the course of the study
- Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry.
- Known intolerance to mannitol or unable to take any form of bronchodilator medications.
- Uncontrolled hypertension, systolic BP > 200 or diastolic BP> than 100
- Concurrent use of beta blocker medication
- Concurrent use of hypertonic saline
Canada:
- Concurrent use of other pharmacological mucolytic agents other than Pulmozyme
Argentina:
- Concurrent use of other pharmacological mucolytic agents including Pulmozyme
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
|
120mg BD
40 mg BD
240mg BD
400mg BD
|
Active Comparator: 1
|
120mg BD
40 mg BD
240mg BD
400mg BD
|
Active Comparator: 3
|
120mg BD
40 mg BD
240mg BD
400mg BD
|
Active Comparator: 4
|
120mg BD
40 mg BD
240mg BD
400mg BD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
FEV1
Time Frame: 2 weeks
|
2 weeks
|
FVC
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
other measures of lung function
Time Frame: various
|
various
|
QOL
Time Frame: 2 weeks
|
2 weeks
|
sputum microbiology
Time Frame: 2 weeks
|
2 weeks
|
safety
Time Frame: 2 weeks
|
2 weeks
|
sputum clearance and cough
Time Frame: 2 weeks
|
2 weeks
|
respiratory symptoms
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elizabeth Tullis, MD, St Michaels Hospital, Toronto, Ontario, Canada
- Study Director: Brett Charlton, MBBS PhD, Pharmaxis Ltd, Sydney, NSW, Australia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
June 30, 2005
First Submitted That Met QC Criteria
November 7, 2005
First Posted (Estimate)
November 9, 2005
Study Record Updates
Last Update Posted (Estimate)
August 29, 2008
Last Update Submitted That Met QC Criteria
August 27, 2008
Last Verified
August 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DPM-CF-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cystic Fibrosis
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Hospital de Clinicas de Porto AlegreUnknownCystic Fibrosis | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in Children | Cystic Fibrosis With ExacerbationBrazil
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University of Colorado, DenverCystic Fibrosis FoundationTerminatedCystic Fibrosis-related Diabetes | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in ChildrenUnited States
-
Royal College of Surgeons, IrelandThe Hospital for Sick Children; Imperial College London; Erasmus Medical Center; University College Dublin and other collaboratorsActive, not recruitingCystic Fibrosis | Adherence, Medication | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in Children | Cystic Fibrosis Liver DiseaseUnited Kingdom, Ireland
-
Herlev and Gentofte HospitalCopenhagen University Hospital, DenmarkActive, not recruitingMyocardial Infarction | Heart Diseases | Heart Failure | Stroke | Cystic Fibrosis | Heart Failure, Diastolic | Heart Failure, Systolic | Left Ventricular Dysfunction | Cystic Fibrosis-related Diabetes | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of Pancreas | Cystic Fibrosis, Pulmonary | Cystic...Denmark
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The Hospital for Sick ChildrenCanadian Cystic Fibrosis FoundationActive, not recruitingCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in ChildrenCanada
-
Arrowhead PharmaceuticalsTerminatedCystic Fibrosis, PulmonaryAustralia, New Zealand
-
AzurRx SASCompletedCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of PancreasTurkey, Hungary
-
Dartmouth-Hitchcock Medical CenterTrustees of Dartmouth CollegeWithdrawnCystic Fibrosis-related Diabetes | Cystic Fibrosis Liver Disease | CF - Cystic FibrosisUnited States
-
University Hospital, BordeauxCompleted
-
Mack Biotech, Corp.Completed
Clinical Trials on mannitol
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Seoul National University HospitalUnknown
-
Shandong UniversityUnknown
-
PharmaxisCompletedCystic FibrosisUnited Kingdom
-
PharmaxisCompletedCystic FibrosisUnited Kingdom
-
PharmaxisWithdrawnCOPD | ExacerbationAustralia
-
University of British ColumbiaCompleted
-
Kuopio University HospitalJohn Hunter HospitalRecruiting
-
Abela Pharmaceuticals, Inc.Ohio State University; University of California, Irvine; Dr. Mahajan's Hospital...UnknownSevere Head TraumaUnited States
-
University of North Carolina, Chapel HillChiesi USA, Inc.RecruitingCystic FibrosisUnited States