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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01937325
Registration number
NCT01937325
Ethics application status
Date submitted
4/09/2013
Date registered
9/09/2013
Date last updated
25/07/2016
Titles & IDs
Public title
CPET in CF Patients With One G551D Mutation Taking VX770
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Scientific title
Airway Infection, Inflammatory Markers and Exercise Capacity in Patients With Cystic Fibrosis and at Least One G551D Mutation Taking VX770 (Ivacaftor)
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Secondary ID [1]
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CPET in CF
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Cystic fibrosis
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Respiratory
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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0
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Connective tissue diseases
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ivacaftor
Treatment: Drugs - placebo
Active Comparator: Ivacaftor - 150mg orally twice daily
Placebo Comparator: Placebo - Matching placebo
Treatment: Drugs: ivacaftor
active arm
Treatment: Drugs: placebo
active arm
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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exercise capacity
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Assessment method [1]
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Respiratory exercise testing, including spirometry and V02 max.
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Timepoint [1]
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one month, 3 months
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Secondary outcome [1]
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Inflammatory profile
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Assessment method [1]
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Cytokine levels (IL-1ß, IL-6, TNFa, IL-8, VEGF & Activin A) determined using cytometric bead analysis and / or ELISA
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Timepoint [1]
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One month, 3 months
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Eligibility
Key inclusion criteria
- All participants will have CF proven based on established criteria (sweat test,
genotype and phenotype).
- All participants will have at least one copy of the G551D mutation.
- All will be able to perform an exercise study and complete study questionnaires and
assessments.
- Age range will be between 16 and 75 years of age.
- Lung function inclusion will be above 25% predicted FEV1.
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Minimum age
16
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participants will not be included if they are unable to complete study assessments or
have had a known adverse reaction to Ivacaftor.
- Female participants will be excluded if found to return a positive pregnancy test at
screening.
- Participants will be excluded if using St. John's Wort or rifampicin (strong CYP3A
inducers).
- Participants with significant liver dysfunction will be excluded (ALT or ALT above 5
times upper limit of normal).
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Study design
Purpose of the study
Basic Science
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2016
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Actual
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Sample size
Target
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Accrual to date
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Final
20
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Alfred
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Ivacaftor will restore CFTR function in treated CF patients with the G551D mutation.
Improvement in ventilation, salt balance and well-being will contribute to better exercise
capacity at all levels of lung function. While potential improvements may be variable across
the spectrum of lung function, even small gains at low levels of FEV1 may have significant
benefit for some subjects.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01937325
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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John Wilson
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Address
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Alfred Health and Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01937325
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