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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00455130 |
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Date of registration:
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02/04/2007 |
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Primary sponsor: |
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Public title:
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A Phase 2 Study to Determine the Safety and Efficacy of Inhaled Dry Powder Mannitol in Cystic Fibrosis
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Scientific title:
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Date of first enrolment:
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March 2004 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00455130 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Australia
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New Zealand
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Contacts
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Name:
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Brett Charlton |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pharmaxis |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Confirmed diagnosis of cystic fibrosis (sweat test/genotype)
2. Aged 8 years or older
3. Have FEV1 between 40% and 80% of predicted for height, age and gender OR a decrease
in FEV1 of 20% or more than that recorded 6-12 months previously.
4. As determined by the investigator, are capable and willing to
- Use the study diary as required for this protocol
- Able to perform all of the techniques necessary to measure lung function
- Able to administer the dry powder mannitol
5. Are capable of and have given informed consent
6. Clinically stable at study entry
Exclusion Criteria:
1. Investigators, site personnel directly affiliated with this study, and their
immediate families.
2. Subjects under the age of 8 years.
3. Subjects with currently active asthma
4. Subjects using hypertonic saline treatment in the last 2 weeks
5. Considered "terminally ill" or listed for transplantation
6. Requiring home oxygen or assisted ventilation
7. Colonisation with Burkholderia cepacia
8. Significant episode of hemoptysis (>60 mls) in the previous 12 months
9. Myocardial Infarction in the six months prior to enrolment.
10. Cerebral Vascular Accident in the six months prior to enrolment.
11. Ocular surgery in the three months prior to enrolment.
12. Abdominal surgery in the three months prior to enrolment.
13. Subjects who are breast feeding or pregnant.
14. Female subjects of reproductive capability, not using a reliable form of
contraception
15. Inability to obtain informed consent from the subject or subject's authorised
representative.
16. Subjects who have participated in another investigative drug study parallel to, or
within 4 weeks of study entry.
17. Known intolerance to mannitol or beta2 agonists.
18. Uncontrolled hypertension - systolic BP > 160 and or diastoli
Age minimum:
8 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Inhaled mannitol
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Secondary Outcome(s)
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Other measures of lung function
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Quality of life
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Safety
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Sputum microbiology
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Sputum rheology
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Secondary ID(s)
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DPM-CF-201
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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