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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/NCT00669331
Registration number
NCT00669331
Ethics application status
Date submitted
28/04/2008
Date registered
30/04/2008
Date last updated
29/04/2016
Titles & IDs
Public title
Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis
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Scientific title
: A Phase III Multicenter, Randomized, Parallel Group, Controlled, Double Blind Study to Investigate the Safety and Efficacy of Inhaled Mannitol Over 12 Months in the Treatment of Bronchiectasis.
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Secondary ID [1]
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DPM-B-305
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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:
Bronchiectasis
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Inhaled mannitol
Treatment: Drugs - Matched control
Experimental: Mannitol - Inhaled mannitol 400mg
Placebo Comparator: Control - Matched control - inhaled mannitol 50mg
Treatment: Drugs: Inhaled mannitol
400mg dose of Mannitol BD (twice a day) for 52 weeks
Treatment: Drugs: Matched control
50mg dose of Mannitol BD (twice a day) for 52 weeks
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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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Rate of Graded Pulmonary Exacerbations
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Assessment method [1]
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A graded pulmonary exacerbation was defined as a worsening in signs and symptoms requiring a change in treatment (Center for Drug Evaluation and Research (CDER), 2007). Grade I was required 3 main signs and symptoms, Grade II 2 main signs and symptoms and Grade III 1 main and one or more minor signs and symptoms. Main signs and symptoms were increased cough, sputum volume or sputum purulence. Minor were upper respiratory tract infection, fever, increased wheezing, increased dyspnea, increase in respiratory rate, increase in cardiac frequency of >20%, and increased malaise, fatigue or lethargy. Rate is defined as the number of all GPE events observed in one treatment year
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Timepoint [1]
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52 weeks
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Secondary outcome [1]
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Quality of Life as Measured by the St. Georges Respiratory Questionnaire (SGRQ) Total Score
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Assessment method [1]
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The SGRQ was collected at baseline, week 6, week 16, week 28, week 40 and week 52. Change in total score was calculated from baseline. Total scores are a weighted sum across all questions. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. Higher scores indicate lower quality of life. Outcome data table gives the raw mean total score at each visit.
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Timepoint [1]
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52 weeks
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Secondary outcome [2]
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Antibiotic Use Prescribed for Treated Pulmonary Exacerbations
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Assessment method [2]
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Rate of antibiotic treated graded pulmonary exacerbations, using the same definition of a graded pulmonary exacerbation as the primary endpoint. A graded pulmonary exacerbation was considered to be anti-biotic treated if use of oral, IV or inhaled antibiotic use was recorded related to the GPE event.
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Timepoint [2]
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52 weeks
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Secondary outcome [3]
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Time to First Graded Exacerbation
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Assessment method [3]
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Time to first graded exacerbation is defined as the duration (in months) from the randomisation date to the start of the first reported graded PE during the on-treatment period. Patients without reported graded PE event will be censored at the last participation.
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Timepoint [3]
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52 weeks
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Secondary outcome [4]
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Duration of Graded Exacerbations
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Assessment method [4]
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Duration of graded exacerbations is defined as the number of days with graded PE within one treatment year. Mean days estimated via negative binomial model with treatment, region and baseline pulmonary exacerbation rate as predictors, with log of follow-up time as the offset variable
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Timepoint [4]
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52 weeks
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Secondary outcome [5]
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Sputum Volume
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Assessment method [5]
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24 hour sputum weight, measured at baseline, week 6, week 16, week 28, week 40, week 52
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Timepoint [5]
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52 weeks
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Secondary outcome [6]
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Daytime Sleepiness Scores
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Assessment method [6]
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Epworth Sleepiness Scale (ESS) score was calculated as the sum of scores for each of eight individual questions, such that a total score of zero represents no daytime sleepiness, and a total score of 24 represents the maximum degree of daytime sleepiness. Measured at baseline, 6 weeks, 16 weeks, 28 weeks, 40 weeks, 52 weeks
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Timepoint [6]
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52 weeks
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Secondary outcome [7]
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Lung Function - Change in FEV1 (Forced Expiratory Volume in One Second)
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Assessment method [7]
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Timepoint [7]
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52 weeks
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Secondary outcome [8]
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Lung Function - Change in FVC (Forced Vital Capacity)
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Assessment method [8]
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Timepoint [8]
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52 weeks
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Secondary outcome [9]
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Lung Function - Change in FEV1/FVC
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Assessment method [9]
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FEV1 expressed as a ratio of FVC. Endpoint is expressed as a percentage ie FEV1/FVC*100
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Timepoint [9]
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52 weeks
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Secondary outcome [10]
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Lung Function - Change in FEF25-75 (Forced Expiratory Flow Rate Averaged Over 25th -75th Percentile of FVC)
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Assessment method [10]
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Timepoint [10]
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52 weeks
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Secondary outcome [11]
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Safety Profile - Sputum Microbiology
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Assessment method [11]
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sputum microbiology assessed as the presence of abnormal flora in sputum sample taken at any post baseline visit
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Timepoint [11]
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52 weeks
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Secondary outcome [12]
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Safety Profile - Clinical Chemistry
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Assessment method [12]
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Clinical chemistry was assessed as clinically significant abnormal liver function test and clinically significant abnormal urea/electrolyte test at any point post baseline.
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Timepoint [12]
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52 weeks
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Secondary outcome [13]
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Safety Profile - Hematology
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Assessment method [13]
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hematology assessed as clinically significant abnormal FBC (Full Blood count) at any point post baseline.
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Timepoint [13]
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52 weeks
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Secondary outcome [14]
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• (Exploratory) Number of Hospitalizations Due to Pulmonary Exacerbations
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Assessment method [14]
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Mean rate of hospitalisations (number/year) summarised and analysed to take account of differing follow-up times.
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Timepoint [14]
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52 weeks
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Eligibility
Key inclusion criteria
Inclusion Criteria
1. Have given written informed consent to participate in this study in accordance with
local regulations
2. Have documented evidence of confirmed diagnosis of (non-cystic fibrosis)
bronchiectasis by computed tomography (CT), High resolution computed tomography (HRCT)
or bronchogram
3. Be aged 18 - 85 years inclusive, male and female
4. Have FEV1 (Forced expiratory volume in one second) = 40% and =85% predicted* and =1.0L
(*according to NHANES III predicted tables) measured at Visit 0A (V0A)
5. Clinician documented history of at least 2 pulmonary exacerbations, each requiring
antibiotic therapy, in the last 12 months prior to Visit 0A (V0A) and a total of at
least 4 in the last 2 years prior to Visit 0A
6. Have a total SGRQ (St George's respiratory questionnaire) score of =30 at Visit 0B
(V0B)
7. Have a production of =10g of sputum at Visit 0B Have reported chronic sputum
production of =1 tablespoon (15mL) per day on the majority of days in the 3 months
prior to Visit 0A
8. Be able to perform all the techniques necessary to measure lung function
9. Have FEV1 =40% predicted* and =1.0L (*according to NHANES III 1999 predicted tables)
measured at V0B (Baseline result prior to MTT (Mannitol Tolerance Test)
administration)
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Minimum age
18
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Maximum age
85
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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
Exclusion Criteria
1. Be 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.
2. Have bronchiectasis as a consequence of cystic fibrosis or focal endobronchial lesion
or otherwise curable causes (e.g. foreign body aspiration)
3. Be considered "terminally ill" or listed for transplantation
4. Be using hypertonic saline in the 14 days prior to commencing Visit 0B or thereafter
at any time during the study
5. Have previously used inhaled mannitol (Bronchitol) for more than a day
6. Have had a significant episode of hemoptysis (>60 mL) in the previous 6 months
7. Have had rescue antibiotics in the 4 weeks prior to V0B (chronic background antibiotic
therapy accepted)
8. Have smoked within the last 3 months and must not smoke during their participation in
the study
9. Have had a myocardial infarction in the three months prior to Visit 0A
10. Have had a cerebral vascular accident in the three months prior to Visit 0A
11. Have had major ocular surgery in the three months prior to Visit 0A
12. Have had major abdominal, chest or brain surgery in the three months prior to Visit 0A
13. Have a known cerebral, aortic or abdominal aneurysm
14. Have actively treated Mycobacterium tuberculosis
15. Have actively treated or unstable nontuberculous mycobacterial (NTM)infection or be
under consideration for NTM treatment in the next 12 months
16. Have unstable Allergic bronchopulmonary aspergillosis (ABPA) requiring steroid therapy
(=5mg dose oral steroids in stable ABPA accepted)
17. Have end stage interstitial lung disease
18. Have active malignancy including melanoma (other skin carcinomas exempted). Remissions
from any malignancy =2 years also exempted
19. Be breast feeding or pregnant, or plan to become pregnant while in the study
20. Be using an unreliable form of contraception (female subjects at risk of pregnancy
only)
21. Be participating in another investigational drug study, parallel to, or within 4 weeks
of Visit 0A
22. Have a known intolerance to mannitol or ß2-agonists
23. Have uncontrolled hypertension - e.g. for adults: systolic blood pressure (BP) > 190
and or diastolic BP > 100
24. Subject has a condition or is 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
25. Have previously been screen failed for the study (exceptions - see section 3.3.2
Eligibility Criteria - Rescreening)
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Study design
Purpose of the study
Treatment
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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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
1/11/2009
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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
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Actual
1/01/2014
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Sample size
Target
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Accrual to date
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Final
485
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Woolcock Institute of Medical Research - Glebe
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St George Hospital - Kogarah
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The Prince Charles Hospital - Chermside
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Royal Adelaide Hospital - Adelaide
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Repatriation General Hospital - Daws Park
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The Queen Elizabeth Hospital - Woodville
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St Vincent's Hospital - Fitzroy
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Western Hospital - Footscray
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The Rooms of Dr C Steinfort - Geelong
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Royal Melbourne Hospital - Melbourne
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2037 - Glebe
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2217 - Kogarah
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4032 - Chermside
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5000 - Adelaide
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5041 - Daws Park
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5011 - Woodville
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3065 - Fitzroy
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3011 - Footscray
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3220 - Geelong
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Recruitment postcode(s) [10]
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3050 - Melbourne
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Recruitment outside Australia
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Colorado
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Connecticut
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Hessen
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Wrexham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Syntara
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
No gold standard therapy exists for clearing mucus from the airways of patients with
bronchiectasis. While rhDNase has a proven place in the treatment of cystic fibrosis (CF), it
failed to improve Forced expiratory volume in one second (FEV1) in a short-term non-CF
bronchiectasis study and has been shown to be detrimental after 6 months therapy in non CF
bronchiectasis, moreover it has no proven effect on mucociliary clearance. Hypertonic saline
has been shown to have a comparable mode of action to inhaled mannitol, but has yet to be
examined as a long term treatment option in bronchiectasis.
The purpose of this study is to examine the efficacy and safety of 52 weeks treatment with
inhaled mannitol in subjects with non-cystic fibrosis bronchiectasis. Previous studies with
inhaled mannitol have demonstrated improvement in mucociliary clearance; mucus rehydration;
improvement in quality of life and respiratory symptoms in patients with bronchiectasis and
pulmonary function in cystic fibrosis. The results of this current study in combination with
a recently completed 3 month study seek to confirm these early findings and to extend the
evidence to support its use as a mucoactive therapy in subjects with bronchiectasis.
We hypothesize that mannitol will improve the overall health and hygiene of the lung through
regular and effective clearing of the mucus load. As a consequence of the reduction in mucus
load and inflammatory process, the frequency of bronchiectasis related pulmonary
exacerbations and the need for exacerbation related antibiotic treatment should fall. Days in
hospital and community health care costs are expected to change in line with improvements in
respiratory health.
Finally, we plan to demonstrate that inhaled mannitol is safe and well tolerated over a 52
week period. We will test these hypotheses using 400 mg mannitol twice daily (BD) against
control.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00669331
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Trial related presentations / publications
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, Eberl S, Young IH. Effect of increasing doses of mannitol on mucus clearance in patients with bronchiectasis. Eur Respir J. 2008 Apr;31(4):765-72. doi: 10.1183/09031936.00119707. Epub 2007 Dec 5.
Daviskas E, Anderson SD, Young IH. Inhaled mannitol changes the sputum properties in asthmatics with mucus hypersecretion. Respirology. 2007 Sep;12(5):683-91. doi: 10.1111/j.1440-1843.2007.01107.x.
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.
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.
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Diana Bilton, MD
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Brompton Hospital London UK
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00669331
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