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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00645788
Registration number
NCT00645788
Ethics application status
Date submitted
26/03/2008
Date registered
28/03/2008
Date last updated
9/06/2014
Titles & IDs
Public title
Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis
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Scientific title
Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Inhaled Ciprofloxacin Compared to Placebo in Subjects With Cystic Fibrosis
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Secondary ID [1]
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2008-008314-40
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Secondary ID [2]
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12429
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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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0
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Cystic fibrosis
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Respiratory
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0
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
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0
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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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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 - Ciprofloxacin (Cipro Inhale, BAYQ3939)
Treatment: Drugs - Placebo
Treatment: Drugs - Ciprofloxacin (Cipro Inhale, BAYQ3939)
Treatment: Drugs - Placebo
Experimental: 32.50 mg Ciprofloxacin DPI (BAYQ3939) - 32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
Experimental: 48.75 mg Ciprofloxacin DPI (BAYQ3939) - 48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
Placebo comparator: Matching Placebo for 32.50 mg - Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
Placebo comparator: Matching Placebo for 48.75 mg - Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
Treatment: Drugs: Ciprofloxacin (Cipro Inhale, BAYQ3939)
32.5 mg ciprofloxacin DPI corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days
Treatment: Drugs: Placebo
50 mg matching placebo powder formulation twice a day for 28 days
Treatment: Drugs: Ciprofloxacin (Cipro Inhale, BAYQ3939)
48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2)
Treatment: Drugs: Placebo
75 mg matching placebo powder formulation twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2)
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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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Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28-30
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Assessment method [1]
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FEV1: The maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.
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Timepoint [1]
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Baseline and End of treatment (Day 28-30)
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Secondary outcome [1]
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Change From Baseline in FEV1 at Visits 4, 5, and Follow-up Visits 8 and 9
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Assessment method [1]
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FEV1: The maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.
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Timepoint [1]
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Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).
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Secondary outcome [2]
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Change From Baseline in P. Aeruginosa Density in the Sputum at Visits 4, 5, 7, 8 and 9
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Assessment method [2]
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Density of P. aeruginosa in the sputum is expressed as log10 of colony forming units (CFU)/gram (g). The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.
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Timepoint [2]
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Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).
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Secondary outcome [3]
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Time to First Pulmonary Exacerbation Requiring Intervention
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Assessment method [3]
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Pulmonary exacerbations: Assessment of pulmonary exacerbation was conducted by the treating physician as part of the physical examination. Pulmonary exacerbation was defined by chest examination findings and any or all of the following symptoms: decreased exercise tolerance, increased cough, increased sputum/cough congestion, school or work absenteeism, increased adventitial sounds on the lung examination, and decreased appetite.
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Timepoint [3]
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Up to visit 9 (Day 56-60)
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Secondary outcome [4]
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Change From Baseline in Forced Vital Capacity (FVC) at Visits 4, 5, 7, 8 and 9
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Assessment method [4]
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FVC: The maximal volume of air exhaled with maximally forced effort from a maximal inspiration, ie, vital capacity performed with a maximally forced expiratory effort expressed in liters at BTPS (body temperature and ambient pressure saturated with water vapor). The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.
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Timepoint [4]
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Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).
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Secondary outcome [5]
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Change From Baseline in Forced Expiratory Flow (FEF 25-75%) at Visits 4, 5, 7, 8 and 9
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Assessment method [5]
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FEF 25-75% (also known as the maximum midexpiratory flow \[MMEF\]): The mean forced expiration flow over the middle half of the forced vital capacity (FVC). It was taken from the blow with the largest sum of FEV1 and FVC. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.
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Timepoint [5]
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Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).
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Secondary outcome [6]
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Number of Participants Developing Ciprofloxacin-resistant Mucoid P.Aeruginosa Isolates
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Assessment method [6]
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Susceptibility and resistance assessment of a bacterial isolate was performed using the established Food and Drug Administration (FDA) susceptibility criteria for ciprofloxacin. The susceptibility criteria in mg/L are =1 for organisms Enterobacteriaciae, P. aeruginosa, Staphylococcus species and S. pneumoniae. The "susceptible" bacterial species likely responds to typical doses of ciprofloxacin. The resistance criteria for ciprofloxacin in mg/L are =4 mg/L for the same organisms. Resistance indicates that the bacteria is less likely to respond to typical doses of ciprofloxacin therapy.
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Timepoint [6]
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Baseline and up to visit 9 (day 56-60)
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Secondary outcome [7]
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Number of Participants Developing Ciprofloxacin-resistant Non-mucoid P.Aeruginosa Isolates
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Assessment method [7]
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Susceptibility and resistance assessment of a bacterial isolate was performed using the established Food and Drug Administration (FDA) susceptibility criteria for ciprofloxacin. The susceptibility criteria in mg/L are =1 for organisms Enterobacteriaciae, P. aeruginosa, Staphylococcus species and S. pneumoniae. The "susceptible" bacterial species likely responds to typical doses of ciprofloxacin. The resistance criteria for ciprofloxacin in mg/L are =4 mg/L for the same organisms. Resistance indicates that the bacteria is less likely to respond to typical doses of ciprofloxacin therapy.
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Timepoint [7]
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Baseline and up to visit 9 (day 56-60)
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Secondary outcome [8]
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Effect of Ciprofloxacin DPI Treatment on Quality of Life Measured by Cystic Fibrosis Quality of Life Questionnaire Revised (CFQ-R), Respiratory Scale
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Assessment method [8]
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The CF quality of life questionnaire revised (CFQ-R), a validated disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents and adults with cystic fibrosis (CF). It is self-administered and consists of 44 items, divided into 12 generic and disease-specific scales. The scale includes physical functioning, role, vitality, emotional functioning, social functioning, body image, eating disturbances, treatment burden, health perceptions, weight, respiratory symptoms, and digestive symptoms. Scale range: 0 to 100 (maximum). Better outcome with higher values.
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Timepoint [8]
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Baseline and Visit 7 (Day 28-30) and Visit 9 (Day 56 -60)
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Secondary outcome [9]
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Plasma Concentrations of Ciprofloxacin From Selected Participants During Treatment
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Assessment method [9]
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Plasma concentrations measured using validated high pressure liquid chromatography-mass specroscopy/mass spectroscopy (HPLC-MS/MS) methods in selected patients at predefined time windows to contribute pharmacokinetic (PK) information for an inter-study population PK evaluation. Sampling window for Plasma: Predose (trough level), \<15 min, 2.0 - 2.5 hour, and 4.0 - 7.0 hours after the end of inhalation. Number of samples vary at different time points.
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Timepoint [9]
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Up to visit 7 (Day 28-30)
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Secondary outcome [10]
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Sputum Concentrations of Ciprofloxacin From Selected Participants During Treatment
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Assessment method [10]
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Sputum concentrations measured using validated HPLC-MS/MS methods in selected patients to contribute kinetic information for an inter-study population sputum kinetic evaluation. Number of samples vary at different time points.
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Timepoint [10]
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Up to visit 7 (Day 28-30)
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Secondary outcome [11]
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Number of Participants With the Occurrence of Drug Induced Bronchospasms
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Assessment method [11]
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Bronchospasm reported as adverse event: Bronchospasm defined as \>=15% drop in FEV1, and may also include allergic and excercise-induced bronchospasm. Drug-induced bronchospasm: Treatment-emergent bronchospasm was defined as \>=15% drop in FEV1 in the ITT/safety population. Note: One of the bronchospasm events was considered a serious adverse event, and it was not included under "other" adverse events. A sum of bronchospasm events was 1+6=7.
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Timepoint [11]
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Up to visit 9 (Day 56-60)
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Eligibility
Key inclusion criteria
* Subjects, or their legal representative(s), must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures
* Children (12 - 17 years) or adults >/=18 years
* Documented diagnosis Cystic Fibrosis (CF):
* documented sweat chloride >/=60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT) or nasal potential difference
* either homozygous for ?F508 genetic mutation or a compound heterozygous for 2 known CF mutations
* and clinical findings consistent with CF
* Chronic colonization with P. aeruginosa defined as a positive respiratory tract culture (sputum or throat swab) within 12 months prior to screening and at screening (Note: subjects with negative culture at screening can, at the discretion of the investigator, be rescreened at a later date)
* Ability to perform reproducible pulmonary function tests
* Ability to produce sputum (noninduced)
* Stable pulmonary status, FEV1 >/=35% to </=75% (intraindividual variability +/-10% of absolute value). Note: The subject is not eligible for enrollment if the variability results in (or leads to) an FEV1 <35%.
* Room air oximetry >/=88% saturation
* Off antibiotics (except macrolide) and Cipro (oral) for at least 30 days prior to the administration of study drug for pulmonary exacerbation
* Stable regimen of standard CF treatment including chest physiotherapies and exercise regimens should not change during the 30 days prior to the administration of study drug and during the study (including macrolide administration unchanged in the previous 30 days)
* Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period
* Women who are willing to use an adequate method of contraception for 3 months after receiving the study drug. Adequate methods of contraception include vasectomy or condom use by their partners, diaphragm with spermicidal gel, coil (intrauterine device), surgical sterilization or oral contraceptive
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Minimum age
12
Years
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Maximum age
No limit
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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
* Findings on screening history and physical examination unrelated to CF that could potentially affect the efficacy measurements (eg, chest surgery)
* Subjects with colonization of Pseudomonas aeruginosa and a CIPRO MIC of >/=256 µg/ml or mg/l
* Burkholderia cepacia complex colonization of their respiratory tract within the past 12 months (documented by screen laboratory)
* Known aspergillosis (unless asymptomatic). Patients with invasive disease, ABPA with IGE > 500 mg/dL will be excluded
* Transaminase level >3x upper limit of normal (ULN)
* Massive hemoptysis (>/=300 cc or requiring blood transfusion) in the preceding 4 weeks
* Intravenous antibiotic treatment for pulmonary exacerbation in the past 30 days
* Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
* Febrile illness within 1 week before the start of the study
* Active treatment for nontuberculosis mycobacteria
* Exposure to any investigational drug within 30 days
* Any history of allergic reaction to fluoroquinolones or other quinolones
* On oral steroids >20 mg/day for longer than 14 days in the past 3 months
* Creatinine >/=2x ULN
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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 2
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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
1/05/2008
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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
1/01/2011
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Sample size
Target
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Accrual to date
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Final
288
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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Recruitment hospital [1]
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- Brisbane
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Recruitment hospital [2]
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- Chermside
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Recruitment hospital [3]
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- South Brisbane
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Recruitment hospital [4]
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- Adelaide
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Recruitment hospital [5]
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- Clayton
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Recruitment hospital [6]
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- Parkville
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Recruitment hospital [7]
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- Nedlands
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Recruitment postcode(s) [1]
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4029 - Brisbane
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Recruitment postcode(s) [2]
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4032 - Chermside
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment postcode(s) [6]
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3052 - Parkville
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kentucky
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Massachusetts
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Michigan
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Mississippi
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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South Carolina
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Tennessee
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Texas
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Wisconsin
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Copenhagen
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Bayern
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Germany
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Hessen
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Germany
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Sachsen
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Germany
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Berlin
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petach Tikva
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Israel
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Tel Hashomer
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Norway
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Oslo
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Sweden
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Göteborg
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Sweden
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Lund
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Sweden
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Uppsala
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United Kingdom
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Cambridgeshire
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United Kingdom
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Hampshire
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United Kingdom
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North Ireland
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United Kingdom
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State/province [48]
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West Midlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bayer
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Novartis
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
To evaluate the change in forced expiratory volume (FEV1) from baseline to Day 28-30 between Cipro Inhale-treated and placebo-treated subjects after a 4-week treatment period.
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Trial website
https://clinicaltrials.gov/study/NCT00645788
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Trial related presentations / publications
Dorkin HL, Staab D, Operschall E, Alder J, Criollo M. Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis. BMJ Open Respir Res. 2015 Dec 2;2(1):e000100. doi: 10.1136/bmjresp-2015-000100. eCollection 2015.
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Public notes
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Contacts
Principal investigator
Name
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Bayer Study Director
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Address
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Bayer
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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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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00645788
Download to PDF