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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/NCT00930982
Registration number
NCT00930982
Ethics application status
Date submitted
30/06/2009
Date registered
2/07/2009
Date last updated
12/12/2014
Titles & IDs
Public title
Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis
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Scientific title
Randomized, Placebo-controlled, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Ciprofloxacin Inhale Compared to Placebo in Patients With Non-cystic Fibrosis Bronchiectasis
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Secondary ID [1]
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2009-009869-34
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Secondary ID [2]
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12965
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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 - Ciprofloxacin (Cipro, BAYQ3939)
Treatment: Drugs - Placebo
Experimental: Ciprofloxacin Inhale (BAYQ3939) - 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Placebo Comparator: Placebo - Inhalation of matching placebo twice a day
Treatment: Drugs: Ciprofloxacin (Cipro, BAYQ3939)
Inhalation of 32,5mg Ciprofloxacin inhaled twice a day
Treatment: Drugs: Placebo
Inhalation of matching placebo twice a day
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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 Total Bacterial Load in the Sputum at End of Treatment (Day 29).
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Assessment method [1]
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Total bacterial load was determined in sputum collected before the inhalation of study drug. Sputum samples were either provided by the participant during the respective study visit, or participants had to bring a sputum sample that had been produced within the 4 hours prior to the visit. Induced sputum samples could be collected if the participant was unable to produce a spontaneously expectorated sputum sample of > 2 mL. Imputation method: last observation carried forward (LOCF). CFU: colony forming units, log10: decadic logarithm
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Timepoint [1]
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Baseline and 29 days
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Secondary outcome [1]
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Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
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Assessment method [1]
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Pulmonary function testing (spirometry) was conducted in accordance with American Thoracic Society standards. FEV1 was defined as 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). Imputation method: last observation carried forward (LOCF).
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Timepoint [1]
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Baseline and up to end of study (planned at Day 84)
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Secondary outcome [2]
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Change From Baseline in Forced Vital Capacity (FVC)
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Assessment method [2]
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Pulmonary function testing (spirometry) was conducted in accordance with American Thoracic Society standards. FVC was defined as the maximal volume of air exhaled with maximally forced effort from a maximal inspiration, i.e. vital capacity performed with a maximally forced expiratory effort expressed in liters at BTPS. Imputation method: last observation carried forward (LOCF).
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Timepoint [2]
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Baseline and up to end of study (planned at Day 84)
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Secondary outcome [3]
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Time to Exacerbation With Antibiotic Intervention
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Assessment method [3]
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Acute exacerbation was defined according to the joint American Thoracic Society/European Respiratory Society criteria. For detailed information with regard to this definition of acute exacerbation, please refer to the detailed description in the protocol section. The time to an acute exacerbation with antibiotic intervention was determined.
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Timepoint [3]
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Up to end of study (planned at Day 84)
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Secondary outcome [4]
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Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by the Saint George's Respiratory Questionnaire (SGRQ), Total Score
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Assessment method [4]
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Participants completed the Saint George's Respiratory Questionnaire (SGRQ). They were assured that all data would be treated confidentially and that the answers would not have any influence on study drug treatment. Participants completed the questionnaires on their own in a quiet area, without discussing them with study staff or accompanying persons (e.g. friends or relatives) and before being seen by the clinician. The score ranges from 0 to 100 with 100 being the worst possible score.
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Timepoint [4]
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Up to end of study (planned at Day 84)
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Secondary outcome [5]
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Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS)
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Assessment method [5]
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Participants completed the Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS). They were assured that all data would be treated confidentially and that the answers would not have any influence on study drug treatment. Participants completed the questionnaires on their own in a quiet area, without discussing them with study staff or accompanying persons (e.g. friends or relatives) and before being seen by the clinician. The score ranges between 1 and 7, 1 being the worst possible score.
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Timepoint [5]
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Up to end of study (planned at Day 84)
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Secondary outcome [6]
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Change From Baseline in High Sensitive C-reactive Protein (hsCRP)
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Assessment method [6]
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High sensitive C-reactive protein (hsCRP) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.
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Timepoint [6]
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Baseline and up to Day 42
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Secondary outcome [7]
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Change From Baseline in Absolute Neutrophil Count (ANC)
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Assessment method [7]
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Absolute neutrophil count (ANC) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.
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Timepoint [7]
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Baseline and up to Day 42
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Secondary outcome [8]
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24-hour Sputum Volume
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Assessment method [8]
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Participants were asked to start 24-hour sputum collection samples 24 hours before coming for the respective study visit. The volume of the completed sample was determined.
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Timepoint [8]
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Up to end of study (planned at Day 84)
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Secondary outcome [9]
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24-hour Sputum Color (Percentage of Participants With Non-clear Sputum)
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Assessment method [9]
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Participants were asked to start 24-hour sputum collection samples 24 hours before coming for the respective study visit. Sputum color was assessed as either 'clear', or as 'yellow', 'green' or 'rust', or an assessment of 'no sputum' was made.
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Timepoint [9]
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Up to end of study (planned at Day 84)
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Secondary outcome [10]
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Microbiological Response of Cipro Inhale Per Participant
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Assessment method [10]
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Microbiological response was defined as reduction in bacterial load or eradication (measured as the percentage of participants with positive culture). Missing values were not imputed.
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Timepoint [10]
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Up to end of study (planned at Day 84)
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Secondary outcome [11]
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Microbiological Response of Cipro Inhale Per Pathogen
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Assessment method [11]
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Microbiological response was defined as reduction in bacterial load or eradication (measured as the number of participants with positive culture). Missing values were not imputed. Pathogens analyzed: Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Serratia marcescens, Pseudomonas aeruginosa, mucoid, Pseudomonas aeruginosa, non mucoid, Stenotrophomonas maltophilia, Achromobacter xylosoxydans, Moraxella catarrhalis, Haemophilus influenzae
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Timepoint [11]
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Up to end of study (planned at Day 84)
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Secondary outcome [12]
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Emergence of New Potential Respiratory Pathogens
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Assessment method [12]
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The emergence of new potential respiratory pathogens was evaluated using microbiological analysis. Evaluated was the cumulative number of participants with first appearance of new potential respiratory antigens at each time point. In some cases, participants attended the end of study visit later than Day 84 (up to Day 88).
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Timepoint [12]
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Up to end of study (planned at Day 84)
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Secondary outcome [13]
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Emergence of Resistance Among Baseline Pathogens
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Assessment method [13]
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The emergence of resistance (at least two-fold increase of Minimal inhibitory concentration, MIC, vs. baseline values) probably or possibly related to study medication among baseline pathogens was evaluated using microbiological analysis.
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Timepoint [13]
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Up to end of study (planned at Day 84)
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Eligibility
Key inclusion criteria
- Patients with a proven and documented diagnosis of non-cystic fibrosis idiopathic or
post pneumonic bronchiectasis
- Stable pulmonary status and stable regimen of standard treatment at least for the past
30 days
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Minimum age
18
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
- Forced Expiratory Volume 1 < 35% or > 80%
- Allergic bronchopulmonary aspergillosis
- Immunodeficiency disease requiring immunoglobulin replacement
- Inflammatory bowel disease
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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
1/06/2009
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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
1/09/2010
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Sample size
Target
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Accrual to date
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Final
124
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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- Concord
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Recruitment hospital [2]
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- South Brisbane
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Recruitment hospital [3]
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- Woollongabba
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Recruitment hospital [4]
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- Adelaide
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Recruitment hospital [5]
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- Heidelberg
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Recruitment hospital [6]
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- Prahran
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Recruitment hospital [7]
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- Nedlands
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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4102 - Woollongabba
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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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5065 - Adelaide
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Recruitment postcode(s) [6]
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3084 - Heidelberg
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Recruitment postcode(s) [7]
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3181 - Prahran
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Recruitment postcode(s) [8]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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United States of America
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State/province [2]
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California
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United States of America
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State/province [3]
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Colorado
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Country [4]
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United States of America
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State/province [4]
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Connecticut
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Country [5]
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United States of America
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State/province [5]
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District of Columbia
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Country [6]
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United States of America
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State/province [6]
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Florida
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Country [7]
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United States of America
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State/province [7]
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Indiana
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Country [8]
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United States of America
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State/province [8]
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New York
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Country [9]
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United States of America
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State/province [9]
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Texas
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Country [10]
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United States of America
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State/province [10]
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Utah
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Country [11]
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Germany
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State/province [11]
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Baden-Württemberg
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Country [12]
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Germany
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State/province [12]
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Brandenburg
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Germany
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State/province [13]
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Hessen
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Country [14]
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Germany
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State/province [14]
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Niedersachsen
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Country [15]
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Germany
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State/province [15]
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Schleswig-Holstein
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Germany
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Thüringen
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Germany
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Berlin
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Spain
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A Coruña
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Spain
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State/province [21]
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Illes Baleares
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Spain
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Badajoz
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Spain
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State/province [23]
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Barcelona
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Sweden
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Uppsala
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United Kingdom
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Avon
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United Kingdom
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Cambridgeshire
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United Kingdom
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Merseyside
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United Kingdom
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State/province [28]
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North Ireland
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Country [29]
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United Kingdom
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State/province [29]
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Tyne and Wear
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Country [30]
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United Kingdom
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State/province [30]
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Edinburgh
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Country [31]
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United Kingdom
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State/province [31]
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Norwich
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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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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to find out if bacterial load in the airways can be reduced
after inhalation of ciprofloxacin for 28 days.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00930982
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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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Bayer Study Director
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Address
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Bayer
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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
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00930982
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