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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00930982




Registration number
NCT00930982
Ethics application status
Date submitted
30/06/2009
Date registered
30/06/2009
Date last updated
28/11/2014

Titles & IDs
Public title
Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis
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
Secondary ID [1] 0 0
2009-009869-34
Secondary ID [2] 0 0
12965
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 0 0
Bronchiectasis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ciprofloxacin (Cipro, BAYQ3939)
Treatment: Drugs - Placebo
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

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

Treatment: Drugs: Ciprofloxacin (Cipro, BAYQ3939)
Inhalation of 32,5mg Ciprofloxacin inhaled twice a day

Treatment: Drugs: Placebo
Inhalation of matching placebo twice a day

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). - 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
Timepoint [1] 0 0
Baseline and 29 days
Primary outcome [2] 0 0
Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). - 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
Timepoint [2] 0 0
Baseline and 29 days
Secondary outcome [1] 0 0
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) - 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).
Timepoint [1] 0 0
Baseline and up to end of study (planned at Day 84)
Secondary outcome [2] 0 0
Change From Baseline in Forced Vital Capacity (FVC) - 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).
Timepoint [2] 0 0
Baseline and up to end of study (planned at Day 84)
Secondary outcome [3] 0 0
Time to Exacerbation With Antibiotic Intervention - 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.
Timepoint [3] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [4] 0 0
Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by the Saint George's Respiratory Questionnaire (SGRQ), Total Score - 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.
Timepoint [4] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [5] 0 0
Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS) - 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.
Timepoint [5] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [6] 0 0
Change From Baseline in High Sensitive C-reactive Protein (hsCRP) - High sensitive C-reactive protein (hsCRP) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.
Timepoint [6] 0 0
Baseline and up to Day 42
Secondary outcome [7] 0 0
Change From Baseline in Absolute Neutrophil Count (ANC) - Absolute neutrophil count (ANC) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.
Timepoint [7] 0 0
Baseline and up to Day 42
Secondary outcome [8] 0 0
24-hour Sputum Volume - 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.
Timepoint [8] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [9] 0 0
24-hour Sputum Color (Percentage of Participants With Non-clear Sputum) - 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.
Timepoint [9] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [10] 0 0
Microbiological Response of Cipro Inhale Per Participant - 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.
Timepoint [10] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [11] 0 0
Microbiological Response of Cipro Inhale Per Pathogen - 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
Timepoint [11] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [12] 0 0
Emergence of New Potential Respiratory Pathogens - 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).
Timepoint [12] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [13] 0 0
Emergence of Resistance Among Baseline Pathogens - 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.
Timepoint [13] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [14] 0 0
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) - 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).
Timepoint [14] 0 0
Baseline and up to end of study (planned at Day 84)
Secondary outcome [15] 0 0
Change From Baseline in Forced Vital Capacity (FVC) - 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).
Timepoint [15] 0 0
Baseline and up to end of study (planned at Day 84)
Secondary outcome [16] 0 0
Time to Exacerbation With Antibiotic Intervention - 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.
Timepoint [16] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [17] 0 0
Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by the Saint George's Respiratory Questionnaire (SGRQ), Total Score - 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.
Timepoint [17] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [18] 0 0
Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS) - 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.
Timepoint [18] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [19] 0 0
Change From Baseline in High Sensitive C-reactive Protein (hsCRP) - High sensitive C-reactive protein (hsCRP) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.
Timepoint [19] 0 0
Baseline and up to Day 42
Secondary outcome [20] 0 0
Change From Baseline in Absolute Neutrophil Count (ANC) - Absolute neutrophil count (ANC) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.
Timepoint [20] 0 0
Baseline and up to Day 42
Secondary outcome [21] 0 0
24-hour Sputum Volume - 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.
Timepoint [21] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [22] 0 0
24-hour Sputum Color (Percentage of Participants With Non-clear Sputum) - 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.
Timepoint [22] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [23] 0 0
Microbiological Response of Cipro Inhale Per Participant - 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.
Timepoint [23] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [24] 0 0
Microbiological Response of Cipro Inhale Per Pathogen - 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
Timepoint [24] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [25] 0 0
Emergence of New Potential Respiratory Pathogens - 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).
Timepoint [25] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [26] 0 0
Emergence of Resistance Among Baseline Pathogens - 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.
Timepoint [26] 0 0
Up to end of study (planned at Day 84)

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Forced Expiratory Volume 1 < 35% or > 80%

- Allergic bronchopulmonary aspergillosis

- Immunodeficiency disease requiring immunoglobulin replacement

- Inflammatory bowel disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Concord
Recruitment hospital [2] 0 0
- South Brisbane
Recruitment hospital [3] 0 0
- Woollongabba
Recruitment hospital [4] 0 0
- Adelaide
Recruitment hospital [5] 0 0
- Heidelberg
Recruitment hospital [6] 0 0
- Prahran
Recruitment hospital [7] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
4102 - Woollongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5065 - Adelaide
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3181 - Prahran
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
Germany
State/province [11] 0 0
Baden-Württemberg
Country [12] 0 0
Germany
State/province [12] 0 0
Brandenburg
Country [13] 0 0
Germany
State/province [13] 0 0
Hessen
Country [14] 0 0
Germany
State/province [14] 0 0
Niedersachsen
Country [15] 0 0
Germany
State/province [15] 0 0
Nordrhein-Westfalen
Country [16] 0 0
Germany
State/province [16] 0 0
Rheinland-Pfalz
Country [17] 0 0
Germany
State/province [17] 0 0
Schleswig-Holstein
Country [18] 0 0
Germany
State/province [18] 0 0
Thüringen
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Spain
State/province [20] 0 0
A Coruña
Country [21] 0 0
Spain
State/province [21] 0 0
Illes Baleares
Country [22] 0 0
Spain
State/province [22] 0 0
Badajoz
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Sweden
State/province [24] 0 0
Uppsala
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Avon
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Cambridgeshire
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Merseyside
Country [28] 0 0
United Kingdom
State/province [28] 0 0
North Ireland
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Tyne and Wear
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Edinburgh
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novartis
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Novartis
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00930982
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications