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Trial details imported from ClinicalTrials.gov

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

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
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).
Timepoint [1] 0 0
Baseline and 29 days
Secondary outcome [1] 0 0
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
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)
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
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
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)
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)
Timepoint [6] 0 0
Baseline and up to Day 42
Secondary outcome [7] 0 0
Change From Baseline in Absolute Neutrophil Count (ANC)
Timepoint [7] 0 0
Baseline and up to Day 42
Secondary outcome [8] 0 0
24-hour Sputum Volume
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)
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
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
Timepoint [11] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [12] 0 0
Emergence of New Potential Respiratory Pathogens
Timepoint [12] 0 0
Up to end of study (planned at Day 84)
Secondary outcome [13] 0 0
Emergence of Resistance Among Baseline Pathogens
Timepoint [13] 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
Sex
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
1/06/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2010
Sample size
Target
Accrual to date
Final
124
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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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

TypeCitations or Other Details
Journal Wilson R, Welte T, Polverino E, De Soyza A, Grevil... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00930982