Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis
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
2 other identifiers
interventional
124
6 countries
47
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2009
Shorter than P25 for phase_2
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 30, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
January 30, 2012
CompletedDecember 12, 2014
November 1, 2014
1.3 years
June 30, 2009
September 19, 2011
November 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline and 29 days
Secondary Outcomes (13)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Baseline and up to end of study (planned at Day 84)
Change From Baseline in Forced Vital Capacity (FVC)
Baseline and up to end of study (planned at Day 84)
Time to Exacerbation With Antibiotic Intervention
Up to end of study (planned at Day 84)
Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by the Saint George's Respiratory Questionnaire (SGRQ), Total Score
Up to end of study (planned at Day 84)
Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS)
Up to end of study (planned at Day 84)
- +8 more secondary outcomes
Other Outcomes (1)
Change From Baseline in Total Bacterial Load in the Sputum
Baseline and up to end of study (planned at Day 84)
Study Arms (2)
Ciprofloxacin Inhale (BAYQ3939)
EXPERIMENTAL32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Placebo
PLACEBO COMPARATORInhalation of matching placebo twice a day
Interventions
Inhalation of 32,5mg Ciprofloxacin inhaled twice a day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Forced Expiratory Volume 1 \< 35% or \> 80%
- Allergic bronchopulmonary aspergillosis
- Immunodeficiency disease requiring immunoglobulin replacement
- Inflammatory bowel disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
La Jolla, California, 92037, United States
Unknown Facility
Denver, Colorado, 80206, United States
Unknown Facility
Farmington, Connecticut, 06030, United States
Unknown Facility
Washington D.C., District of Columbia, 20007-2197, United States
Unknown Facility
Naples, Florida, 34109-0446, United States
Unknown Facility
Michigan City, Indiana, 46360, United States
Unknown Facility
Mineola, New York, 11501, United States
Unknown Facility
Houston, Texas, 77204, United States
Unknown Facility
Tyler, Texas, 75708-3154, United States
Unknown Facility
Payson, Utah, 84651, United States
Unknown Facility
Concord, New South Wales, 2139, Australia
Unknown Facility
South Brisbane, Queensland, 4101, Australia
Unknown Facility
Woollongabba, Queensland, 4102, Australia
Unknown Facility
Adelaide, South Australia, 5000, Australia
Unknown Facility
Adelaide, South Australia, 5065, Australia
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Heidelberg, Victoria, 3084, Australia
Unknown Facility
Prahran, Victoria, 3181, Australia
Unknown Facility
Nedlands, Western Australia, 6009, Australia
Unknown Facility
Löwenstein, Baden-Wurttemberg, 74245, Germany
Unknown Facility
Rüdersdorf, Brandenburg, 15562, Germany
Unknown Facility
Frankfurt am Main, Hesse, 60596, Germany
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Gelnhausen, Hesse, 63571, Germany
Unknown Facility
Hanover, Lower Saxony, 30167, Germany
Unknown Facility
Hanover, Lower Saxony, 30625, Germany
Unknown Facility
Witten, North Rhine-Westphalia, 58452, Germany
Unknown Facility
Koblenz, Rhineland-Palatinate, 56068, Germany
Unknown Facility
Mainz, Rhineland-Palatinate, 55131, Germany
Unknown Facility
Geesthacht, Schleswig-Holstein, 21502, Germany
Unknown Facility
Großhansdorf, Schleswig-Holstein, 22927, Germany
Unknown Facility
Berlin, State of Berlin, 10961, Germany
Unknown Facility
Berlin, State of Berlin, 12203, Germany
Unknown Facility
Berlin, State of Berlin, 13507, Germany
Unknown Facility
Berlin, State of Berlin, 14059, Germany
Unknown Facility
Bad Berka, Thuringia, 99437, Germany
Unknown Facility
Santiago de Compostela, A Coruña, 15706, Spain
Unknown Facility
Badajoz, Badajoz, 06080, Spain
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Barcelona, Barcelona, 08036, Spain
Unknown Facility
Palma de Mallorca, Illes Baleares, 07010, Spain
Unknown Facility
Uppsala, 751 85, Sweden
Unknown Facility
Bristol, Avon, BS2 8HW, United Kingdom
Unknown Facility
Cambridge, Cambridgeshire, CB3 8RE, United Kingdom
Unknown Facility
Liverpool, Merseyside, L9 7JU, United Kingdom
Unknown Facility
Belfast, North Ireland, BT12 7AB, United Kingdom
Unknown Facility
Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom
Unknown Facility
Edinburgh, EH16 4SA, United Kingdom
Unknown Facility
Norwich, NR4 7UY, United Kingdom
Related Publications (1)
Wilson R, Welte T, Polverino E, De Soyza A, Greville H, O'Donnell A, Alder J, Reimnitz P, Hampel B. Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study. Eur Respir J. 2013 May;41(5):1107-15. doi: 10.1183/09031936.00071312. Epub 2012 Sep 27.
PMID: 23018904RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2009
First Posted
July 2, 2009
Study Start
June 1, 2009
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
December 12, 2014
Results First Posted
January 30, 2012
Record last verified: 2014-11