check_circleStudy Completed

Bronchiectasis

Bayer Identifier:

12965

ClinicalTrials.gov Identifier:

NCT00930982

EudraCT Number:

2009-009869-34

EU CT Number:

Not Available
Evaluation of cipro inhale in patients with non-cystic fibrosis bronchiectasis

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - Forced Expiratory Volume 1 < 35% or > 80%
    - Allergic bronchopulmonary aspergillosis
    - Immunodeficiency disease requiring immunoglobulin replacement
    - Inflammatory bowel disease

Trial summary

Enrollment Goal
124
Trial Dates
June 2009 - September 2010
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Ciprofloxacin DPI (BAYQ3939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Krankenhaus GroßhansdorfGroßhansdorf, 22927, Germany
Completed
Johannes-Gutenberg-Universität MainzMainz, 55131, Germany
Completed
IFS Interdisziplinäres FacharztzentrumFrankfurt, 60596, Germany
Completed
Praxis für LungenheilkundeWitten, 58452, Germany
Completed
Gemeinschaftspraxis Drs. Korker, Schmidt & SchaebenKoblenz, 56068, Germany
Terminated
Gemeinschaftspraxis Harald Sudhoff, Drs. med. Thomas Hering,Berlin, 13507, Germany
Completed
IFG Institut für Gesundheitsförderung GmbHRüdersdorf, 15562, Germany
Completed
Freeman HospitalNewcastle Upon Tyne, NE7 7DN, United Kingdom
Completed
Papworth HospitalCambridge, CB3 8RE, United Kingdom
Completed
Bristol Royal InfirmaryBristol, BS2 8HW, United Kingdom
Completed
Norfolk and Norwich University HospitalNorwich, NR4 7UY, United Kingdom
Completed
Central Utah Clinic, PCPayson, 84651, United States
Completed
University of Connecticut Health CenterFarmington, 06030, United States
Completed
Scripps Clinic - Torrey PinesLa Jolla, 92037, United States
Completed
Winthrop-University HospitalMineola, 11501, United States
Completed
Hospital Universitari Son EspasesPalma de Mallorca, 07010, Spain
Completed
Akademiska SjukhusetUppsala, 751 85, Sweden
Completed
Princess Alexandra HospitalWoollongabba, 4102, Australia
Completed
The Alfred HospitalPrahran, 3181, Australia
Completed
Brisbane Mater Misericordiae HospitalSouth Brisbane, 4101, Australia
Completed
Kliniken der Medizinischen Hochschule HannoverHannover, 30625, Germany
Completed
Klinik Löwenstein gGmbHLöwenstein, 74245, Germany
Completed
Zentralklinik Bad Berka GmbHBad Berka, 99437, Germany
Completed
Praxis Drs. Volgmann/WeberHannover, 30167, Germany
Terminated
Praxis Hr. Dr. W. Schröder-BaboGelnhausen, 63571, Germany
Completed
Praxis Hr. Dr. A. de RouxBerlin, 14059, Germany
Completed
Lungenzentrum GeesthachtGeesthacht, 21502, Germany
Completed
Belfast City HospitalBelfast, BT12 7AB, United Kingdom
Completed
University Hospital AintreeLiverpool, L9 7JU, United Kingdom
Terminated
Royal Infirmary of EdinburghEdinburgh, EH16 4SA, United Kingdom
Terminated
University of Arkansas for Medical SciencesLittle Rock, 72205, United States
Completed
Georgetown University HospitalWashington, 20007-2197, United States
Completed
University of Texas Health Center/TylerTyler, 75708-3154, United States
Completed
Naples Institute for Clinical ResearchNaples, 34109-0446, United States
Completed
National Jewish HealthDenver, 80206, United States
Terminated
Medical Chest AssociatesHouston, 77204, United States
Completed
LaPorte County Institute for Clinical Research, Inc.Michigan City, 46360, United States
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Hospital Clínico Universitario de Santiago de CompostelaSantiago de Compostela, 15706, Spain
Completed
Hospital Universitario Infanta Cristina de BadajozBadajoz, 06080, Spain
Completed
Burnside War Memorial HospitalAdelaide, 5065, Australia
Completed
Royal Adelaide HospitalAdelaide, 5000, Australia
Completed
Austin and Repatriation CentreHeidelberg, 3084, Australia
Completed
Concord Repatriation General HospitalConcord, 2139, Australia
Completed
Sir Charles Gairdner HospitalNedlands, 6009, Australia
Completed
Praxis Hr. Dr. L.-H. von VersenBerlin, 10961, Germany
Completed
Praxis Hr. Dr. Th. SchultzBerlin, 12203, Germany

Primary Outcome

  • Change from baseline in total bacterial load in the sputum at end of treatment (Day 29)
    date_rangeTime Frame:
    Baseline and 29 days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change from baseline in forced expiratory volume in 1 second (FEV1)
    date_rangeTime Frame:
    Baseline and up to end of study (planned at Day 84)
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in forced vital capacity (FVC)
    date_rangeTime Frame:
    Baseline and up to end of study (planned at Day 84)
    enhanced_encryption
    Safety Issue:
    No
  • Time to exacerbation with antibiotic intervention
    date_rangeTime Frame:
    Up to end of study (planned at Day 84)
    enhanced_encryption
    Safety Issue:
    No
  • Effect of ciprofloxacin inhale treatment on health-related quality of life (HRQoL) as measured by the Saint George's Respiratory Questionnaire (SGRQ)
    date_rangeTime Frame:
    Up to end of study (planned at Day 84)
    enhanced_encryption
    Safety Issue:
    No
  • Effect of ciprofloxacin inhale treatment on health-related quality of life (HRQoL) as measured by Chronic Respiratory Questionnaire – Self Administered Standardized (CRQ-SAS)
    date_rangeTime Frame:
    Up to end of study (planned at Day 84)
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in high sensitive C-reactive protein (hsCRP)
    date_rangeTime Frame:
    Baseline and up to Day 42
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in absolute neutrophil count (ANC)
    date_rangeTime Frame:
    Baseline and up to Day 42
    enhanced_encryption
    Safety Issue:
    No
  • 24-hour sputum volume
    date_rangeTime Frame:
    Up to end of study (planned at Day 84)
    enhanced_encryption
    Safety Issue:
    No
  • 24-hour sputum color (percentage of participants with non-clear sputum)
    date_rangeTime Frame:
    Up to end of study (planned at Day 84)
    enhanced_encryption
    Safety Issue:
    No
  • Microbiological response of Cipro Inhale per participant
    date_rangeTime Frame:
    Up to end of study (planned at Day 84)
    enhanced_encryption
    Safety Issue:
    No
  • Microbiological response of Cipro Inhale per pathogen
    date_rangeTime Frame:
    Up to end of study (planned at Day 84)
    enhanced_encryption
    Safety Issue:
    No
  • Emergence of new potential respiratory pathogens
    date_rangeTime Frame:
    Up to end of study (planned at Day 84)
    enhanced_encryption
    Safety Issue:
    No
  • Emergence of resistance among baseline pathogens
    date_rangeTime Frame:
    Up to end of study (planned at Day 84)
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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