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Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bronchiectasis

Intervention: Ciprofloxacin (Cipro, BAYQ3939) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29).

Secondary outcome:

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

Change From Baseline in Forced Vital Capacity (FVC)

Time to Exacerbation With Antibiotic Intervention

Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by the Saint George's Respiratory Questionnaire (SGRQ), Total Score

Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS)

Change From Baseline in High Sensitive C-reactive Protein (hsCRP)

Change From Baseline in Absolute Neutrophil Count (ANC)

24-hour Sputum Volume

24-hour Sputum Color (Percentage of Participants With Non-clear Sputum)

Microbiological Response of Cipro Inhale Per Participant

Microbiological Response of Cipro Inhale Per Pathogen

Emergence of New Potential Respiratory Pathogens

Emergence of Resistance Among Baseline Pathogens

Detailed description: Safety issues are addressed in the AE section. There is no standardised and unanimously accepted definition of exacerbation in COPD; 4 definitions are widely used: (1) using a combination of 3 cardinal symptoms: increased dyspnea, sputum volume, and sputum purulence; (2) looking at the presence of the following patterns of symptoms during >=2 consecutive days: either 2 or more of 3 major symptoms (increase in dyspnoea, sputum volume and sputum purulence); or any 1 major symptom together with any 1 minor symptom (increase in nasal discharge, wheeze, sore throat, cough or fever); (3) a sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD; (4) a complex of respiratory events (i. e. cough, wheezing, dyspnoea or sputum production) lasting >=3 days.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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 Exclusion Criteria:

- Forced Expiratory Volume 1 < 35% or > 80%

- Allergic bronchopulmonary aspergillosis

- Immunodeficiency disease requiring immunoglobulin replacement

- Inflammatory bowel disease

Locations and Contacts

Berlin 14059, Germany

Berlin 12203, Germany

Berlin 13507, Germany

Berlin 10961, Germany

Badajoz 06080, Spain

Barcelona 08036, Spain

Uppsala 751 85, Sweden

Edinburgh EH16 4SA, United Kingdom

Norwich NR4 7UY, United Kingdom

Santiago de Compostela, A Coruña 15706, Spain

Little Rock, Arkansas 72205, United States

Bristol, Avon BS2 8HW, United Kingdom

Löwenstein, Baden-Württemberg 74245, Germany

Rüdersdorf, Brandenburg 15562, Germany

La Jolla, California 92037, United States

Cambridge, Cambridgeshire CB3 8RE, United Kingdom

Denver, Colorado 80206, United States

Farmington, Connecticut 06030, United States

Washington, District of Columbia 20007-2197, United States

Naples, Florida 34109-0446, United States

Frankfurt, Hessen 60596, Germany

Gelnhausen, Hessen 63571, Germany

Palma de Mallorca, Illes Baleares 07010, Spain

Michigan City, Indiana 46360, United States

Liverpool, Merseyside L9 7JU, United Kingdom

Concord, New South Wales 2139, Australia

Mineola, New York 11501, United States

Hannover, Niedersachsen 30167, Germany

Hannover, Niedersachsen 30625, Germany

Witten, Nordrhein-Westfalen 58452, Germany

Belfast, North Ireland BT12 7AB, United Kingdom

South Brisbane, Queensland 4101, Australia

Woollongabba, Queensland 4102, Australia

Koblenz, Rheinland-Pfalz 56068, Germany

Mainz, Rheinland-Pfalz 55131, Germany

Geesthacht, Schleswig-Holstein 21502, Germany

Großhansdorf, Schleswig-Holstein 22927, Germany

Adelaide, South Australia 5065, Australia

Adelaide, South Australia 5000, Australia

Houston, Texas 77204, United States

Tyler, Texas 75708-3154, United States

Bad Berka, Thüringen 99437, Germany

Newcastle Upon Tyne, Tyne and Wear NE7 7DN, United Kingdom

Payson, Utah 84651, United States

Heidelberg, Victoria 3084, Australia

Prahran, Victoria 3181, Australia

Nedlands, Western Australia 6009, Australia

Additional Information

Click here and search for drug information provided by the FDA.

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Starting date: June 2009
Last updated: November 28, 2014

Page last updated: August 23, 2015

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