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

Condition(s) targeted: Bronchiectasis

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

Phase: Phase 2

Status: Recruiting

Sponsored by: Bayer

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

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

Official title: Randomized, Placebo-controlled, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Ciprofloxacin Inhaled Compared to Placebo in Patients With Non-cystic Fibrosis Bronchiectasis

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in total bacterial load from baseline in the sputum

Secondary outcome:

Time to exacerbation

Change in 24-hour sputum volume and color from baseline

Change from baseline in FEV1 and Forced Vital Capacity

Changes in inflammatory markers

Microbiological response rate of Cipro Inhale

Emergence of new potential respiratory pathogens, and emergence of resistance among baseline pathogens

Questionnaires: SGRQ and CRQ-SAS

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

Criteria:

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

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Badajoz 06080, Spain; Not yet recruiting

Barcelona 08036, Spain; Not yet recruiting

Palma de Mallorca 07014, Spain; Not yet recruiting

Uppsala 751 85, Sweden; Not yet recruiting

Norwich NR4 7UY, United Kingdom; Not yet recruiting

Santiago de Compostela, A Coruña 15706, Spain; Recruiting

Little Rock, Arkansas 72205, United States; Not yet recruiting

Bristol, Avon BS2 8HW, United Kingdom; Not yet recruiting

Löwenstein, Baden-Württemberg 74245, Germany; Not yet recruiting

La Jolla, California 92037, United States; Not yet recruiting

Cambridge, Cambridgeshire CB3 8RE, United Kingdom; Not yet recruiting

Denver, Colorado 80206, United States; Not yet recruiting

Farmington, Connecticut 06030, United States; Not yet recruiting

Washington, District of Columbia 20007-2197, United States; Not yet recruiting

Naples, Florida 34109-0446, United States; Not yet recruiting

Frankfurt, Hessen 60596, Germany; Recruiting

Edinburgh, Lothian EH16 4SA, United Kingdom; Not yet recruiting

Liverpool, Merseyside L9 7JU, United Kingdom; Not yet recruiting

McComb, Mississippi 39648, United States; Not yet recruiting

Sydney, New South Wales 2139, Australia; Not yet recruiting

Mineola, New York 11501-3987, United States; Not yet recruiting

Hannover, Niedersachsen 30625, Germany; Recruiting

Belfast, Northern Ireland BT12 7AB, United Kingdom; Not yet recruiting

Woollongabba, Queensland 4102, Australia; Not yet recruiting

Brisbane, Queensland 4101, Australia; Not yet recruiting

Mainz, Rheinland-Pfalz 55131, Germany; Recruiting

Großhansdorf, Schleswig-Holstein 22927, Germany; Recruiting

Adelaide, South Australia 5065, Australia; Recruiting

Adelaide, South Australia 5000, Australia; Recruiting

Tyler, Texas 75708-3154, United States; Not yet recruiting

Houston, Texas 77204, United States; Not yet recruiting

Bad Berka, Thüringen 99437, Germany; Not yet recruiting

Newcastle Upon Tyne, Tyne and Wear NE7 7DN, United Kingdom; Not yet recruiting

Payson, Utah 84651, United States; Not yet recruiting

Prahran, Victoria 3181, Australia; Not yet recruiting

Heidelberg, Victoria 3084, Australia; Not yet recruiting

Nedlands, Western Australia 6009, Australia; Not yet recruiting

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Starting date: June 2009
Ending date: May 2010
Last updated: October 9, 2009