Clinical trial NCT00930982: Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bronchiectasis
Keywords: Ciprofloxacin
Airway infection
Bronchiectasis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2009-07-02
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29).
timeFrame: Baseline and 29 days
Secondary outcomes:
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline and up to end of study (planned at Day 84)
measure: Change From Baseline in Forced Vital Capacity (FVC)
timeFrame: Baseline and up to end of study (planned at Day 84)
measure: Time to Exacerbation With Antibiotic Intervention
timeFrame: Up to end of study (planned at Day 84)
measure: Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by the Saint George's Respiratory Questionnaire (SGRQ), Total Score
timeFrame: Up to end of study (planned at Day 84)
measure: Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS)
timeFrame: Up to end of study (planned at Day 84)
measure: Change From Baseline in High Sensitive C-reactive Protein (hsCRP)
timeFrame: Baseline and up to Day 42
measure: Change From Baseline in Absolute Neutrophil Count (ANC)
timeFrame: Baseline and up to Day 42
measure: 24-hour Sputum Volume
timeFrame: Up to end of study (planned at Day 84)
measure: 24-hour Sputum Color (Percentage of Participants With Non-clear Sputum)
timeFrame: Up to end of study (planned at Day 84)
measure: Microbiological Response of Cipro Inhale Per Participant
timeFrame: Up to end of study (planned at Day 84)
measure: Microbiological Response of Cipro Inhale Per Pathogen
timeFrame: Up to end of study (planned at Day 84)
measure: Emergence of New Potential Respiratory Pathogens
timeFrame: Up to end of study (planned at Day 84)
measure: Emergence of Resistance Among Baseline Pathogens
timeFrame: Up to end of study (planned at Day 84)
Other outcomes:
measure: Change From Baseline in Total Bacterial Load in the Sputum
timeFrame: Baseline and up to end of study (planned at Day 84)
Locations:
city: Little Rock
country: United States
state: Arkansas
city: La Jolla
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Farmington
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Naples
country: United States
state: Florida
city: Michigan City
country: United States
state: Indiana
city: Mineola
country: United States
state: New York
city: Houston
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Payson
country: United States
state: Utah
city: Concord
country: Australia
state: New South Wales
city: South Brisbane
country: Australia
state: Queensland
city: Woollongabba
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Adelaide
country: Australia
state: South Australia
city: Heidelberg
country: Australia
state: Victoria
city: Prahran
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Löwenstein
country: Germany
state: Baden-Württemberg
city: Rüdersdorf
country: Germany
state: Brandenburg
city: Frankfurt
country: Germany
state: Hessen
city: Gelnhausen
country: Germany
state: Hessen
city: Hannover
country: Germany
state: Niedersachsen
city: Hannover
country: Germany
state: Niedersachsen
city: Witten
country: Germany
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
state: Rheinland-Pfalz
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Geesthacht
country: Germany
state: Schleswig-Holstein
city: Großhansdorf
country: Germany
state: Schleswig-Holstein
city: Bad Berka
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Santiago de Compostela
country: Spain
state: A Coruña
city: Palma de Mallorca
country: Spain
state: Illes Baleares
city: Badajoz
country: Spain
city: Barcelona
country: Spain
city: Uppsala
country: Sweden
city: Bristol
country: United Kingdom
state: Avon
city: Cambridge
country: United Kingdom
state: Cambridgeshire
city: Liverpool
country: United Kingdom
state: Merseyside
city: Belfast
country: United Kingdom
state: North Ireland
city: Newcastle Upon Tyne
country: United Kingdom
state: Tyne and Wear
city: Edinburgh
country: United Kingdom
city: Norwich
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.