BronchiectasisPhase 2NCT00930982
Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis
A Phase 2 study testing Ciprofloxacin (Cipro, BAYQ3939) in people with Bronchiectasis, run by Bayer at 47 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Ciprofloxacin (Cipro, BAYQ3939)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 47 sitesin 6 countries
- Study dates
- Jun 2009to Sep 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Forced Expiratory Volume 1 < 35% or > 80%
- Allergic bronchopulmonary aspergillosis
- Immunodeficiency disease requiring immunoglobulin replacement
- Inflammatory bowel disease
Trial locations and contacts
47 sites in 6 countries.
47 sites in 6 countries
Germany16 sites
Study site
Bad Berka, Thuringia, 99437
Study site
Berlin, State of Berlin, 10961
Study site
Berlin, State of Berlin, 12203
Study site
Berlin, State of Berlin, 13507
Study site
Berlin, State of Berlin, 14059
Study site
Frankfurt am Main, Hesse, 60596
Study site
Geesthacht, Schleswig-Holstein, 21502
Study site
Gelnhausen, Hesse, 63571
Study site
Großhansdorf, Schleswig-Holstein, 22927
Study site
Hanover, Lower Saxony, 30167
Study site
Hanover, Lower Saxony, 30625
Study site
Koblenz, Rhineland-Palatinate, 56068
Study site
Löwenstein, Baden-Wurttemberg, 74245
Study site
Mainz, Rhineland-Palatinate, 55131
Study site
Rüdersdorf, Brandenburg, 15562
Study site
Witten, North Rhine-Westphalia, 58452
United States11 sites
Study site
Denver, Colorado, 80206
Study site
Farmington, Connecticut, 06030
Study site
Houston, Texas, 77204
Study site
La Jolla, California, 92037
Study site
Little Rock, Arkansas, 72205
Study site
Michigan City, Indiana, 46360
Study site
Mineola, New York, 11501
Study site
Naples, Florida, 34109-0446
Study site
Payson, Utah, 84651
Study site
Tyler, Texas, 75708-3154
Study site
Washington D.C., District of Columbia, 20007-2197
Australia8 sites
Study site
Adelaide, South Australia, 5000
Study site
Adelaide, South Australia, 5065
Study site
Concord, New South Wales, 2139
Study site
Heidelberg, Victoria, 3084
Study site
Nedlands, Western Australia, 6009
Study site
Prahran, Victoria, 3181
Study site
South Brisbane, Queensland, 4101
Study site
Woollongabba, Queensland, 4102
United Kingdom7 sites
Study site
Belfast, North Ireland, BT12 7AB
Study site
Bristol, Avon, BS2 8HW
Study site
Cambridge, Cambridgeshire, CB3 8RE
Study site
Edinburgh, EH16 4SA
Study site
Liverpool, Merseyside, L9 7JU
Study site
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Study site
Norwich, NR4 7UY
Spain4 sites
Study site
Badajoz, Badajoz, 06080
Study site
Barcelona, Barcelona, 08036
Study site
Palma de Mallorca, Illes Baleares, 07010
Study site
Santiago de Compostela, A Coruña, 15706
About this study
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
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.
Read the 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.
- Conditions
- Bronchiectasis
- Being tested
- Ciprofloxacin (Cipro, BAYQ3939), Placebo
- Keywords
- Ciprofloxacin, Airway infection, Bronchiectasis
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin (Cipro, BAYQ3939)Drug
Inhalation of 32,5mg Ciprofloxacin inhaled twice a day
PlaceboDrug
Inhalation of matching placebo twice a day
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin Inhale (BAYQ3939) | Experimental | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily Receives: Drug: Ciprofloxacin (Cipro, BAYQ3939) |
| Placebo | Placebo comparator | Inhalation of matching placebo twice a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 29 days
Secondary outcomes (13)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Pulmonary function testing (spirometry) was conducted in accordance with American Thoracic Society standards. FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). Imputation method: last observation carried forward (LOCF).
Measured: Baseline and up to end of study (planned at Day 84)
Change From Baseline in Forced Vital Capacity (FVC)
Pulmonary function testing (spirometry) was conducted in accordance with American Thoracic Society standards. FVC was defined as the maximal volume of air exhaled with maximally forced effort from a maximal inspiration, i.e. vital capacity performed with a maximally forced expiratory effort expressed in liters at BTPS. Imputation method: last observation carried forward (LOCF).
Measured: Baseline and up to end of study (planned at Day 84)
Time to Exacerbation With Antibiotic Intervention
Acute exacerbation was defined according to the joint American Thoracic Society/European Respiratory Society criteria. For detailed information with regard to this definition of acute exacerbation, please refer to the detailed description in the protocol section. The time to an acute exacerbation with antibiotic intervention was determined.
Measured: 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
Participants completed the Saint George's Respiratory Questionnaire (SGRQ). They were assured that all data would be treated confidentially and that the answers would not have any influence on study drug treatment. Participants completed the questionnaires on their own in a quiet area, without discussing them with study staff or accompanying persons (e.g. friends or relatives) and before being seen by the clinician. The score ranges from 0 to 100 with 100 being the worst possible score.
Measured: 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)
Participants completed the Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS). They were assured that all data would be treated confidentially and that the answers would not have any influence on study drug treatment. Participants completed the questionnaires on their own in a quiet area, without discussing them with study staff or accompanying persons (e.g. friends or relatives) and before being seen by the clinician. The score ranges between 1 and 7, 1 being the worst possible score.
Measured: Up to end of study (planned at Day 84)
Change From Baseline in High Sensitive C-reactive Protein (hsCRP)
High sensitive C-reactive protein (hsCRP) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.
Measured: Baseline and up to Day 42
Change From Baseline in Absolute Neutrophil Count (ANC)
Absolute neutrophil count (ANC) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.
Measured: Baseline and up to Day 42
24-hour Sputum Volume
Participants were asked to start 24-hour sputum collection samples 24 hours before coming for the respective study visit. The volume of the completed sample was determined.
Measured: Up to end of study (planned at Day 84)
24-hour Sputum Color (Percentage of Participants With Non-clear Sputum)
Participants were asked to start 24-hour sputum collection samples 24 hours before coming for the respective study visit. Sputum color was assessed as either 'clear', or as 'yellow', 'green' or 'rust', or an assessment of 'no sputum' was made.
Measured: Up to end of study (planned at Day 84)
Microbiological Response of Cipro Inhale Per Participant
Microbiological response was defined as reduction in bacterial load or eradication (measured as the percentage of participants with positive culture). Missing values were not imputed.
Measured: Up to end of study (planned at Day 84)
Microbiological Response of Cipro Inhale Per Pathogen
Microbiological response was defined as reduction in bacterial load or eradication (measured as the number of participants with positive culture). Missing values were not imputed. Pathogens analyzed: Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Serratia marcescens, Pseudomonas aeruginosa, mucoid, Pseudomonas aeruginosa, non mucoid, Stenotrophomonas maltophilia, Achromobacter xylosoxydans, Moraxella catarrhalis, Haemophilus influenzae
Measured: Up to end of study (planned at Day 84)
Emergence of New Potential Respiratory Pathogens
The emergence of new potential respiratory pathogens was evaluated using microbiological analysis. Evaluated was the cumulative number of participants with first appearance of new potential respiratory antigens at each time point. In some cases, participants attended the end of study visit later than Day 84 (up to Day 88).
Measured: Up to end of study (planned at Day 84)
Emergence of Resistance Among Baseline Pathogens
The emergence of resistance (at least two-fold increase of Minimal inhibitory concentration, MIC, vs. baseline values) probably or possibly related to study medication among baseline pathogens was evaluated using microbiological analysis.
Measured: Up to end of study (planned at Day 84)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930982
- Sponsor's protocol ID
- 12965
- Other IDs
- 2009-009869-34, 2009
- Status last verified
- Nov 2014
- First submitted
- 30 Jun 2009
- Last updated
- 12 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23018904
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00930982
- Acronym / sponsor ID
- 12965
- Conditions
- Bronchiectasis
- Keywords
- Ciprofloxacin, Airway infection, Bronchiectasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Posted 30 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin Inhale (BAYQ3939) | Experimental | Drug: Ciprofloxacin (Cipro, BAYQ3939)32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily |
| Placebo | Placebo comparator | Drug: PlaceboInhalation of matching placebo twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Forced Expiratory Volume 1 < 35% or > 80%
- Allergic bronchopulmonary aspergillosis
- Immunodeficiency disease requiring immunoglobulin replacement
- Inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciprofloxacin (Cipro, BAYQ3939)Inhalation of 32,5mg Ciprofloxacin inhaled twice a day | Drug | Ciprofloxacin Inhale (BAYQ3939) |
| PlaceboInhalation of matching placebo twice a day | Drug | Placebo |
Primary outcome
Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29).
Time frame: Baseline and 29 days
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
13 secondary outcomes
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline and up to end of study (planned at Day 84)
Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Baseline and up to end of study (planned at Day 84)
Time to Exacerbation With Antibiotic Intervention
Time frame: 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
Time frame: 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)
Time frame: Up to end of study (planned at Day 84)
Change From Baseline in High Sensitive C-reactive Protein (hsCRP)
Time frame: Baseline and up to Day 42
Change From Baseline in Absolute Neutrophil Count (ANC)
Time frame: Baseline and up to Day 42
24-hour Sputum Volume
Time frame: Up to end of study (planned at Day 84)
24-hour Sputum Color (Percentage of Participants With Non-clear Sputum)
Time frame: Up to end of study (planned at Day 84)
Microbiological Response of Cipro Inhale Per Participant
Time frame: Up to end of study (planned at Day 84)
Microbiological Response of Cipro Inhale Per Pathogen
Time frame: Up to end of study (planned at Day 84)
Emergence of New Potential Respiratory Pathogens
Time frame: Up to end of study (planned at Day 84)
Emergence of Resistance Among Baseline Pathogens
Time frame: Up to end of study (planned at Day 84)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23018904Wilson 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.
- Click here and search for Bayer products information provided by EMALink provided by the sponsor.
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
47 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ciprofloxacin (Cipro, BAYQ3939) in people with Bronchiectasis, run by Bayer at 47 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Germany, United States, Australia, United Kingdom, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). (time frame: Baseline and 29 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00930982, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2014.