Disease, PulmonaryPhase 1NCT01052298
Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
A Phase 1 study testing Ciprofloxacin (Cipro inhale, BAYQ3939) in people with Disease, Pulmonary, run by Bayer at 1 site in Germany.
Trial summary
Objectives of the study are to investigate the safety, tolerability and levels of ciprofloxacin in the lung after single and multiple inhalative administration to patients with mild to moderate COPD (stage I-II according to GOLD Criteria). Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Disease, Pulmonary
- What is being tested?
- Ciprofloxacin (Cipro inhale, BAYQ3939)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Sep 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with COPD (Stage I or II according to the GOLD Classification), 35 years of age or older
- Airway obstruction with a post-bronchodilator Forced Expiratory Volume (FEV1) > or equal 50% of predicted normal and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) < 70%.
- Current or ex-smokers with a smoking history of more than 10 pack-years
- Body mass index (BMI) between 18 and 33 kg/m2
- Written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures
Who cannot join
- Significant disease other than COPD as bronchial asthma, cystic fibrosis or clinically evident bronchiectasis
- Total blood eosinophil count >/=600/mm3.
- Thoracotomy with pulmonary resection
- Regular use of daytime oxygen therapy
- Completion of a pulmonary rehabilitation program in the six weeks prior to the pre-study examination or current participation in a rehabilitation program
- Hypersensitivity to the investigational drug or to other quinolones and/or to inactive constituents of the inhalation powder
Show all 16Show fewer
- Hypersensitivity of the bronchial system to inhalation of nebulized drugs or saline solution
- Acute pulmonary exacerbation
- Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
- Concomitant inhalative therapy with antibiotics and/or concomitant systemic therapy with fluoroquinolones
- Oral beta-adrenergics, beta blockers
- Long acting anti-cholinergics within 2 weeks prior to pre-study examination
- Inhaled or oral steroids
- Methylxanthines: 24-hour washout of short-acting theophylline and 48-hour washout of long-acting theophylline prior to pre-study examination
- Antihistamines, antileukotrienes prescribed for asthma
- oral cromolyn sodium or oral nedocromil sodium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety and Tolerability, the Pulmonary Deposition and Pharmacokinetics of Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (GOLD I - II), Following Inhalation of Ciprofloxacin PulmoSphere Inhalation Powder.
Objectives of the study are to investigate the safety, tolerability and levels of ciprofloxacin in the lung after single and multiple inhalative administration to patients with mild to moderate COPD (stage I-II according to GOLD Criteria).
- Conditions
- Disease, Pulmonary
- Being tested
- Ciprofloxacin (Cipro inhale, BAYQ3939), Placebo
- Keywords
- Ciprofloxacin, Inhalation, Pharmacokinetics, Safety, Tolerability, COPD
- Medical subject headings
- Lung Diseases, Respiratory Aspiration, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin (Cipro inhale, BAYQ3939)Drug
32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d.
Ciprofloxacin (Cipro inhale, BAYQ3939)Drug
32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given three times daily (tid) with a concluding single dose on 11d.
Ciprofloxacin (Cipro inhale, BAYQ3939)Drug
48.75 mg ciprofloxacin betaine corresponding to 75 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d.
PlaceboDrug
Placebo inhalation powder will be given as an initial single dose inhalation on 00d.During the multiple dose phase placebo will be given twice/three-times daily with a concluding single dose on day 11d.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Ciprofloxacin (Cipro inhale, BAYQ3939) |
| Arm 2 | Experimental | Not described Receives: Drug: Ciprofloxacin (Cipro inhale, BAYQ3939) |
| Arm 3 | Experimental | Not described Receives: Drug: Ciprofloxacin (Cipro inhale, BAYQ3939) |
| Arm 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs: evaluated by heart rate, blood pressure, clinical laboratory
Measured: Within 28 days after first treatment
Electrocardiogram: evaluated by shape and time intervals
Measured: Within 28 days after first treatment
Pulmonary function test evaluated by FEV1
Measured: Within 28 days after first treatment
Pulse oximetry by peripheral oxygen concentration
Measured: Within 12 days after first treatment
Secondary outcomes (4)
Determination of ciprofloxacin concentration in blood
Measured: Within 14 days after first treatment
Determination of ciprofloxacin concentration in urine
Measured: Within 14 days after first treatment
Determination of ciprofloxacin concentration in sputum
Measured: Within 14 days after first treatment
Determination of ciprofloxacin concentration in oral rinsing fluid
Measured: Within 7 days after first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startApr 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease, PulmonaryStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052298
- Sponsor's protocol ID
- 13013
- Other IDs
- 2008-006770-14, 2008
- Status last verified
- May 2013
- First submitted
- 15 Oct 2009
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety and Tolerability, the Pulmonary Deposition and Pharmacokinetics of Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (GOLD I - II), Following Inhalation of Ciprofloxacin PulmoSphere Inhalation Powder.
- ClinicalTrials.gov ID
- NCT01052298
- Acronym / sponsor ID
- 13013
- Conditions
- Disease, Pulmonary
- Keywords
- Ciprofloxacin, Inhalation, Pharmacokinetics, Safety, Tolerability, COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- Apr 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives of the study are to investigate the safety, tolerability and levels of ciprofloxacin in the lung after single and multiple inhalative administration to patients with mild to moderate COPD (stage I-II according to GOLD Criteria).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Ciprofloxacin (Cipro inhale, BAYQ3939) |
| Arm 2 | Experimental | Drug: Ciprofloxacin (Cipro inhale, BAYQ3939) |
| Arm 3 | Experimental | Drug: Ciprofloxacin (Cipro inhale, BAYQ3939) |
| Arm 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients with COPD (Stage I or II according to the GOLD Classification), 35 years of age or older
- Airway obstruction with a post-bronchodilator Forced Expiratory Volume (FEV1) > or equal 50% of predicted normal and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) < 70%.
- Current or ex-smokers with a smoking history of more than 10 pack-years
- Body mass index (BMI) between 18 and 33 kg/m2
- Written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures
Key exclusion criteria (16 listed)
- Significant disease other than COPD as bronchial asthma, cystic fibrosis or clinically evident bronchiectasis
- Total blood eosinophil count >/=600/mm3.
- Thoracotomy with pulmonary resection
- Regular use of daytime oxygen therapy
- Completion of a pulmonary rehabilitation program in the six weeks prior to the pre-study examination or current participation in a rehabilitation program
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 inhale, BAYQ3939)32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d. | Drug | Arm 1 |
| Ciprofloxacin (Cipro inhale, BAYQ3939)32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given three times daily (tid) with a concluding single dose on 11d. | Drug | Arm 2 |
| Ciprofloxacin (Cipro inhale, BAYQ3939)48.75 mg ciprofloxacin betaine corresponding to 75 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d. | Drug | Arm 3 |
| PlaceboPlacebo inhalation powder will be given as an initial single dose inhalation on 00d.During the multiple dose phase placebo will be given twice/three-times daily with a concluding single dose on day 11d. | Drug | Arm 4 |
Primary outcome
Vital signs: evaluated by heart rate, blood pressure, clinical laboratory
Time frame: Within 28 days after first treatment
Electrocardiogram: evaluated by shape and time intervals
Time frame: Within 28 days after first treatment
Pulmonary function test evaluated by FEV1
Time frame: Within 28 days after first treatment
Pulse oximetry by peripheral oxygen concentration
Time frame: Within 12 days after first treatment
4 secondary outcomes
Determination of ciprofloxacin concentration in blood
Time frame: Within 14 days after first treatment
Determination of ciprofloxacin concentration in urine
Time frame: Within 14 days after first treatment
Determination of ciprofloxacin concentration in sputum
Time frame: Within 14 days after first treatment
Determination of ciprofloxacin concentration in oral rinsing fluid
Time frame: Within 7 days after first treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ciprofloxacin (Cipro inhale, BAYQ3939) in people with Disease, Pulmonary, run by Bayer at 1 site in Germany.
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 5 inclusion and 16 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 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vital signs: evaluated by heart rate, blood pressure, clinical laboratory (time frame: Within 28 days after first treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2013.