Pulmonary Disease, Chronic ObstructivePhase 1NCT01072942
To Evaluate the Safety, Tolerability, Pulmonary Deposition, Pharmacokinetics and Pharmacodynamics of Ciprofloxacin Inhale in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD, GOLD II-III)
A Phase 1 study testing Ciprofloxacin (Cipro InhaIe, BAYQ3939) in people with Pulmonary Disease, Chronic Obstructive, run by Bayer at 1 site in Japan.
Trial summary
The study will be conducted in a single-center, randomized, single-blinded, placebo-controlled, dose escalation design with two dose groups.Multiple-dose inhalation of Ciprofloxacin inhale 50 and 75 mg or placebo will be administered to 16 Japanese patients with COPD in totalPatients with moderate to severe COPD… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Ciprofloxacin (Cipro InhaIe, BAYQ3939)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2010to Jul 2010
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with COPD, 40 to 80 years of age
- All patients must have a diagnosis of COPD and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post-bronchodilator 30% </= Forced Expiratory Volume (FEV1) </= 65% of predicted normal. And a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) <70%.
Who cannot join
- Patients with a significant respiratory disease other than COPD. A significant disease is defined as a disease which, in the opinion of the investigator
- Patients with a medical disorder, condition or history of such that would impair the patients ability to participate or complete this study in the opinion of the investigator, patients who have mental disorder which is inappropriate to communal living in a participation in a clinical study, who have no ability to give informed consent, or who have physical disability
- Patients with a history of CF
- Patients with clinically evident bronchiectasis
- Patients with a history of asthma
- Patients who have undergone thoracotomy with pulmonary resection
- Patients with relevant conspicuous findings in medical history and pre-study examination not related to the underlying disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pulmonary Deposition, Pharmacokinetics and Pharmacodynamics of Ciprofloxacin in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD; GOLD II-III), Following Multiple Inhalation of Ciprofloxacin PulmoSphere Inhalation Powder
The study will be conducted in a single-center, randomized, single-blinded, placebo-controlled, dose escalation design with two dose groups.Multiple-dose inhalation of Ciprofloxacin inhale 50 and 75 mg or placebo will be administered to 16 Japanese patients with COPD in totalPatients with moderate to severe COPD, stage II or III according to GOLD criteria, will participate in the study.The study will consist of 2 steps as indicated below; starting at Step 1 (50 mg) and escalating doses up to Step 2 (75 mg), after the tolerability of the dose in the previous step is confirmed. In each step, the study will be conducted as multiple dose study with b.i.d. regimen for 10 days (between day 2 and 11) in a randomized, single-blind, placebo-controlled design. In addition, before and after the multiple dose administration, single administration will be conducted in each subject (day 0 and 12).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Ciprofloxacin (Cipro InhaIe, BAYQ3939), Placebo
- Keywords
- Chronic Obstructive, Phase I, Pharmacokinetics, Microbiology
- Medical subject headings
- 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 InhaIe, BAYQ3939)Drug
Ciprofloxacin Inhale 50 and 75 mg 2 times a day (BID) for 10 days
PlaceboDrug
Placebo TID for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Ciprofloxacin (Cipro InhaIe, BAYQ3939) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event collection
Measured: Up to 3 weeks
Secondary outcomes (3)
Microbiological examination
Measured: 14 days
Ciprofloxacin concentration in sputum
Measured: 14 days
Ciprofloxacin concentration in plasma
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072942
- Sponsor's protocol ID
- 14019
- Status last verified
- Apr 2014
- First submitted
- 27 Jan 2010
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. 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, Tolerability, Pulmonary Deposition, Pharmacokinetics and Pharmacodynamics of Ciprofloxacin in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD; GOLD II-III), Following Multiple Inhalation of Ciprofloxacin PulmoSphere Inhalation Powder
- ClinicalTrials.gov ID
- NCT01072942
- Acronym / sponsor ID
- 14019
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive, Phase I, Pharmacokinetics, Microbiology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 22 Feb 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.
The study will be conducted in a single-center, randomized, single-blinded, placebo-controlled, dose escalation design with two dose groups.Multiple-dose inhalation of Ciprofloxacin inhale 50 and 75 mg or placebo will be administered to 16 Japanese patients with COPD in totalPatients with moderate to severe COPD, stage II or III according to GOLD criteria, will participate in the study.The study will consist of 2 steps as indicated below; starting at Step 1 (50 mg) and escalating doses up to Step 2 (75 mg), after the tolerability of the dose in the previous step is confirmed. In each step, the study will be conducted as multiple dose study with b.i.d. regimen for 10 days (between day 2 and 11) in a randomized, single-blind, placebo-controlled design. In addition, before and after the multiple dose administration, single administration will be conducted in each subject (day 0 and 12).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Ciprofloxacin (Cipro InhaIe, BAYQ3939) |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with COPD, 40 to 80 years of age
- All patients must have a diagnosis of COPD and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post-bronchodilator 30% </= Forced Expiratory Volume (FEV1) </= 65% of predicted normal. And a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) <70%.
Key exclusion criteria (7 listed)
- Patients with a significant respiratory disease other than COPD. A significant disease is defined as a disease which, in the opinion of the investigator
- Patients with a medical disorder, condition or history of such that would impair the patients ability to participate or complete this study in the opinion of the investigator, patients who have mental disorder which is inappropriate to communal living in a participation in a clinical study, who have no ability to give informed consent, or who have physical disability
- Patients with a history of CF
- Patients with clinically evident bronchiectasis
- Patients with a history of asthma
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 InhaIe, BAYQ3939)Ciprofloxacin Inhale 50 and 75 mg 2 times a day (BID) for 10 days | Drug | Arm 1 |
| PlaceboPlacebo TID for 10 days | Drug | Arm 2 |
Primary outcome
Adverse event collection
Time frame: Up to 3 weeks
3 secondary outcomes
Microbiological examination
Time frame: 14 days
Ciprofloxacin concentration in sputum
Time frame: 14 days
Ciprofloxacin concentration in plasma
Time frame: 14 days
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 2 Apr 2014.
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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 InhaIe, BAYQ3939) in people with Pulmonary Disease, Chronic Obstructive, run by Bayer at 1 site in Japan.
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 7 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 2 Apr 2014. 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 Japan. 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?
Adverse event collection (time frame: Up to 3 weeks). 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 2 Apr 2014.