BronchiectasisNCT02661438
Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo
A study of Bronchiectasis and Pulmonary Disease, Chronic Obstructive, run by Bayer at 2 sites in United States.
Trial summary
The rationale of this study is to conduct a summative (i.e., validation) usability test of Ciprofloxacin Dry Powder for Inhalation (DPI) and the associated Instructions for Use. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Bronchiectasis, Pulmonary Disease, Chronic Obstructive
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jan 2016to 17 Mar 2016
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects (male and female) with non-cystic fibrosis bronchiectasis (NCFB) or chronic obstructive pulmonary disease (COPD)
- Subjects must be aged ≥40
- Subject must be able to independently manage and administer their NCFB/COPD medications
Who cannot join
- Subjects with recent exacerbation
- Subjects with recent significant hemoptysis in the four weeks before screening (and/or during the screening period)
- Subjects allergic to quinine
- Known chronic bronchial asthma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Jamaica, New York, 11435
Study site
Vero Beach, Florida, 32960
About this study
Official title: Multicenter Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation in Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB) or Chronic Obstructive Pulmonary Disease (COPD) Using Matching Placebo
The rationale of this study is to conduct a summative (i.e., validation) usability test of Ciprofloxacin Dry Powder for Inhalation (DPI) and the associated Instructions for Use.
- Being tested
- Placebo to Ciprofloxacin DPI (BAYQ3939)
- Keywords
- Usability Test
- Medical subject headings
- Bronchiectasis, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo to Ciprofloxacin DPI (BAYQ3939)Drug
Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training
| Study group | Role | What they receive |
|---|---|---|
| Placebo to Ciprofloxacin DPI | Other | Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training Receives: Drug: Placebo to Ciprofloxacin DPI (BAYQ3939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The user performed the inhalation task based on the given instructions properly (Yes/No).
The performance was assessed by a test administrator.
Measured: 1 Day
The user performed the inhalation task safely (Yes/No).
The user safety was assessed by a test administrator.
Measured: 1 Day
DPI (Dry powder for inhalation) device malfunction (Yes/No).
The function was assessed by a test administrator.
Measured: 1 Day
Subject's subjective feedback (paraphrased) on use-safety and usability
Measured: 1 Day
Secondary outcomes (2)
Inhalation time
Inhalation time is assessed with a stop watch.
Measured: 1 Day
User friendliness
User friendliness is assessd by a questionnaire.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study start12 Jan 2016
- Primary completion17 Mar 2016
- Study completion17 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 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
- NCT02661438
- Sponsor's protocol ID
- 18253
- Status last verified
- Dec 2018
- First submitted
- 30 Dec 2015
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation in Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB) or Chronic Obstructive Pulmonary Disease (COPD) Using Matching Placebo
- ClinicalTrials.gov ID
- NCT02661438
- Acronym / sponsor ID
- 18253
- Keywords
- Usability Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 17 Mar 2016 (actual)
- Study completion
- 17 Mar 2016 (actual)
- First posted
- 22 Jan 2016 (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 rationale of this study is to conduct a summative (i.e., validation) usability test of Ciprofloxacin Dry Powder for Inhalation (DPI) and the associated Instructions for Use.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo to Ciprofloxacin DPI | Other | Drug: Placebo to Ciprofloxacin DPI (BAYQ3939)Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects (male and female) with non-cystic fibrosis bronchiectasis (NCFB) or chronic obstructive pulmonary disease (COPD)
- Subjects must be aged ≥40
- Subject must be able to independently manage and administer their NCFB/COPD medications
Key exclusion criteria (4 listed)
- Subjects with recent exacerbation
- Subjects with recent significant hemoptysis in the four weeks before screening (and/or during the screening period)
- Subjects allergic to quinine
- Known chronic bronchial 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 |
|---|---|---|
| Placebo to Ciprofloxacin DPI (BAYQ3939)Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training | Drug | Placebo to Ciprofloxacin DPI |
Primary outcome
The user performed the inhalation task based on the given instructions properly (Yes/No).
Time frame: 1 Day
The performance was assessed by a test administrator.
The user performed the inhalation task safely (Yes/No).
Time frame: 1 Day
The user safety was assessed by a test administrator.
DPI (Dry powder for inhalation) device malfunction (Yes/No).
Time frame: 1 Day
The function was assessed by a test administrator.
Subject's subjective feedback (paraphrased) on use-safety and usability
Time frame: 1 Day
2 secondary outcomes
Inhalation time
Time frame: 1 Day
User friendliness
Time frame: 1 Day
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 19 Dec 2018.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Bronchiectasis and Pulmonary Disease, Chronic Obstructive, run by Bayer at 2 sites in United States.
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 3 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The user performed the inhalation task based on the given instructions properly (Yes/No). (time frame: 1 Day). 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 19 Dec 2018.