BronchiectasisPhase 1NCT02563197
Inhalation Flow Rate-study
A Phase 1 study testing T-326 Inhaler in people with Bronchiectasis, run by Bayer at 10 sites in Germany.
Trial summary
Study should show feasibility of the device for drug delivery into the lung independently of the severity of impaired lung function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- T-326 Inhaler
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 10 sitesGermany
- Study dates
- 23 Nov 2015to 29 Apr 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of non-cystic fibrosis bronchiectasis, confirmed and documented by high resolution computed tomography (HRCT) or magnetic resonance tomography (MRT)
- Ability to reproducibly perform spirometry according to American Thoracic Society/European Respiratory Society criteria
- Clinically stable in the opinion of the investigator at the time of the study visit.
- Male and female patients ≥ 18 years of age.
Who cannot join
- Pulmonary exacerbation (as judged by the investigator, based on the clinical condition of the subject and taking into account e.g., febrile infection of the lung, relevant decrease in Forced expiratory volume in the first second (FEV1) value, increased sputum production, sputum purulence, recent hospitalization) at study visit or within the preceding six (6) weeks.
- History of lung transplant.
- Recent significant hemoptysis (≥ 300 mL or requiring blood transfusion) in the preceding six (6) weeks before screening.
- Established diagnosis of bronchial asthma.
- Established diagnosis of cystic fibrosis.
- Proof of any relevant medical finding or disease in the last three (3) months which might interfere with participation in the study or patient safety (e.g. pneumothorax, uncontrolled hypertension, uncontrolled cardiac arrhythmia, myocardial infarction, cerebral vascular accident).
Show all 10Show fewer
- A relevant disease that is considered to interfere with the study results is any disease that, except for the impairment of lung function, interferes with the patient's ability to inhale from the device. For example, COPD per se is usually not considered as a reason for patient exclusion, unless coughing or obliteration of the upper airways with sputum interferes with the patient's ability to inhale from the device.
- Relevant surgical history in the last 3 months (e.g., but not limited to abdominal, thoracic, ocular or brain surgery).
- History or evidence of lung resection, thoracotomy, known aneurysm and severe scoliosis.
- Pregnancy.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Study site
Frankfurt am Main, Hesse, 60389
Study site
Frankfurt am Main, Hesse, 60596
Study site
Gauting, Bavaria, 82131
Study site
Großhansdorf, 22927
Study site
Hanover, Lower Saxony, 30625
Study site
Landsberg am Lech, Bavaria, 86899
Study site
München, Bavaria, 80336
Study site
München, Bavaria, 80539
Study site
München, Bavaria, 81241
Study site
Neu-Isenburg, Hesse, 63263
About this study
Official title: An Open, Multi-center Study to Measure Inhaled Flow Rates Generated by Non-CF Bronchiectasis Patients for the T-326 Inhaler
Study should show feasibility of the device for drug delivery into the lung independently of the severity of impaired lung function.
Read the detailed description
The aim of the study is to measure inspiratory profiles of patients with non-Cystic fibrosis bronchiectasis using the breath activated T-326 Inhaler.
The following parameters will be derived from the inspiratory profiles:
- Peak Inspiratory Flow (PIF, in L/min)
- Inspiratory Volume (V, in L)
- Inspiratory Time (t, in s).
- Conditions
- Bronchiectasis
- Being tested
- T-326 Inhaler
- Keywords
- Device study, Peak inspiratory flow rate, Non-cystic fibrosis bronchiectasis, T-326 Inhaler
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-326 InhalerDevice
No drug dosing,three test inhalations through the inhaler device filled with an empty capsule.
| Study group | Role | What they receive |
|---|---|---|
| T-326 | Experimental | Non Cystic fibrosis bronchiectasis patients will be enrolled for determination of peak inspiratory flow. Receives: Device: T-326 Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak inspiratory flow (L/min)
Measured: Visit 2 (1-14 days after screening visit 1)
Secondary outcomes (2)
Inspiratory volumes (V in L)
Measured: Visit 2 (1-14 days after screening visit 1)
Inspiratory time (t in s)
Measured: Visit 2 (1-14 days after screening visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study start23 Nov 2015
- Primary completion17 Feb 2016
- Study completion29 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT02563197
- Sponsor's protocol ID
- 17607
- Other IDs
- CIV-15-07-013749
- Status last verified
- Apr 2017
- First submitted
- 18 Sep 2015
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Stass H, Nagelschmitz J, Kappeler D, Sommerer K, Patzlaff A, Weimann B. Ciprofloxacin Dry Powder for Inhalation: Inspiratory Flow in Patients with Non-cystic Fibrosis Bronchiectasis. J Aerosol Med Pulm Drug Deliv. 2019 Jun;32(3):156-163. doi: 10.1089/jamp.2018.1464. Epub 2019 Mar 8.
PubMed 30848695
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multi-center Study to Measure Inhaled Flow Rates Generated by Non-CF Bronchiectasis Patients for the T-326 Inhaler
- ClinicalTrials.gov ID
- NCT02563197
- Acronym / sponsor ID
- 17607
- Conditions
- Bronchiectasis
- Keywords
- Device study, Peak inspiratory flow rate, Non-cystic fibrosis bronchiectasis, T-326 Inhaler
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- 23 Nov 2015 (actual)
- Primary completion
- 17 Feb 2016 (actual)
- Study completion
- 29 Apr 2016 (actual)
- First posted
- 30 Sep 2015 (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.
Study should show feasibility of the device for drug delivery into the lung independently of the severity of impaired lung function.
Detailed description
The aim of the study is to measure inspiratory profiles of patients with non-Cystic fibrosis bronchiectasis using the breath activated T-326 Inhaler.
The following parameters will be derived from the inspiratory profiles:
- Peak Inspiratory Flow (PIF, in L/min)
- Inspiratory Volume (V, in L)
- Inspiratory Time (t, in s).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T-326 | Experimental | Device: T-326 InhalerNon Cystic fibrosis bronchiectasis patients will be enrolled for determination of peak inspiratory flow. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Established diagnosis of non-cystic fibrosis bronchiectasis, confirmed and documented by high resolution computed tomography (HRCT) or magnetic resonance tomography (MRT)
- Ability to reproducibly perform spirometry according to American Thoracic Society/European Respiratory Society criteria
- Clinically stable in the opinion of the investigator at the time of the study visit.
- Male and female patients ≥ 18 years of age.
Key exclusion criteria (10 listed)
- Pulmonary exacerbation (as judged by the investigator, based on the clinical condition of the subject and taking into account e.g., febrile infection of the lung, relevant decrease in Forced expiratory volume in the first second (FEV1) value, increased sputum production, sputum purulence, recent hospitalization) at study visit or within the preceding six (6) weeks.
- History of lung transplant.
- Recent significant hemoptysis (≥ 300 mL or requiring blood transfusion) in the preceding six (6) weeks before screening.
- Established diagnosis of bronchial asthma.
- Established diagnosis of cystic fibrosis.
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 |
|---|---|---|
| T-326 InhalerNo drug dosing,three test inhalations through the inhaler device filled with an empty capsule. | Device | T-326 |
Primary outcome
Peak inspiratory flow (L/min)
Time frame: Visit 2 (1-14 days after screening visit 1)
2 secondary outcomes
Inspiratory volumes (V in L)
Time frame: Visit 2 (1-14 days after screening visit 1)
Inspiratory time (t in s)
Time frame: Visit 2 (1-14 days after screening visit 1)
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 26 Apr 2017.
- Derived from this study: PubMed 30848695Stass H, Nagelschmitz J, Kappeler D, Sommerer K, Patzlaff A, Weimann B. Ciprofloxacin Dry Powder for Inhalation: Inspiratory Flow in Patients with Non-cystic Fibrosis Bronchiectasis. J Aerosol Med Pulm Drug Deliv. 2019 Jun;32(3):156-163. doi: 10.1089/jamp.2018.1464. Epub 2019 Mar 8.
Related trials for Bronchiectasis
RecruitingPhase 3
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Bronchiectasis, Bronchiectasis Adult
Active, not recruitingObservational study
Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care
Cystic Fibrosis (CF), Non Cystic Fibrosis Bronchiectasis
RecruitingPhase 2
Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingPhase 2
Clairleafᵀᴹ: A Study to Test Long-term Treatment With BI 1291583 in People With Bronchiectasis Who Took Part in a Previous Study With This Medicine
Bronchiectasis
RecruitingPhase 3
The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing T-326 Inhaler in people with Bronchiectasis, run by Bayer at 10 sites 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 4 inclusion and 10 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 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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. 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?
Peak inspiratory flow (L/min) (time frame: Visit 2 (1-14 days after screening visit 1)). 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 NCT02563197, 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 26 Apr 2017; AzTrials last refreshed its copy on 27 Oct 2026.