CClinicalTrials.gg
CompletedNCT02563197Updated Apr 26, 2017

Inhalation Flow Rate-study

A Phase 1 interventional study of T-326 Inhaler in Bronchiectasis, sponsored by Bayer. Completed at 10 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-26.

Sponsored by Bayer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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).
02

Conditions studied

  • Bronchiectasis

Browse trials for

Keywords

  • Device study
  • Peak inspiratory flow rate
  • Non-cystic fibrosis bronchiectasis
  • T-326 Inhaler
03

In context

Bronchiectasis

369 studies on the registry are indexed under Bronchiectasis; 105 are open to participants now.

This study's enrollment of 33 is below the median of 60 across 233 interventional studies indexed under Bronchiectasis.

Browse Bronchiectasis studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    T-326

    Non Cystic fibrosis bronchiectasis patients will be enrolled for determination of peak inspiratory flow.

    Device: T-326 Inhaler

Interventions

  • DeviceT-326 Inhaler

    No drug dosing,three test inhalations through the inhaler device filled with an empty capsule.

06

What researchers measure

Primary outcomes

  1. Peak inspiratory flow (L/min)

    Time frame: Visit 2 (1-14 days after screening visit 1)

Secondary outcomes

  1. Inspiratory volumes (V in L)

    Time frame: Visit 2 (1-14 days after screening visit 1)

  2. Inspiratory time (t in s)

    Time frame: Visit 2 (1-14 days after screening visit 1)

07

Study locations

10 sites
  • Gauting, Bayern 82131, Germany
  • Landsberg, Bayern 86899, Germany
  • München, Bayern 80336, Germany
  • München, Bayern 80539, Germany
  • München, Bayern 81241, Germany
  • Frankfurt, Hessen 60389, Germany
  • Frankfurt, Hessen 60596, Germany
  • Neu-Isenburg, Hessen 63263, Germany
  • Hannover, Niedersachsen 30625, Germany
  • Grosshansdorf, 22927, Germany
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02563197
Lead sponsor
Bayer
Collaborators
Novartis
Responsible party
Sponsor
First posted
Sep 30, 2015
Start date
Nov 23, 2015
Primary completion
Feb 17, 2016
Completion
Apr 29, 2016
Last update
Apr 26, 2017

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion