Clinical trial NCT02563197: Inhalation Flow Rate-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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bronchiectasis
Keywords: Device study
Peak inspiratory flow rate
Non-cystic fibrosis bronchiectasis
T-326 Inhaler
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2015-09-30
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Peak inspiratory flow (L/min)
timeFrame: Visit 2 (1-14 days after screening visit 1)
Secondary outcomes:
measure: Inspiratory volumes (V in L)
timeFrame: Visit 2 (1-14 days after screening visit 1)
measure: Inspiratory time (t in s)
timeFrame: Visit 2 (1-14 days after screening visit 1)
Other outcomes:
Locations:
city: Gauting
country: Germany
state: Bayern
city: Landsberg
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Frankfurt
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Neu-Isenburg
country: Germany
state: Hessen
city: Hannover
country: Germany
state: Niedersachsen
city: Grosshansdorf
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.