check_circleStudy Completed

Bronchiectasis

Inhalation Flow Rate-study

Trial purpose

Study should show feasibility of the device for drug delivery into the lung independently of the severity of impaired lung function.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.

  • - 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.

Trial summary

Enrollment Goal
33
Trial Dates
November 2015 - April 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Ciprofloxacin DPI (BAYQ3939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Gauting, 82131, Germany
Completed
Hannover, 30625, Germany
Completed
München, 81241, Germany
Terminated
München, 80336, Germany
Completed
Grosshansdorf, 22927, Germany
Completed
Landsberg, 86899, Germany
Completed
Frankfurt, 60596, Germany
Completed
München, 80539, Germany
Completed
Neu-Isenburg, 63263, Germany
Completed
Frankfurt, 60389, Germany

Primary Outcome

  • Peak inspiratory flow (L/min)
    date_rangeTime Frame:
    Visit 2 (1-14 days after screening visit 1)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Inspiratory volumes (V in L)
    date_rangeTime Frame:
    Visit 2 (1-14 days after screening visit 1)
    enhanced_encryption
    Safety Issue:
    No
  • Inspiratory time (t in s)
    date_rangeTime Frame:
    Visit 2 (1-14 days after screening visit 1)
    enhanced_encryption
    Safety Issue:
    No

Trial design

An open, multi-center study to measure inhaled flow rates generated by non-CF bronchiectasis patients for the T-326 Inhaler
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1