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

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