NCT02563197

Inhalation Flow Rate-study

An Open, Multi-center Study to Measure Inhaled Flow Rates Generated by Non-CF Bronchiectasis Patients for the T-326 Inhaler

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DEVICE	T-326 Inhaler	No drug dosing,three test inhalations through the inhaler device filled with an empty capsule.

Timeline

• Start date: 2015-11-23
• Primary completion: 2016-02-17
• Completion: 2016-04-29
• First posted: 2015-09-30
• Last updated: 2017-04-26

Locations

10 sites across 1 country: Germany