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

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

Study Overview

• Status: Completed
• Conditions: Bronchiectasis
• Intervention / Treatment: Device: T-326 Inhaler

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).

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T-326; Non Cystic fibrosis bronchiectasis patients will be enrolled for determination of peak inspiratory flow.	Device: T-326 Inhaler; No drug dosing,three test inhalations through the inhaler device filled with an empty capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak inspiratory flow (L/min)	Visit 2 (1-14 days after screening visit 1)

Secondary Outcome Measures

Outcome Measure	Time Frame
Inspiratory volumes (V in L)	Visit 2 (1-14 days after screening visit 1)
Inspiratory time (t in s)	Visit 2 (1-14 days after screening visit 1)

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Novartis

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2015
• Primary Completion (Actual): February 17, 2016
• Study Completion (Actual): April 29, 2016

Study Registration Dates

• First Submitted: September 18, 2015
• First Submitted That Met QC Criteria: September 28, 2015
• First Posted (Estimate): September 30, 2015

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Device study; Peak inspiratory flow rate; Non-cystic fibrosis bronchiectasis; T-326 Inhaler
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: 17607; CIV-15-07-013749 (Other Identifier: EUDAMED No)