Inhalation Flow Rate-study

NCT ID: NCT02563197

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-23
• Study Completion Date: 2016-04-29

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).

Conditions

Bronchiectasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

T-326

Non Cystic fibrosis bronchiectasis patients will be enrolled for determination of peak inspiratory flow.

Group Type: EXPERIMENTAL

T-326 Inhaler

Intervention Type: DEVICE

No drug dosing,three test inhalations through the inhaler device filled with an empty capsule.

Interventions

T-326 Inhaler

No drug dosing,three test inhalations through the inhaler device filled with an empty capsule.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Gauting, Bavaria, Germany

Landsberg am Lech, Bavaria, Germany

München, Bavaria, Germany

München, Bavaria, Germany

München, Bavaria, Germany

Frankfurt am Main, Hesse, Germany

Frankfurt am Main, Hesse, Germany

Neu-Isenburg, Hesse, Germany

Hanover, Lower Saxony, Germany

Großhansdorf, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 30848695 (View on PubMed)

Other Identifiers

CIV-15-07-013749

Identifier Type: OTHER

Identifier Source: secondary_id

17607

Identifier Type: -

Identifier Source: org_study_id