Inhalation Flow Rate-study

Phase 1

Completed

• Conditions: Bronchiectasis
• Interventions: Device: T-326 Inhaler

• Registration Number: NCT02563197
• Lead Sponsor: Bayer

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).

Study Timeline

• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Study Start: 2015-11-23
• Primary Completion: 2016-02-17
• Study Completion: 2016-04-29
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
T-326	T-326 Inhaler	Non Cystic fibrosis bronchiectasis patients will be enrolled for determination of peak inspiratory flow.

Primary Outcome Measures

Name	Time	Method
Peak inspiratory flow (L/min)	Visit 2 (1-14 days after screening visit 1)

Secondary Outcome Measures

Name	Time	Method
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)