Inhalation Flow Rate-study

Bayer

Status and phase

Completed

Phase 1

Conditions

Bronchiectasis

Treatments

Device: T-326 Inhaler

Study type

Interventional

Funder types

Industry

Identifiers

NCT02563197

CIV-15-07-013749 (Other Identifier)

17607

Details and patient eligibility

About

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

Full 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).

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.