Inhalation Flow Rate-study

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563197
• Other study ID #: 17607
• Secondary ID: CIV-15-07-013749
• Status: Completed
• Phase: Phase 1
• First received: September 18, 2015
• Last updated: April 25, 2017
• Start date: November 23, 2015
• Est. completion date: April 29, 2016

Study information

• Verified date: April 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 29, 2016
• Est. primary completion date: February 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Device:
• T-326 Inhaler
No drug dosing,three test inhalations through the inhaler device filled with an empty capsule.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak inspiratory flow (L/min)		Visit 2 (1-14 days after screening visit 1)
Secondary	Inspiratory volumes (V in L)		Visit 2 (1-14 days after screening visit 1)
Secondary	Inspiratory time (t in s)		Visit 2 (1-14 days after screening visit 1)

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find results for studies related to Bayer products.