Ba253BINEB Compared to Ba253MDI (Metered Dose Inhaler) in... | NCT02182583

Studies
Ba253BINEB Compared to Ba253MDI (Metered Dose Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02182583

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jul 11, 2014Estimated

Enrollment

163Actual

Phase

Phase 3

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ba253MDI
Ba253BINEB

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1998

Primary Completion Date

Jun 2000Actual

Completion Date

Not provided

First Submitted Date

Jul 2, 2014

First Submission Date that Met QC Criteria

Jul 7, 2014

First Posted Date

Jul 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2014

Last Update Posted Date

Jul 11, 2014Estimated

Description Module

Brief Summary

The objective of this study is to investigate the efficacy and safety of Ba253BINEB during the continuous 4 weeks administration to the patients with COPD using Ba253MDI (Tersigan® aerosol) as the comparator drug.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

163Actual

Label	Type	Description	Intervention Names
Ba253BINEB	Experimental		Drug: Ba253BINEB
Ba253MDI	Active Comparator		Drug: Ba253MDI

Name	Type	Description	Arm Group Labels	Other Names
Ba253MDI	Drug		Ba253MDI	Tersigan® aerosol
Ba253BINEB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in COPD daily symptom scores		Baseline and up to 4 weeks after first drug administration

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in times of cough		Baseline, up to 4 weeks after first drug administration
Change from baseline in peak expiratory flow rate (PEFR)		Baseline, up to 4 weeks after first drug administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria

Patients whose symptoms are stable and have at least 4 symptomatic days a week
Patients with FEV1.0/FVC of <= 70% in the screening test
Patients aged >= 40 years or older
Patients must be able to inhale the study drug via BINEB and MDI
Patients must be able to understand the patient information form

Exclusion Criteria:

Those who correspond to the following shall be excluded from the subjects of study.

Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
Patients who are constantly administered oral steroid
Patients with glaucoma
Patients who have prostatic hypertrophy
Patients with hypersensitivity to anticholinergic drugs or Beta2 agonists.
Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study
Women who are pregnant or who may become pregnant, or nursing women
Patients who are judged by the investigator as inappropriate as the subjects of the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided