Postmarketing Surveillance Study of Berodual® Metered-dos... | NCT02231424

Studies
Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Airways Disease

NCT02231424

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Sep 4, 2014Estimated

Enrollment

713Actual

Phase

Not provided

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Drug: Berodual®

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

Sep 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

Jan 1999

Primary Completion Date

Nov 1999Actual

Completion Date

Not provided

First Submitted Date

Sep 1, 2014

First Submission Date that Met QC Criteria

Sep 1, 2014

First Posted Date

Sep 4, 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

Sep 1, 2014

Last Update Posted Date

Sep 4, 2014Estimated

Description Module

Brief Summary

The aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

713Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
chronic obstructive respiratory tract disease patients			Drug: Drug: Berodual®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drug: Berodual®	Drug		chronic obstructive respiratory tract disease patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall severity of the clinical picture rated on a 4-point scale		after 3 and 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes in dyspnea and/or asthma attacks rated on a 4-point scale		after 3 and 6 weeks
Number of dyspnea episodes rated on a 4-point scale		after 3 and 6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of either sex, including children over 6 years
Chronic obstructive respiratory tract disease. Every doctor was asked to include in this study the first patients coming after each other, who were treated for the first time with Berodual® metered dose inhaler (MDI)

Exclusion Criteria:

Contraindications listed in the Instructions for Use/Summary of Product Characteristics of Berodual® metered-dose inhaler

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with diagnosis of chronic obstructive respiratory tract disease

Sampling Method

Non-Probability Sample

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

Intervention Browse Module

MeSH Terms

ID	Term
C030809	fenoterol, ipratropium drug combination

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided