Beta-Blocker in Chronic Obstructive Pulmonary Disease (CO... | NCT00745043

Studies
Beta-Blocker in Chronic Obstructive Pulmonary Disease (COPD) Study

NCT00745043

Sponsor

Waikato Hospital

Status

Completed

Last Update Posted

Jul 29, 2024Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

bronchodilator response

Countries

New Zealand

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

Aug 2008

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

May 2005

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Aug 29, 2008

First Submission Date that Met QC Criteria

Aug 29, 2008

First Posted Date

Sep 1, 2008Estimated

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 25, 2024

Last Update Posted Date

Jul 29, 2024Actual

Name	Class
Waikato Hospital Research Fund	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Smoking causes both smoking related lung disease (COPD) and ischaemic heart disease. These are very common conditions and many patients have both diseases. Beta-blocker drugs are extensively used in the treatment of angina, high blood pressure and after heart attacks to decrease symptoms and prolong life. Beta-agonists are used in COPD to decrease breathlessness and improve exercise tolerance. It used to be thought that beta-blockers cannot be used in COPD patients as they may make the breathlessness worse, but it has now been established that they can be used safely. Beta-blocker drugs and beta-agonists have 'opposite' effects on the body and the investigators do not know if they can work together or if they would cancel each other out. The investigators also do not know which of the different types of beta-blockers now available are better for COPD patients. This study will investigate what happens to the airways of people taking both of these drugs.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
R302	Placebo Comparator	Daily placebo capsules	Drug: bronchodilator response
R303	Active Comparator	Daily metoprolol 95mg capsules	Drug: bronchodilator response
R304	Active Comparator	Daily propranolol 80mg capsules	Drug: bronchodilator response
Open Label	Active Comparator	Daily Metoprolol 190mg capsules	Drug: bronchodilator response

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bronchodilator response	Drug		Open Label R302 R303 R304

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bronchodilator response to salbutamol after beta-blockers		7-10 days
Incremental Shuttle Walk Test Result after taking beta-blockers		7-10 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of COPD
> 40 years of age
> 15 pack year smoking history

Exclusion Criteria:

Contra-indication to beta-blocker use
Severe COPD FEV1 < 30% or 1 L
Not responsive the methacholine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bob Hancox, MD FRACP	Waikato Hospital Research Unit	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Respiratory Medicine		Hamilton	Waikato Region	3204	New Zealand

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