Can Airflow Limitation in Chronic Obstructive Pulmonary D... | NCT01010178

Studies
Can Airflow Limitation in Chronic Obstructive Pulmonary Disease (COPD) be Reversible by Drugs?

NCT01010178

Sponsor

Baqiyatallah Medical Sciences University

Status

Completed

Last Update Posted

Nov 9, 2009Estimated

Enrollment

64Actual

Phase

Phase 4

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Macrolid, Theophylline, Inhaler Corticosteroids

Countries

Iran

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

Nov 2009

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

Feb 2008

Primary Completion Date

Apr 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Nov 6, 2009

First Submission Date that Met QC Criteria

Nov 6, 2009

First Posted Date

Nov 9, 2009Estimated

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

Nov 6, 2009

Last Update Posted Date

Nov 9, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Macrolid, Theophylline, Corticosteroids	Experimental	Approved drug in this setting	Drug: Macrolid, Theophylline, Inhaler Corticosteroids

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Macrolid, Theophylline, Inhaler Corticosteroids	Drug	we have no permission to include them in detail because of privacy policy of mentioned journal for publication	Macrolid, Theophylline, Corticosteroids

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
15% increasing in forced expiratory volume in 1 second		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

current or past smoker COPD

Exclusion Criteria:

history of significant occupational or other environmental exposures or a connective tissue disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

86 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Center of Chemical Injuries, Baqiyatallah Medical Sciences University, Mollasadra St,		Tehran		19945-546	Iran

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
D013806	Theophylline

Ancestor Terms

ID	Term
D014970	Xanthines
D000470	Alkaloids
D006571	Heterocyclic Compounds
D011688	Purinones

Browse Leaves

Not provided

Browse Branches

Not provided