Efficacy and Safety of Roflumilast in Japanese Patients O... | NCT00242294

Studies
Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)

NCT00242294

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Oct 26, 2016Estimated

Enrollment

570

Phase

Phase 2Phase 3

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Roflumilast

Countries

Japan

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 2016

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

Nov 2004

Primary Completion Date

Sep 2006Actual

Completion Date

Mar 2007Actual

First Submitted Date

Oct 19, 2005

First Submission Date that Met QC Criteria

Oct 19, 2005

First Posted Date

Oct 20, 2005Estimated

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

Oct 24, 2016

Last Update Posted Date

Oct 26, 2016Estimated

Name	Class
Tanabe Pharma Corporation	INDUSTRY

Description Module

Brief Summary

The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily. The study duration consists of a baseline period (4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

570

Name	Type	Description	Arm Group Labels	Other Names
Roflumilast	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in lung function parameters (post-bronchodilator).

Secondary Outcomes

Measure	Description	Time Frame
pulmonary function test, COPD symptoms, rescue medication, evaluation of QOL, COPD exacerbation, adverse events, pharmacokinetics.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Main inclusion criteria:

Patients with chronic obstructive pulmonary disease
Current smoker or ex-smoker
30 to 80% of predicted FEV1 after inhalation of short acting beta stimulant

Main exclusion criteria:

Patients with poorly controlled COPD
Patients who need for long-term oxygen therapy
Patients who have concurrent respiratory diseases such as asthma, diffuse panbronchiolitis, congenital sinobronchial syndrome, bronchiolitis obliterans, bronchiectasis, active tuberculosis, pneumoconiosis, pulmonary lymph vascular myoma, which are considered to affect the evaluation

Accepts Healthy Volunteers

Not provided

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AstraZeneca AstraZeneca	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nycomed Japan and Mitsubishi Tanabe Oharma Corporation		Osaka			Japan

Label	URL
APTA-2217-06-RDS-2008-12-05.pdf	View source

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
C424423	Roflumilast

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided