NCT00246935

Brief Summary

The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with chronic obstructive pulmonary disease (COPD) who completed the 24-week evaluation of study APTA-2217-06. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is an extension of the 24-week study APTA-2217-06 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

October 26, 2016

Status Verified

September 1, 2016

Enrollment Period

1.7 years

First QC Date

October 31, 2005

Last Update Submit

October 24, 2016

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPDPhosphodiesterase 4 inhibitorRoflumilast

Outcome Measures

Primary Outcomes (1)

  • Long-term safety after 28 weeks treatment of Roflumilast (total 52 weeks, 24 weeks of study APTA-2217-06 followed by 28 weeks) .

Secondary Outcomes (1)

  • Efficacy.

Interventions

RoflumilastDRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic obstructive pulmonary disease (COPD)
  • Written informed consent
  • Patients who completed the 24-week evaluation of study APTA-2217-06

You may not qualify if:

  • If patients required hospitalization or received emergency care for COPD exacerbation by the investigator (or sub-investigator) between the informed consent day and the starting day
  • Patients with long-term oxygen therapy
  • Serious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nycomed in Japan and Mitsubishi Tanabe Pharma Corporation

Osaka, Japan

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • AstraZeneca AstraZeneca

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2005

First Posted

November 1, 2005

Study Start

May 1, 2005

Primary Completion

January 1, 2007

Study Completion

October 1, 2007

Last Updated

October 26, 2016

Record last verified: 2016-09

Locations

JP(1)