NCT00242294

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
570

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2004

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

November 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

October 26, 2016

Status Verified

September 1, 2016

Enrollment Period

1.8 years

First QC Date

October 19, 2005

Last Update Submit

October 24, 2016

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPDPhosphodiesterase 4 inhibitorRoflumilast

Outcome Measures

Primary Outcomes (1)

  • change in lung function parameters (post-bronchodilator).

Secondary Outcomes (1)

  • pulmonary function test, COPD symptoms, rescue medication, evaluation of QOL, COPD exacerbation, adverse events, pharmacokinetics.

Interventions

RoflumilastDRUG

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nycomed Japan and Mitsubishi Tanabe Oharma 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 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2005

First Posted

October 20, 2005

Study Start

November 1, 2004

Primary Completion

September 1, 2006

Study Completion

March 1, 2007

Last Updated

October 26, 2016

Record last verified: 2016-09

Locations

JP(1)