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CompletedNCT00242294Updated Oct 26, 2016

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

A Phase 2/3 interventional study of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD), sponsored by AstraZeneca. Completed at 1 site in Japan. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-10-26.

Sponsored by AstraZeneca · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
570
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)

Keywords

  • COPD
  • Phosphodiesterase 4 inhibitor
  • Roflumilast
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 570 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
570 participants

Interventions

  • DrugRoflumilast
06

What researchers measure

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.

07

Study locations

1 site
  • Nycomed Japan and Mitsubishi Tanabe Oharma Corporation
    Osaka, Japan
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00242294
Lead sponsor
AstraZeneca
Collaborators
Mitsubishi Tanabe Pharma Corporation
Responsible party
Sponsor
First posted
Oct 20, 2005
Start date
Nov 2004
Primary completion
Sep 2006
Completion
Mar 2007
Last update
Oct 26, 2016

Study contacts

AstraZeneca AstraZeneca
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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