NCT00246922

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 asthma, who completed the 24-week evaluation of study APTA-2217-05. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is the extension of the 24-week study APTA-2217-05 (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 Dec 2004

Typical duration for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
11 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

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

October 31, 2005

Last Update Submit

February 16, 2026

Conditions

Bronchial Asthma

Keywords

AsthmaRoflumilastphosphodiesterase 4 inhibitor

Outcome Measures

Primary Outcomes (1)

  • Long-term safety after 28 weeks treatment of Roflumilast at (total 52 weeks, 24 weeks of study APTA-2217-05 followed by 28 weeks) .

Secondary Outcomes (1)

  • Efficacy.

Interventions

RoflumilastDRUG

Eligibility Criteria

Age20 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with asthma disease
  • Written informed consent
  • Patients who completed the 24-week evaluation of study APTA-2217-05

You may not qualify if:

  • % FEV1.0 \< 60% at both 18 weeks and 24 weeks measurements during APTA-2217-05
  • Patients with poorly controlled asthma between informed consent day and study starting day: need for oral or intravenous steroid therapy, hospitalization or any emergency visit, PEF value worsened for 2 or more consecutive days
  • Serious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nycomed Japan and Mitsubishi Tanabe Pharma Corporation

Osaka, Japan

Location

MeSH Terms

Conditions

Asthma

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

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

December 1, 2004

Primary Completion

January 1, 2007

Study Completion

October 1, 2007

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations

JP(1)