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Asthma drug roflumilast tested for Long-Term safety in new study

NCT ID NCT00246922

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety of the drug roflumilast in adults with asthma. Participants had already finished a 24-week study and took the drug once daily for another 28 weeks. The goal was to see if the drug remained safe over a longer period.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

150 people

Started

Dec 2004

Finished

Oct 2007

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 71 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main inclusion criteria: * Patients with asthma disease * Written informed consent * Patients who completed the 24-week evaluation of study APTA-2217-05 Main exclusion criteria: * % 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

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bronchial asthma

Contacts and locations

Locations

  • Nycomed Japan and Mitsubishi Tanabe Pharma Corporation

    Osaka, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.