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New asthma pill shows promise in major trial

NCT ID NCT00242307

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a daily pill called roflumilast (APTA-2217) to see if it improves lung function in adults with asthma. About 450 participants took either the drug or a placebo for 24 weeks. Researchers measured breathing tests, asthma symptoms, and side effects to evaluate safety and effectiveness.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

450 people

The number who actually took part.

Started

May 2004

Finished

Jun 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 70 years

Sex

Anyone

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: * Adult patients with bronchial asthma meeting the Guideline for Prevention and Control of Asthma 2003 (JGL 1998, revised 2nd edition) * No change in asthma treatment during the last 4 weeks prior to the registration * Non-smokers or ex-smokers for 12 months or more * %FEV1 ranging between 60 and 80% Main exclusion criteria: * Patients with poorly controlled asthma * Inhalation therapy exceeding low dose during 4 weeks prior to the registration * Concurrent respiratory diseases such as COPD considered to affect the efficacy evaluation

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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.