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NCT00076076 · ClinicalTrials.gov registry record · Phase 3

The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)

A Phase 3 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
822
Enrollment target

NCT00076076: Completed Phase 3 study, sponsored by AstraZeneca.

NCT00076076 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 822 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00076076, a Phase 3 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
822 participants
Enrollment target

Study Summary

The purpose of this study is to confirm the dose of roflumilast to be used for asthma management by comparing the effects of 250 mcg and 500 mcg oral roflumilast with placebo on pulmonary function and asthma symptoms.

Interventions

  • DRUG Roflumilast

Trial Details

FieldValue
Enrollment Target 822 participants
Start Date 2003-12
Est. Completion 2005-06
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT00076076 record still lists

NCT00076076 is an interventional study that assigns participants to a tested intervention. The registered 822 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which Roflumilast is the first listed.

NCT00076076 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00076076 about?

NCT00076076 is a clinical study titled "The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)". The purpose of this study is to confirm the dose of roflumilast to be used for asthma management by comparing the effects of 250 mcg and 500 mcg oral roflumilast with placebo on pulmonary function and asthma symptoms.

What is the current status of trial NCT00076076?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 822 participants. The study started on 2003-12. Estimated completion is 2005-06.

What interventions are being tested in trial NCT00076076?

The interventions under investigation include: Roflumilast (DRUG).

Who is sponsoring clinical trial NCT00076076?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00076076's enrollment target sits among peer trials

822 402nd of 2000 higher than 1,597 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00076076, the US trial registry maintained by the National Library of Medicine. NCT00076076 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.