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Completed

NCT Number: NCT00076076

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ALTANA Pharma, Cities in Russia, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Diagnosis of persistent chronic bronchial asthma
  • Baseline lung function within specified parameters
  • No change in asthma treatment during the last 4 weeks prior to start of baseline period
  • Stable clinical state
  • Except for asthma, in good health
  • Non-smokers or ex-smokers

Main Exclusion Criteria:

  • Poorly controlled asthma
  • Diagnosis of chronic pulmonary disease and/or other relevant lung diseases
  • Patients using continuously (more than 3 days per week) > 8 puffs/day rescue medication

Treatment and study plan

Roflumilast

Drug

Primary outcomes

  1. change in lung function.

Secondary outcomes

  1. change in morning PEF

  2. asthma symptom score

  3. rescue medication

  4. time to withdrawal due to worsening asthma.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

The FLASH Study: A Randomized, Controlled Study of Roflumilast 250 mcg and 500 mcg Versus Placebo in Patients With Asthma

Important dates

Study start
2003
Study completion
2005
First posted
Jan 15, 2004
Registry last updated
Dec 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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