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OpenTrials
Completed

NCT Number: NCT00319306

Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy

The purpose of this study is to determine whether patients with asthma are better able to manage and control their symptoms by using one inhaler daily that both prevents as well as treats the symptoms of an asthma exacerbation.

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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

Research Site, Fowey, Cornwall, United Kingdom

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged over 18
  • Confirmed diagnosis of mild to moderate asthma by doctor
  • Currently receiving inhaled corticoid-steroid medicine for treatment of asthma and requiring a review of current asthma treatment

Exclusion criteria

  • Women who are pregnant, breast-feeding, or planning pregnancy
  • Patients with a history of chronic obstructive pulmonary disease
  • Patients using any beta blocker therapy
  • Patients receiving steroid tablets or steroid injections

Treatment and study plan

budesonide/formoterol

Drug

Symbicort® Turbohaler®

Device

Primary outcomes

  1. In a real life setting, to compare Symbicort® Single Inhaler Therapy with a patient's previous therapy (including low dose ICS), by assessment of the changes in the Asthma Control Questionnaire score in uncontrolled asthmatic patients.

Secondary outcomes

  1. Change in forced expiratory volume in one second (FEV1)

  2. Change in peak expiratory flow (PEF)

  3. Patient Reported Outcomes: AQLQ(S), SATQ, RCP-3 scores

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: RELEASE

Important dates

Study start
2005
Study completion
2006
First posted
Apr 27, 2006
Registry last updated
Mar 17, 2009

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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