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Completed

NCT Number: NCT00252863

DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in Adults

The purpose of this study is to determine whether Symbicort dosed according to the Symbicort Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment according to the local German treatment guidelines.

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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, Stuttgart, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with asthma, either well-controlled on a regular therapy with a combination of long-acting beta-agonists and inhaled corticosteroids or symptomatic on therapy with inhaled corticosteroids alone.

Exclusion criteria

  • Any other significant lung disease other than asthma
  • Any disease that might put patients at risk if they participate in the study

Treatment and study plan

Symbicort, used twice daily (b.i.d) and as needed (prn)

Drug

Budesonide Turbuhaler 200 µg

Drug

Fluticasone Discus 250 µg

Drug

Formoterol Turbuhaler 4.5 µg

Drug

Terbutaline Turbuhaler 0.5 mg

Drug

Salbutamol pressurized metered dose inhaler (pMDI) 100 µg

Drug

Salmeterol Discus 50 µg

Drug

Budesonide/Formoterol Turbuhaler 160/4.5 µg

Drug

Fluticasone/Salmeterol Discus 250/50 µg

Drug

Fluticasone/Salmeterol Discus 500/50 µg

Drug

Theophylline 200 mg

Drug

Theophylline 300 mg

Drug

Singulair 10 mg

Drug

Primary outcomes

  1. Time to first severe asthma exacerbation

Secondary outcomes

  1. Number of severe asthma exacerbations

  2. Mean use of as-needed medication

  3. Change in forced expiratory volume in 1 second (FEV1) from the end of run-in to the end of the study period

  4. Prescribed asthma medication during the treatment period

  5. Asthma Control Questionnaire (ACQ)

  6. Patient's satisfaction with the treatment question

  7. Health care contacts

  8. Asthma medication

  9. Time lost from paid and unpaid work

  10. Serious adverse events (SAEs)

  11. Discontinuations due to adverse events (AEs)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 µg, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-Week, Randomised, Open-Label, Parallel-Group, Multicentre Study

Important dates

Study start
2004
Study completion
2006
First posted
Nov 15, 2005
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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