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OpenTrials
Completed

NCT Number: NCT00244608

A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®

The purpose of this study is to determine if a flexible dose of Symbicort has a similar effect on the airways of patients with asthma as a higher fixed-dose of Symbicort with additional glucocorticosteroids added.

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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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of asthma for at least 6 months
  • Prescribed daily use of glucocorticosteroids for at least 3 months prior to visit one

Exclusion criteria

  • Respiratory infection affecting asthma within 30 days prior to study
  • Intake of oral, rectal, or parenteral glucocorticosteroids within 30 days prior to study
  • Any significant disease or disorder that may jeopardize the safety of the patient

Treatment and study plan

budesonide/formoterol Turbuhaler

Drug

Other names: Symbicort

Budesonide Turbuhaler (Pulmicort)

Drug

Terbutaline Turbuhaler

Drug

Primary outcomes

  1. Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period)

Secondary outcomes

  1. Immunopathology and remodeling in biopsies

  2. Immunopathology and mediators in induced sputum

  3. Severe asthma exacerbations (number of and time to first)

  4. Forced expiratory volume in 1 second (FEV1)

  5. As-needed use

  6. Safety variables, including adverse events and vital signs

  7. All variables assessed over the 12-month treatment period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Comparison of the Inflammatory Control of Asthma Provided by One Inhalation of Symbicort® Turbuhaler® 160/4.5 µg/Inhalation b.i.d. Plus As-needed Versus One Inhalation of Symbicort® Turbuhaler® 320/9 µg/Inhalation b.i.d. + One Inhalation of Pulmicort® Turbuhaler® 400 µg/Dose b.i.d. Plus Terbutaline Turbuhaler® 0.4 mg/Inhalation As-needed. A 12-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational, Phase IIIB Study in Adult Patients With Asthma, EOS

Important dates

Study start
2005
Study completion
2007
First posted
Oct 27, 2005
Registry last updated
Jan 24, 2011

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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