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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Budesonide/Formoterol Turbuhaler (Drug); Budesonide Turbuhaler (Pulmicort) (Drug); Terbutaline Turbuhaler (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Symbicort Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

Summary

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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

Secondary outcome:

Immunopathology and remodeling in biopsies

Immunopathology and mediators in induced sputum

Severe asthma exacerbations (number of and time to first)

Forced expiratory volume in 1 second (FEV1)

As-needed use

Safety variables, including adverse events and vital signs

All variables assessed over the 12-month treatment period

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Research Site, Copenhagen, Denmark

Research Site, Ã…lborg, Denmark

Research Site, Ã…rhus C, Denmark

Research Site, Montpellier, France

Research Site, Pessac, France

Research Site, Hannover, Germany

Research Site, Mainz, Germany

Research Site, Marburg, Germany

Research Site, Baraclado, Spain

Research Site, Barcelona No. 40, Spain

Research Site, Barcelona, No. 42, Spain

Research Site, Göteborg, Sweden

Research Site, Lund, Sweden

Research Site, Stockholm, Sweden

Research Site, Umeå, Sweden

Research Site, Uppsala, Sweden

Research Site, Glasgow, United Kingdom

Research Site, Leicester, United Kingdom

Research Site, London, United Kingdom

Research Site, Manchester, United Kingdom

Research Site, Newcastle-Upon-Tyne, United Kingdom

Research Site, Southampton, United Kingdom

Additional Information

Starting date: May 2005
Last updated: January 21, 2011

Page last updated: August 23, 2015

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