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Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00252785
First received: November 11, 2005
Last updated: January 21, 2011
Last verified: January 2011
History of Changes

November 11, 2005
January 21, 2011
October 2005
Not Provided
Morning peak expiratory flow (mPEF)
Same as current
Complete list of historical versions of study NCT00252785 on ClinicalTrials.gov Archive Site
  • Patient reported outcomes regarding disease status (incl. evening PEF), collected via diaries
  • Forced expiratory volume in one second (FEV1)
  • Safety:
  • Adverse events (nature, incidence and severity)
  • Haematology, clinical chemistry and urinalysis
  • 12-lead ECGs, blood pressure, pulse rate
  • - all variables assessed over the 8 week treatment period
Same as current
Not Provided
Not Provided
 
Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients
An 8-week, Randomised, Double Blind, Parallel-group, Multi-centre, Phase III Study Comparing the Efficacy and Safety of Symbicort® Turbuhaler® 160/4.5 µg Twice Daily and Pulmicort® Turbuhaler® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Patients With Asthma

The primary objective of this study is to confirm the efficacy (superiority) of Symbicort® Turbuhaler® 160/4.5 µg twice daily for 8 weeks in comparison to Pulmicort® Turbuhaler® 200 µg twice daily + Theolong® tablet 200 mg twice daily.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
  • Drug: Budesonide/Formoterol
    Other Name: Symbicort
  • Drug: Budesonide
  • Drug: Theophylline
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
340
November 2006
Not Provided

Inclusion Criteria:

  • Diagnosis of asthma with a documented history of at least 6 months duration prior to Visit 1
  • Prescribed daily use of an IGCS for >=12 weeks prior to Visit 1. The dose of IGCS must be 400 to 800 µg/day of Pulmicort® Turbuhaler® or corresponding dose of IGCS. The prescribed dose of IGCS should be constant for at least 4 weeks prior to Visit 1
  • Prescribed daily use of sustained release theophylline for at least 8 weeks prior to Visit 1, or confirmed steady-state blood theophylline concentrations within the effective range (5-15 µg/mL) during 8 weeks prior to Visit 1. The prescribed dose of theophylline should be constant (400 mg/day) for at least 4 weeks prior to Visit 1

Exclusion Criteria:

  • Any significant disease or disorder that may jeopardize the safety of the patient
  • Respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to Visit 1
  • Treatment with oral, parenteral or rectal GCS within 4 weeks prior to Visit 1

Additional inclusion and exclusion criteria will be evaluated by the Investigator
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00252785
D5890C00010
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Symbicort Medical Science Director, MD AstraZeneca
AstraZeneca
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP