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OpenTrials
Completed

NCT Number: NCT00255255

Safety & Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With Asthma

This study is to confirm the safety of Symbicort® Turbuhaler® 160/4.5 µg 1, 2 or 4 inhalation b.i.d. over a 52 week treatment period in asthmatic patients who are being treated with IGCS and long acting β2-agonist (LABA) and/or other anti-asthmatic drugs.

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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

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Komaki, Aichi-ken, Japan

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 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
  • Prescribed daily use of at least one of the following:

Theophylline, long acting β2-agonist (LABA), other anti-asthmatic drugs (leucotrine antagonists, inhaled anti-cholinergics, Th2 cytokine inhibitor) for at least 4 weeks prior to Visit 1 at a constant dose

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

Treatment and study plan

budesonide/formoterol

Drug

Other names: Symbicort

Primary outcomes

  1. Safety: Adverse events (nature, incidence and severity) Haematology, clinical chemistry, morning plasma cortisol, urinalysis, and ACTH challenge test 12-lead ECGs, blood pressure, pulse rate

Secondary outcomes

  1. Patient reported outcomes regarding disease status (incl. PEF), collected via diaries

  2. Forced expiratory volume in one second (FEV1)

  3. - all variables assessed over the 52 week treatment period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open, Phase III, Multicentre, 52-week Study, Evaluating the Safety and Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With Asthma

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Nov 18, 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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