NCT00255255

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

Enrollment Period

1.1 years

First QC Date

November 17, 2005

Last Update Submit

January 21, 2011

Conditions

Asthma

Keywords

Asthma

Outcome Measures

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 (3)

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

  • Forced expiratory volume in one second (FEV1)

  • - all variables assessed over the 52 week treatment period

Interventions

Budesonide/FormoterolDRUG
Also known as: Symbicort

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Research Site

Komaki, Aichi-ken, Japan

Location

Research Site

Seto, Aichi-ken, Japan

Location

Research Site

Gifu, Gifu, Japan

Location

Research Site

Ōwa, Gunma, Japan

Location

Research Site

Hiroshima, Hiroshima, Japan

Location

Research Site

Sapporo, Hokkaido, Japan

Location

Research Site

Tomakomai, Hokkaido, Japan

Location

Research Site

Morioka, Iwate, Japan

Location

Research Site

Takamatsu, Kagawa-ken, Japan

Location

Research Site

Kagoshima, Kagoshima-ken, Japan

Location

Research Site

Kochi, Kochi, Japan

Location

Research Site

Beppu, Ohita, Japan

Location

Research Site

Tsukubo-gun, Okayama-ken, Japan

Location

Research Site

Kishiwada, Osaka, Japan

Location

Research Site

Takatsuki, Osaka, Japan

Location

Research Site

Ōta-ku, Tokyo, Japan

Location

Research Site

Shinjuku-ku, Tokyo, Japan

Location

Research Site

Ube, Yamaguchi, Japan

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Formoterol FumarateEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBudesonidePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • AstraZeneca Symbicort Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 17, 2005

First Posted

November 18, 2005

Study Start

November 1, 2005

Primary Completion

December 1, 2006

Study Completion

June 1, 2007

Last Updated

January 24, 2011

Record last verified: 2011-01

Locations

JP(18)