Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-08-31

Brief Summary

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The primary objective of the study is to show similarity of efficacy on Pulmicort Respules 1.0 mg/day or 2.0 mg/day for 6 weeks in the treatment period and the corresponding doses of Pulmicort Turbuhaler 400 μg/day or 800 μg/day for 4 weeks in the observation period in Japanese adult asthmatic patients with age of 16 years or older.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Four weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

Inhalation powder, inhalation, twice daily, 4 weeks followed by Suspension for nebulisation, inhalation, once or twice daily, 6 weeks

2

Pulmicort Turbuhaler at a dose of 200 μg twice daily and Pulmicort Respules at a dose of 0.5 mg twice daily or 1.0 mg once daily (low dose)

Group Type EXPERIMENTAL

Pulmicort Turbuhaler

Intervention Type DRUG

Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler

Interventions

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Budesonide

Inhalation powder, inhalation, twice daily, 4 weeks followed by Suspension for nebulisation, inhalation, once or twice daily, 6 weeks

Intervention Type DRUG

Pulmicort Turbuhaler

Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler

Intervention Type DRUG

Other Intervention Names

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Pulmicort

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study specific procedures.
* A minimum of 6 months documented history of asthma according to the JGL 2006 definition
* Asthma patients under prescribed treatment with ICS at least 3 months before Visit 2.

Exclusion Criteria

* Current or previous tobacco smokers with a history of \>= 10 pack-years
* Use of β-blockers including eye drops
* Clinically significant respiratory infection affecting the asthma, as judged by the investigator(s) within 4 weeks prior to visit 2
* Intake of oral, rectal or parenteral GCS within 4 weeks prior to Visit 2

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No