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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Pulmicort Turbuhaler; Drug: Budesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00855959

D5259C00001

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: Budesonide

2

Experimental group

Description:

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)

Treatment:

Drug: Pulmicort Turbuhaler