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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Budesonide; Drug: Pulmicort Turbuhaler

• Registration Number: NCT00855959
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-04
• Study First Submitted QC: 2009-03-04
• Study First Posted: 2009-03-05
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2010-08-17
• Status Verified: 2011-02
• Results First Submitted QC: 2011-02-16
• Last Update Submitted: 2011-02-16
• Results First Posted: 2011-03-11
• Last Update Posted: 2011-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Budesonide	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
2	Pulmicort Turbuhaler	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)

Primary Outcome Measures

Name	Time	Method
Morning Peak Expiratory Flow (mPEF)	6 weeks	Change in morning peak expiratory flow (mPEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)

Secondary Outcome Measures

Name	Time	Method
Evening Peak Expiratory Flow (ePEF)	6 weeks	Change in evening peak expiratory flow (ePEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)	6 weeks	Change in Asthma symptom score (Daytime) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)	6 weeks	Change in Asthma symptom score (Night-time) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Asthma Symptom Score (Total); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)	6 weeks	Change in Asthma symptom score (Total) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Use of Rescue Medication (Daytime)	6 weeks	Change in Use of rescue medication (Daytime) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Use of Rescue Medication (Night-time)	6 weeks	Change in Use of rescue medication (Night-time) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Use of Rescue Medication (Total)	6 weeks	Change in Use of rescue medication (Total) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Night-time Awakenings Due to Asthma Symptoms	6 weeks	Change in Night-time awakenings due to asthma symptoms from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Forced Expiratory Volume in 1 Second (FEV 1.0)	6 weeks	Change in Forced Expiratory Volume in 1 second (FEV 1.0) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Forced Vital Capacity (FVC)	6 weeks	Change in Forced Vital Capacity (FVC) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
Number of Participants With Adverse Events (AEs)	6 weeks	Number of participants with AEs reported during the period on Pulmicort Respules

Trial Locations

Locations (2)

Research Site; 🇯🇵 Tachikawa, Tokyo, Japan

Research City; 🇯🇵 Hino, Tokyo, Japan