search
Back to results

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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Budesonide
Pulmicort Turbuhaler
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Pulmicort Respules

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research City
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm 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

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)

Outcomes

Primary Outcome Measures

Morning Peak Expiratory Flow (mPEF)
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

Evening Peak Expiratory Flow (ePEF)
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)
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)
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)
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)
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)
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)
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
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)
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)
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)
Number of participants with AEs reported during the period on Pulmicort Respules

Full Information

First Posted
March 4, 2009
Last Updated
February 16, 2011
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT00855959
Brief Title
Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients
Official Title
An Evaluation of Efficacy and Safety of Corresponding Doses of Pulmicort Turbuhaler® and Pulmicort Respules® in Japanese Asthmatic Adult Patients (Open, Multicenter, Phase III Study)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Pulmicort Respules

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm 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
Arm Title
2
Arm Type
Experimental
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Budesonide
Other Intervention Name(s)
Pulmicort
Intervention Description
Inhalation powder, inhalation, twice daily, 4 weeks followed by Suspension for nebulisation, inhalation, once or twice daily, 6 weeks
Intervention Type
Drug
Intervention Name(s)
Pulmicort Turbuhaler
Intervention Description
Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler
Primary Outcome Measure Information:
Title
Morning Peak Expiratory Flow (mPEF)
Description
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)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Evening Peak Expiratory Flow (ePEF)
Description
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)
Time Frame
6 weeks
Title
Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
Description
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)
Time Frame
6 weeks
Title
Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
Description
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)
Time Frame
6 weeks
Title
Asthma Symptom Score (Total); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
Description
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)
Time Frame
6 weeks
Title
Use of Rescue Medication (Daytime)
Description
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)
Time Frame
6 weeks
Title
Use of Rescue Medication (Night-time)
Description
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)
Time Frame
6 weeks
Title
Use of Rescue Medication (Total)
Description
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)
Time Frame
6 weeks
Title
Night-time Awakenings Due to Asthma Symptoms
Description
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)
Time Frame
6 weeks
Title
Forced Expiratory Volume in 1 Second (FEV 1.0)
Description
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)
Time Frame
6 weeks
Title
Forced Vital Capacity (FVC)
Description
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)
Time Frame
6 weeks
Title
Number of Participants With Adverse Events (AEs)
Description
Number of participants with AEs reported during the period on Pulmicort Respules
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars-Göran Carlsson, MD
Organizational Affiliation
AstraZeneca R&D Lund
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Ichikawa
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Yokosuka
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Chiyoda
State/Province
Tokyo
Country
Japan
Facility Name
Research City
City
Hino
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Setagaya
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Tachikawa
State/Province
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs