Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00855959 |
Recruitment Status
:
Completed
First Posted
: March 5, 2009
Results First Posted
: March 11, 2011
Last Update Posted
: March 11, 2011
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: Budesonide Drug: Pulmicort Turbuhaler | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 108 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | February 2009 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | August 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 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
|
Drug: Budesonide
Inhalation powder, inhalation, twice daily, 4 weeks followed by Suspension for nebulisation, inhalation, once or twice daily, 6 weeks
Other Name: Pulmicort
|
Experimental: 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)
|
Drug: Pulmicort Turbuhaler
Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler
|
- Morning Peak Expiratory Flow (mPEF) [ Time Frame: 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)
- Evening Peak Expiratory Flow (ePEF) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 6 weeks ]Number of participants with AEs reported during the period on Pulmicort Respules

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855959
Japan | |
Research Site | |
Ichikawa, Chiba, Japan | |
Research Site | |
Yokosuka, Kanagawa, Japan | |
Research Site | |
Chiyoda, Tokyo, Japan | |
Research City | |
Hino, Tokyo, Japan | |
Research Site | |
Setagaya, Tokyo, Japan | |
Research Site | |
Tachikawa, Tokyo, Japan |
Study Director: | Lars-Göran Carlsson, MD | AstraZeneca R&D Lund |
Responsible Party: | Carlsson, Lars-Goran, MD, Medical Science Director, Est.Respiratory Brands, AstraZeneca Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00855959 History of Changes |
Other Study ID Numbers: |
D5259C00001 |
First Posted: | March 5, 2009 Key Record Dates |
Results First Posted: | March 11, 2011 |
Last Update Posted: | March 11, 2011 |
Last Verified: | February 2011 |
Keywords provided by AstraZeneca:
Asthma Pulmicort Respules |
Additional relevant MeSH terms:
Budesonide Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |