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

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ClinicalTrials.gov Identifier: NCT00855959
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : March 11, 2011
Last Update Posted : March 11, 2011
Sponsor:
Information provided by:
AstraZeneca

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Budesonide
Drug: Pulmicort Turbuhaler
Enrollment 108
Recruitment Details Outpatients, male and female ≥ 16 years with stable asthma
Pre-assignment Details  
Arm/Group Title Pulmicort Turbuhaler and Pulmicort Respules
Hide Arm/Group Description 4 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
Period Title: Overall Study
Started 108
Patients Who Received Pulmicort Respules 105
Completed 99
Not Completed 9
Reason Not Completed
Adverse Event             2
Lost to Follow-up             2
Withdrawal by Subject             3
Pregnancy             1
Incorrect enrolment             1
Arm/Group Title Pulmicort Turbuhaler and Pulmicort Respules
Hide Arm/Group Description 4 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
Overall Number of Baseline Participants 106
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants
43.9  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants
Female
73
  68.9%
Male
33
  31.1%
1.Primary Outcome
Title Morning Peak Expiratory Flow (mPEF)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulmicort Turbuhaler and Pulmicort Respules
Hide Arm/Group Description:
4 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
Overall Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: L/min
3.3  (21.4)
2.Secondary Outcome
Title Evening Peak Expiratory Flow (ePEF)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulmicort Turbuhaler and Pulmicort Respules
Hide Arm/Group Description:
4 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
Overall Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: L/min
3.8  (18.1)
3.Secondary Outcome
Title Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulmicort Turbuhaler and Pulmicort Respules
Hide Arm/Group Description:
4 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
Overall Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.018  (0.198)
4.Secondary Outcome
Title Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulmicort Turbuhaler and Pulmicort Respules
Hide Arm/Group Description:
4 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
Overall Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.022  (0.185)
5.Secondary Outcome
Title Asthma Symptom Score (Total); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulmicort Turbuhaler and Pulmicort Respules
Hide Arm/Group Description:
4 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
Overall Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.039  (0.346)
6.Secondary Outcome
Title Use of Rescue Medication (Daytime)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulmicort Turbuhaler and Pulmicort Respules
Hide Arm/Group Description:
4 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
Overall Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: puffs
0.017  (0.160)
7.Secondary Outcome
Title Use of Rescue Medication (Night-time)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulmicort Turbuhaler and Pulmicort Respules
Hide Arm/Group Description:
4 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
Overall Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: puffs
0.044  (0.220)
8.Secondary Outcome
Title Use of Rescue Medication (Total)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulmicort Turbuhaler and Pulmicort Respules
Hide Arm/Group Description:
4 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
Overall Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: puffs
0.061  (0.317)
9.Secondary Outcome
Title Night-time Awakenings Due to Asthma Symptoms
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulmicort Turbuhaler and Pulmicort Respules
Hide Arm/Group Description:
4 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
Overall Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: awakenings
-0.004  (0.165)
10.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV 1.0)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulmicort Turbuhaler and Pulmicort Respules
Hide Arm/Group Description:
4 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
Overall Number of Participants Analyzed 102
Mean (Standard Deviation)
Unit of Measure: L
0.079  (0.244)
11.Secondary Outcome
Title Forced Vital Capacity (FVC)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulmicort Turbuhaler and Pulmicort Respules
Hide Arm/Group Description:
4 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
Overall Number of Participants Analyzed 102
Mean (Standard Deviation)
Unit of Measure: L
0.105  (0.283)
12.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description Number of participants with AEs reported during the period on Pulmicort Respules
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulmicort Turbuhaler and Pulmicort Respules
Hide Arm/Group Description:
4 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
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Participants
50
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pulmicort Turbuhaler and Pulmicort Respules
Hide Arm/Group Description 4 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
All-Cause Mortality
Pulmicort Turbuhaler and Pulmicort Respules
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pulmicort Turbuhaler and Pulmicort Respules
Affected / at Risk (%)
Total   0/108 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pulmicort Turbuhaler and Pulmicort Respules
Affected / at Risk (%)
Total   7/105 (6.67%) 
Renal and urinary disorders   
Nasopharyngitis  1  7/105 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
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 Submitted: March 4, 2009
First Posted: March 5, 2009
Results First Submitted: August 17, 2010
Results First Posted: March 11, 2011
Last Update Posted: March 11, 2011