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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide
* Drug: Pulmicort Turbuhaler


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* Inhalation powder, inhalation, twice daily, 4 weeks followed by Suspension for nebulisation, inhalation, once or twice daily, 6 weeks<br>* Other names: Pulmicort;|
| Experimental: 2<br>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<br>* Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 weeks | 
| 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) | 6 weeks | 
| 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) | 6 weeks | 
| 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) | 6 weeks | 
| 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) | 6 weeks | 
| 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) | 6 weeks | 
| 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) | 6 weeks | 
| 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) | 6 weeks | 
| 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) | 6 weeks | 
| 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) | 6 weeks | 
| Number of Participants With Adverse Events (AEs) | Number of participants with AEs reported during the period on Pulmicort Respules | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Pulmicort Respules