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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: Budesonide; Drug: Pulmicort Turbuhaler	Phase 3

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. 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)
2. 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)
3. 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)
4. 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)
5. 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)
6. 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)
7. 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)
8. 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)
9. 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)
10. 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)
11. Number of Participants With Adverse Events (AEs) [ Time Frame: 6 weeks ]
    Number of participants with AEs reported during the period on Pulmicort Respules

Eligibility Criteria

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Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Lars-Göran Carlsson, MD	AstraZeneca R&D Lund

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More 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 Posted:	March 5, 2009
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