Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients - Full Text View

Purpose

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	Intervention	Phase
Asthma	Drug: Budesonide Drug: Pulmicort Turbuhaler	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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)

Resource links provided by NLM:

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Morning Peak Expiratory Flow (mPEF) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Number of participants with AEs reported during the period on Pulmicort Respules


Enrollment:	108
Study Start Date:	February 2009
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855959

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


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
Study First Received:	March 4, 2009
Results First Received:	August 17, 2010
Last Updated:	February 16, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on September 29, 2016