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

Asthma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855959
• Other study ID #: D5259C00001
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2009
• Last updated: February 16, 2011
• Start date: February 2009
• Est. completion date: August 2009

Study information

• Verified date: February 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 ß-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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide
Inhalation powder, inhalation, twice daily, 4 weeks followed by Suspension for nebulisation, inhalation, once or twice daily, 6 weeks
• Pulmicort Turbuhaler
Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler

Locations

Country	Name	City	State
Japan	Research Site	Chiyoda	Tokyo
Japan	Research City	Hino	Tokyo
Japan	Research Site	Ichikawa	Chiba
Japan	Research Site	Setagaya	Tokyo
Japan	Research Site	Tachikawa	Tokyo
Japan	Research Site	Yokosuka	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Number of Participants With Adverse Events (AEs)	Number of participants with AEs reported during the period on Pulmicort Respules	6 weeks	No