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

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)”

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• 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
• 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)

Primary Measures

• Morning Peak Expiratory Flow (mPEF)
  • Time Frame: 6 weeks
    Safety Issue?: No

Secondary Measures

• Evening Peak Expiratory Flow (ePEF)
  • Time Frame: 6 weeks
    Safety Issue?: No
• Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
  • Time Frame: 6 weeks
    Safety Issue?: No
• Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
  • Time Frame: 6 weeks
    Safety Issue?: No
• Asthma Symptom Score (Total); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
  • Time Frame: 6 weeks
    Safety Issue?: No
• Use of Rescue Medication (Daytime)
  • Time Frame: 6 weeks
    Safety Issue?: No
• Use of Rescue Medication (Night-time)
  • Time Frame: 6 weeks
    Safety Issue?: No
• Use of Rescue Medication (Total)
  • Time Frame: 6 weeks
    Safety Issue?: No
• Night-time Awakenings Due to Asthma Symptoms
  • Time Frame: 6 weeks
    Safety Issue?: No
• Forced Expiratory Volume in 1 Second (FEV 1.0)
  • Time Frame: 6 weeks
    Safety Issue?: No
• Forced Vital Capacity (FVC)
  • Time Frame: 6 weeks
    Safety Issue?: No
• Number of Participants With Adverse Events (AEs)
  • Time Frame: 6 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00855959

Study ID Number: D5259C00001

ClinicalTrials.gov Identifier: NCT00855959

Health Authority: Japan: Ministry of Health, Labor and Welfare