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

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ClinicalTrials.gov Identifier: NCT00855959
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : March 11, 2011
Last Update Posted : March 11, 2011
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE March 4, 2009
First Posted Date  ICMJE March 5, 2009
Results First Submitted Date  ICMJE August 17, 2010
Results First Posted Date  ICMJE March 11, 2011
Last Update Posted Date March 11, 2011
Study Start Date  ICMJE February 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2009)
PEF (mPEF) [ Time Frame: Daily ]
Change History Complete list of historical versions of study NCT00855959 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Number of Participants With Adverse Events (AEs) [ Time Frame: 6 weeks ]
    Number of participants with AEs reported during the period on Pulmicort Respules
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2009)
  • PEF (ePEF), Asthma symptom score - day, night and total, Use of rescue medication - day, night and total, Nighttime awakenings due to asthma symptoms [ Time Frame: daily ]
  • Forced expiratory volume in one second (FEV1.0), Forced vital capacity (FVC) [ Time Frame: Visit 2 and 5 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Budesonide
    Inhalation powder, inhalation, twice daily, 4 weeks followed by Suspension for nebulisation, inhalation, once or twice daily, 6 weeks
    Other Name: Pulmicort
  • Drug: Pulmicort Turbuhaler
    Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler
Study Arms  ICMJE
  • 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
    Intervention: Drug: Budesonide
  • 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)
    Intervention: Drug: Pulmicort Turbuhaler
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2011)
108
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2009)
100
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00855959
Other Study ID Numbers  ICMJE D5259C00001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carlsson, Lars-Goran, MD, Medical Science Director, Est.Respiratory Brands, AstraZeneca Pharmaceuticals
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lars-Göran Carlsson, MD AstraZeneca R&D Lund
PRS Account AstraZeneca
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP