NCT00855959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_3 asthma

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 11, 2011

Completed
Last Updated

March 11, 2011

Status Verified

February 1, 2011

Enrollment Period

6 months

First QC Date

March 4, 2009

Results QC Date

August 17, 2010

Last Update Submit

February 16, 2011

Conditions

Asthma

Keywords

AsthmaPulmicort Respules

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (11)

  • Evening Peak Expiratory Flow (ePEF)

    6 weeks

  • Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)

    6 weeks

  • Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)

    6 weeks

  • Asthma Symptom Score (Total); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)

    6 weeks

  • Use of Rescue Medication (Daytime)

    6 weeks

  • +6 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

Interventions

BudesonideDRUG

Inhalation powder, inhalation, twice daily, 4 weeks followed by Suspension for nebulisation, inhalation, once or twice daily, 6 weeks

Also known as: Pulmicort
1
Pulmicort TurbuhalerDRUG

Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler

2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

Ichikawa, Chiba, Japan

Location

Research Site

Yokosuka, Kanagawa, Japan

Location

Research Site

Chiyoda City, Tokyo, Japan

Location

Research City

Hino, Tokyo, Japan

Location

Research Site

Setagaya City, Tokyo, Japan

Location

Research Site

Tachikawa, Tokyo, Japan

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Lars-Göran Carlsson, MD

    AstraZeneca R&D Lund

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 5, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

March 11, 2011

Results First Posted

March 11, 2011

Record last verified: 2011-02

Locations

JP(6)