Open-label, safety and efficacy study of Pulmicort® Turbuhaler® in Japanese children with bronchial asthma

Study identifier:D5254C00769

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomized, open-label, parallel-group, 6 week treatment, multi-center, Phase III study to investigate the efficacy and safety of 100ug and 200ug twice daily of Budesonide Turbuhaler® and 50ug and 100umg twice daily of fluticasone Diskus® in Japanese children with bronchial asthma aged 5-15

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

Study drug

budesonide, fluticasone

Sex

All

Actual Enrollment

240

Study type

Interventional

Age

5 Years - 15 Years

Date

Study Start Date: 01 Oct 2006

Primary Completion Date: -

Study Completion Date: 01 Oct 2007

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Provision of signed written informed consent by patient's legal representative; when possible a signed written informed consent should be obtained from the patient themselves
- Patients diagnosed as having bronchial asthma regardless of type of asthma i.e. perennial or seasonal, atopic or non-atopic
- Males/females 5-15 yrs old who are able to experience to inhale with turbuhaler and diskus. the investigator will check whether the patient can inhale appropriately using training devises and "Turbuhaler trainer"
- Patients with bronchial asthma who require treatment with inhaled steroids (patients with drug therapy, in whom asthma is poorly controlled)
- Patients who are already treated with inhaled GCS should have at least 3 months prehistory of asthma before obtaining the written informed consent

Exclusion Criteria

- Use of regular(more than 3 days) systemic (oral, intravenous or intramuscular) steroids within 30 days before the observation period
- The daily dose of inhaled GCS within 30 days before the observation period for the patients who are already treated with inhaled GCS is beyond fluticasone propionate (FP) 200 µg/day or beclomethasone dipropionate (BDP) 200 μg/day.
- Respiratory infections that, in the opinion of the investigator(s), may affect the efficacy evaluation e.g. lower airways infection such as pneumonia, infection with no available effective antimicrobial drugs or with deep seated mycosis within 30 days before the observation period.
- Concurrent serious diseases of liver, kidney, heart or other complications which, in the opinion of the investigator(s), may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study
- Contra-indications (e.g., known or suspected allergy) to budesonide, fluticasone or lactose contained in the investigational product
- Participation in another clinical study within 12 weeks prior to the observation period or during the study
- Previous enrolment in the present study
- Current use of budesonide turbuhaler
- Pregnancy or possible pregnancy, or planning to be pregnant during the study period
- Patients whose legal representative/caregiver is involved in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
- Other subjects who are considered inappropriate to participate in this study as judged by the investigator

No locations available

Arms	Assigned Interventions

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=497&filename=CSR-D5254C00769.pdf
Download
CSR-D5254C00769.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Yoko Ueda

+81-6-6453-7943

[email protected]

Contact Backup

Public Information

+81-6-6453-8011

Investigators

Principal Investigator

Lars-Goran Carlsson

AstraZeneca R&D Lund