Long Term safety & efficacy of budesonide inhalation suspension in Japanese children with bronchial asthma

Study identifier:SD-004-0768

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Investigation of safety and efficacy of budesonide inhalation suspension in the long-term use in Japanese children with bronchial asthma (open long-term extension study following study SD-004-0765

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

Pulmicort (budesonide) Respules

Sex

All

Actual Enrollment

54

Study type

Interventional

Age

13 Months - 65 Months

Date

Study Start Date: 01 Jan 2004
Primary Completion Date: 01 Nov 2006
Study Completion Date: 01 Nov 2006

Study design

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

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria