NCT01232322

Brief Summary

The purpose of this study is to investigate the safety and efficacy for long term treatment of the drug in children aged 6 months and \< 5 years on bronchial asthma in daily clinical usage.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
633

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

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

October 1, 2006

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

4.8 years

First QC Date

October 31, 2010

Last Update Submit

January 23, 2013

Conditions

Bronchial Asthma

Keywords

bronchial asthmaPulmicort Respuleslong term usepediatrics

Outcome Measures

Primary Outcomes (4)

  • Incidence of Adverse Events

    Range of 3 years

  • Effects on growth rate

    Variation of the height/weight from the baseline.

    Range of 3 years

  • Effects on the adrenal cortical function.

    Symptoms of adrenal cortical function suppression before and after the treatment with Pulmicort.

    Range of 3 years

  • Effects on development of infections.

    Existence and type of infections.

    Range of 3 years

Secondary Outcomes (1)

  • Clinical course under Pulmicort long-term use

Study Arms (1)

Pulmicort Respules

Those with an exposure

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with Pulmicort respules for the first time due to bronchial asthma and children of \>=6months and \<5 years old age at the start of study treatment

You may qualify if:

  • Patients treated with Pulmicort Respules for the first time due to bronchial asthma
  • Children of \>= 6 months and \< 5 years old age at the start of study treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yoshida Shigeru, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2010

First Posted

November 2, 2010

Study Start

October 1, 2006

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

January 24, 2013

Record last verified: 2013-01