NCT00536913

Brief Summary

The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of steroid potency, improvement of lung function and asthma symptoms in children with asthma (6-11 years).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_3 asthma

Geographic Reach
3 countries

11 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

September 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

February 27, 2012

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

5 months

First QC Date

September 26, 2007

Results QC Date

February 16, 2009

Last Update Submit

April 5, 2012

Conditions

Asthma

Keywords

Symbicort pMDIspacerchildren

Outcome Measures

Primary Outcomes (1)

  • Urinary Free Cortisol (UFC)

    Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment

    At baseline and 4 weeks

Secondary Outcomes (8)

  • Forced Expiratory Volume in 1 Second (FEV1)

    At baseline, at 2 weeks and 4 weeks

  • Morning Peak Expiratory Flow (mPEF)

    Daily during run-in and daily during treatment period of 6 weeks

  • Evening Peak Expiratory Flow (ePEF)

    Daily during run-in and daily during treatment period of 6 weeks

  • Asthma Symptoms at Night

    Daily during run-in and daily during treatment period of 6 weeks

  • Asthma Symptoms at Day

    Daily during run-in and daily during treatment period of 6 weeks

  • +3 more secondary outcomes

Study Arms (2)

With Spacer

EXPERIMENTAL

Budesonide/formoterol pMDI 40/2.25ug + spacer

Drug: Budesonide/formoterol pMDI 40/2.25ug + spacer

Without Spacer

EXPERIMENTAL

Budesonide/formoterol pMDI 40/2.25 ug

Drug: Budesonide/formoterol pMDI 40/2.25 ug

Interventions

Budesonide/formoterol pMDI 40/2.25ug + spacerDRUG
With Spacer
Budesonide/formoterol pMDI 40/2.25 ugDRUG
Without Spacer

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children 6-11 years, diagnosed asthma treated
  • months, PEF
  • % of predicted normal value pre-bronchodilator

You may not qualify if:

  • current systemic glucocorticosteroids usage
  • current respiratory infection
  • any significant disease or disorder as judged by investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Budapest, Hungary

Location

Research Site

Debrecen, Hungary

Location

Research Site

Kaposvár, Hungary

Location

Research Site

Bialystok, Poland

Location

Research Site

Bydgoszcz, Poland

Location

Research Site

Bytom, Poland

Location

Research Site

Karpacz, Poland

Location

Research Site

Krakow, Poland

Location

Research Site

Lodz, Poland

Location

Research Site

Warsaw, Poland

Location

Research Site

Moscow, Russia

Location

MeSH Terms

Conditions

Asthma

Interventions

BudesonideMetered Dose Inhalers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsNebulizers and VaporizersEquipment and Supplies

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Tomas Anderson, MD PhD

    AstraZeneca

    STUDY DIRECTOR

  • Piotr Kuna, MD PhD

    Uniwersytecki Spital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2007

First Posted

September 28, 2007

Study Start

September 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

April 6, 2012

Results First Posted

February 27, 2012

Record last verified: 2012-04

Locations

RU(1)HU(3)PL(7)