NCT00234390

CompletedPhase 4

PreAsthmaControl (PAC)

AstraZeneca Source

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Other study identifiers

Sponsor study identifier

SD-004-0299

Study Type

interventional

Reported enrollment (type unavailable)

400

Locations

1 country

Sites

1

Timeline

Study Start

November 1998

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

December 2004

Actual (reported)

Brief Summary

The purpose of this study is to investigate the ability of budesonide, given during episodes of troublesome lung symptoms to reduce further symptoms in infants and young children at risk of developing asthma

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 400 participants
Study completion date: December 2004
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 1998
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
December 2004
Actual (reported)
First Submitted
October 5, 2005
Actual (reported)
First Posted
October 7, 2005
Actual (reported)

Last Updated: January 24, 2011
Status Verified: January 2011
Last Update Submitted: January 21, 2011

Conditions

Asthma

Outcome Measures

Primary Outcomes (5)

symptom free days
days with no use of bronchodilator
days with no use of bronchodilator and no symptoms
number of treated episodes
number of treatment with add-on medication

Secondary Outcomes (10)

asthma status
time to start of algorithm treatment
the total steroid dose
First treatment episode:
number of symptom days
+5 more secondary outcomes

Interventions

Pulmicort (budesonide) pMDIDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

AgeUp to 6 Months

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Children of asthmatic mothers form the COPSAC birth cohort study

You may not qualify if:

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (1)

Research Site

Copenhagen, Denmark

Related Publications (1)

Bisgaard H, Hermansen MN, Loland L, Halkjaer LB, Buchvald F. Intermittent inhaled corticosteroids in infants with episodic wheezing. N Engl J Med. 2006 May 11;354(19):1998-2005. doi: 10.1056/NEJMoa054692.
PMID: 16687712RESULT

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanes

Study Officials

AstraZeneca AB CNS Medical Science Director, MD
AstraZeneca
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

October 5, 2005

First Posted

October 7, 2005

Study Start

November 1998

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

December 2004

Actual (reported)

NCT00242411

MONO: Symbicort® Single Inhaler Therapy and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults

Phase 4Completed

NCT00272753

Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations

Phase 4Completed

NCT00140946

A Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients (0476-075)

Phase 4Completed

NCT00641472

Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

Phase 4Completed

NCT00641446

Varicella Vaccination With Pulmicort

Phase 4Completed

NCT00238927

Clinical Trial of Fluticasone Versus Placebo at the Onset of a Cold for Children With Asthma

Phase 4Completed

Children born more than 4 weeks preterm

children with other systemic illness that atopy/allergy

Children requiring mechanical ventilation at any time since birth.

Contact the study team to confirm eligibility.

Steroids

Fused-Ring Compounds

Polycyclic Compounds

Last Updated

January 24, 2011

Record last verified: 2011-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00234390
Data provider: ClinicalTrials.gov
Source updated: 2011-01-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:50 UTC

Locations

DK(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (10)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations