PreAsthmaControl (PAC)

NCT ID: NCT00234390

Last Updated: 2011-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-11-30

Study Completion Date

2004-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pulmicort (budesonide) pMDI

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children of asthmatic mothers form the COPSAC birth cohort study

Exclusion Criteria

* Children born more than 4 weeks preterm
* children with other systemic illness that atopy/allergy
* Children requiring mechanical ventilation at any time since birth.
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca AB CNS Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 16687712 (View on PubMed)

Other Identifiers

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SD-004-0299

Identifier Type: -

Identifier Source: org_study_id

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