Condition category
Respiratory
Date applied
01/02/2005
Date assigned
23/03/2005
Last edited
15/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thys van der Molen

ORCID ID

Contact details

Dept. General Practice
University Medical Center Groningen
A. Deusinglaan 1
Groningen
9713 AV
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FLU 9705

Study information

Scientific title

Acronym

ASTERISK

Study hypothesis

To compare the efficacy of fluticasone propionate (FP) with placebo (PBO) using daily record card symptoms (shortness of breath, cough, wheezing, rescue medication use).

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Recurrent respiratory symptoms in children

Intervention

6 months treatment with
1. Fluticasone propionate 50 mcg 2 puffs MDI bd via Babyhaler®, or
2. Placebo 2 puffs MDI bd via Babyhaler® and salbutamol 200 mcg MDI via Babyhaler® as rescue medication

Intervention type

Drug

Phase

Not Specified

Drug names

Fluticasone, salbutamol

Primary outcome measures

Symptom score (cough, wheeze, shortness of breath during night and day) as measured by a symptom diary card.

Secondary outcome measures

1. Symptom-free days and nights
2. Use of rescue medication
3. Lung function as measured by the interrupter technique and forced oscillation technique

Overall trial start date

01/01/2001

Overall trial end date

31/08/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 1 to 5 years with recurrent respiratory symptoms for which the GP considered prescribing inhaled corticosteroids
2. During the 2-week run-in period, children are eligible if they have symptoms on at least 7 days

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

96 children (140 were screened, from whom 96 were randomised)

Participant exclusion criteria

1. Use of oral steroids within 8 weeks prior to the study
2. Use of inhaled steroids within 4 weeks prior to the study
3. Other respiratory disease
4. Inability of parents to fill in diaries
5. Incapable of using the inhaler device in a proper way
6. Participation in other trials

Recruitment start date

01/01/2001

Recruitment end date

31/08/2003

Locations

Countries of recruitment

Netherlands

Trial participating centre

Dept. General Practice
Groningen
9713 AV
Netherlands

Sponsor information

Organisation

GlaxoSmithKline (The Netherlands)

Sponsor details

Huis ter Heideweg 62
Zeist
3705 LZ
Netherlands

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

GlaxoSmithKline (The Netherlands) (ref: flu9705)

Alternative name(s)

GlaxoSmithKline Plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Funder name

Stichting Astma Bestrijding (The Netherlands) (ref: 2000/006)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes