Condition category
Respiratory
Date applied
11/03/2005
Date assigned
22/03/2005
Last edited
18/02/2008
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

Dr Saad Alotaibi

ORCID ID

Contact details

P.O. Box 951
Ardeyah City
92400
Kuwait
saalotai@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16027

Study information

Scientific title

Acronym

Study hypothesis

The aim of the study is to study the effect of inhaled steroids on school-aged children with chronic lung disease (CLD). The study hypothesis is that inhaled corticosteroids, Beclomethasone Dipropionate will improve respiratory system resistance after 6 weeks of treatment.

Ethics approval

This study was approved by the conjoint Health Research Ethics Board and Child Health Research Committee at the University of Calgary, Alberta (Canada).

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

Chronic lung disease of infancy or bronchopulmonary dysplasia

Intervention

Children will receive inhaled corticosteroids or placebo for 6 weeks, pulmonary function either forced expiratory volume in 1 second (FEV1) or impulse oscillometry and quality of life will be assessed before and after the intervention.

Intervention type

Drug

Phase

Not Specified

Drug names

Beclomethasone Dipropionate

Primary outcome measures

Improvement in respiratory system resistance at 5 Hz frequency using impulse oscillometry after 6 weeks of inhaled corticosteroids in CLD.

Secondary outcome measures

Improvement in quality of life system score using Child Health Questionnaire (CHQ) and FEV1 response to bronchodilators (Salbutamol) after inhaled corticosteroids treatment for 6 weeks in CLD.

Overall trial start date

01/01/2005

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. 3 - 7 year old children with history of chronic lung disease of infancy
2. Premature birth at 36 weeks gestation or less
3. Clinical and radiological diagnosis of CLD. Patient charts will be reviewed and the x-rays will be reviewed, even if there is no x-ray findings patients will be included if they fulfil the other criteria.
4. Requirement of supplemental oxygen to maintain saturation of 90%, for at least 36 weeks corrected gestation

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

82

Participant exclusion criteria

1. Cardiovascular disease other than patent ductus arteriosus (PDA)
2. Those with severe neurological disease or developmental delay
3. Oxygen requirement for respiratory diagnosis other than CLD, e.g., congenital diaphragmatic hernia and aspiration
4. An inability to perform spirometry or impulse oscillometry (IOS)
5. Noncompliance with therapy
6. Pneumonia

Recruitment start date

01/01/2005

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Canada

Trial participating centre

P.O. Box 951
Ardeyah City
92400
Kuwait

Sponsor information

Organisation

University of Calgary (Canada)

Sponsor details

3330 Hospital Drive NW
Calgary
Alberta
T2N 4N1
Canada

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

m Pharmaceuticals (Canada) - The pharmaceutical company is providing some funding (in the shape of free drug & placebo and spacers for the inhalers)

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

Study protocol in http://www.ncbi.nlm.nih.gov/pubmed/15826314

Publication citations

  1. Study protocol

    Alotaibi S, Johnson D, Montegomery M, Sauve R, Spier S, Inhaled corticosteroids for abnormal pulmonary function in children with a history of chronic lung disease of infancy: study protocol [ISRCTN55153521]., BMC Pulm Med, 2005, 5, 6, doi: 10.1186/1471-2466-5-6.

Additional files

Editorial Notes