Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
30/04/2015
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 David Flynn

ORCID ID

Contact details

Department of Child Health
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom
+44 (0)20 7794 0500 ext 4124
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0256111271

Study information

Scientific title

N of 1 trials of Montelukast (ML) or Singulair™ in childhood asthma

Acronym

Study hypothesis

Does Montelukast improve asthma in n of 1 placebo trials in paediatric patients whose asthma is controlled by inhaled steroid?

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

Respiratory: Asthma

Intervention

Montelukast vs placebo

Intervention type

Drug

Phase

Not Applicable

Drug names

Montelukast

Primary outcome measures

Service outcomes development

Secondary outcome measures

Not provided at time of registration

Overall trial start date

09/09/2001

Overall trial end date

09/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

30 patients, 12 patients recruited 2001-2002

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

30

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

09/09/2001

Recruitment end date

09/09/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Free Hampstead NHS Trust
London
NW3 2QG
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

The Royal Free Hampstead NHS Trust (UK)

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